WOMen and Babies Health and Wellbeing : Action through Trials

Perinatal Trials

This page contains an alphabetical list of maternal perinatal trials from the Australian and New Zealand Clinical Trials Registry (ANZCTR), the International Standard Randomised Controlled Trial Number Register (ISRCT) and the Perinatal Trials Registry (PTR).

WOMBAT TRIALS BOOKLET 2010 *New*

Trial By Status
Maternal Neonatal
Not yet recruiting
Currently recruiting
Accrual complete
Follow-up continuing
Follow-up complete
Study complete
Suspended
Stopped early
Discontinued
Not yet recruiting
Currently recruiting
Accrual complete
Follow-up continuing
Follow-up complete
Study complete
Suspended
Stopped early
Discontinued
Not yet recruiting

Maternal

No. Trial Acronym Trial Title
1 A comparison of fentanyl with pethidine for pain relief during childbirth
2 Cooling for perineal pain relief after childbirth: randomised trial
3 Does telephone peer support and/or a midwife home visit in the early postnatal period increase breastfeeding duration?
4 Improving oral hygiene to reduce the risk of preterm birth: A randomised controlled trial assessing a high intensity educational intervention
5 Online cognitive behaviour therapy for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial. MoodGYM
6 Perinatal treatment of depression
7 Preventing diabetes in pregnancy from progressing to type 2 diabetes
8 Transversus abdominis plane block, performed by an ultrasound or landmark technique, as part of a multimodal analgesic regimen for post caesarean section analgesia: a randomised controlled trial
9 Using the Internet to support breastfeeding duration in regional Western Australia
10 CiPs Candida in Pregnancy Study - Treatment of candidiasis to prevent preterm birth
11 DAME Diabetes and antenatal milk expressing (DAME): a pilot/feasibility study
12 FluMum Maternal influenza vaccination: Improving uptake and evaluating the persistence of immune responses at delivery
13 MCV Study Moxibustion for cephalic version: a feasibility study
14 PUSH Study A pilot randomised control trial on maternal antenatal teaching for pushing in second stage of labour
15 The MPG Trial Metformin for the Prevention of Gestational Diabetes
16 The POPOUT Study Persistent Occipito-Posterior: Outcomes following digital rotation.
17 The WOMAN Trial World Maternal Antifibrinolytic Trial. Tranexamic acid for the treatment of postpartum haemorrhage: an international, randomised, double blind, placebo controlled trial.
18 TILT Timing of induction at Term (TILT): a randomised trial
Neonatal

No. Trial Acronym Trial Title
1 Immunogenicity and safety of acellular pertussis vaccine given at birth in healthy infants
2 The non-thermoregulatory effects of incubator humidity on preterm infants
3 Trial of Hydrocolloid dressing for preterm babies on nasal bubble CPAP
4 APTS Australian Placental Transfusion Study (APTS): Should very preterm babies receive a placental blood transfusion at birth via deferring cord clamping versus standard cord clamping procedures?
5 DINO-II pilot study Determining the docosahexaenoic acid dose to obtain plasma and erythrocyte phospholipid fatty acid profiles in preterm infants comparable to term infant profiles: a dose response pilot study
6 HIPERSPACE Comparing the failure rate of high-flow nasal cannulae (HFNC) versus nasal continuous positive airway pressure (CPAP) as post-extubation respiratory support in premature infants with gestational age of 24 to 32 weeks.
7 PANTS A randomised placebo controlled pilot trial on the safety and efficacy of a probiotic product in reducing all case mortality and definite necrotizing enterocolitis in preterm very low birthweight neonates.
8 PINK Pregnancy iodine and neurodevelopment in kids
9 POINT Safety and efficacy of pentoxifylline as a treatment for preventing the progression of necrotising enterocolitis in preterm neonates - A randomised, placebo controlled pilot trial (POINT)
10 TO2RPIDO Feasibility of a multinational trial of targeted oxygen for the resuscitation of premature infants and their developmental outcome (TO₂RPIDO)
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Currently recruiting

Maternal

No. Trial Acronym Trial Title
1 A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section
2 Cervical occlusion in women with cervical insufficiency
3 Comparison of the Episure Autodetect syringe with the Portex loss-of-resistance syringe: a randomised controlled trial
4 Effect of different diets on gestational diabetes. Can a low glycemic index (GI) diet during pregnancy reduce prevalence of large for gestation age (LGA) amongst gravidas with gestational diabetes (GDM)? – a randomized, controlled trial.
5 Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent fetal blood transfusions for women with red cell alloimmunisation: a randomised controlled trial
6 Hypnosis for nausea and vomiting in early pregnancy: a randomised controlled trial
7 Outpatient Foley catheter vs inpatient Prostin gel for induction of labour
8 Oxytocin as an adjunct to interaction coaching and baby massage to improve bonding in the early postpartum
9 Post partum hypertension risk after non-steroidal analgesic use (excluding paracetamol)
10 Prediction of normal vaginal delivery
11 A*STEROID Australasian Antenatal Study to Evaluate the Role of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability - a randomised controlled trial
12 ARRIVaL Artificial Rupture of membranes single versus Repeat Intra-Vaginal prostaglandins for induction of Labour: a randomised controlled trial
13 Bakri The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia - a randomised controlled trial
14 BBBi Beating the Blues before Birth - individual treatment
15 CHIPS The CHIPS trial: Control of Hypertension In Pregnancy Study
16 CLOSURE What are the effects of different methods of skin and subcutaneous fascia closure on maternal wound complication rates?
17 COSMOS Comparing standard maternity care with one-to-one midwifery support: a randomised controlled trial
18 EpiNo The Epi-No Trial: Effect of intravaginal balloon device on levator trauma in mothers following childbirth
19 Healthier Lifestyles Preventing excess weight gain and gestational diabetes in overweight and obese pregnancies: a research and education project
20 HEPRIN Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction? A randomised trial
21 IDEAL Dietary and lifestyle advice for women with borderline gestational glucose intolerance
22 LIMIT Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial
23 MANGO A randomised controlled trial of caseload midwifery
24 OPRA Outpatient cervical priming for induction of labour
25 OSCAR Trial Women undergoing combined spinal epidural for elective caesarean section, ondansetron 8mg versus placebo to prevent perioperative shivering
26 PLUTO Percutaneous Shunting for Lower-Urinary Tract Obstruction
27 PneuMum Pneumococcal vaccination of Australian Indigenous mothers to see if it protects their babies from ear disease
28 PPROMT Immediate delivery vs expectant care in women with preterm prelabour rupture of the membranes close to term – A randomised clinical trial
29 PREGGIO Pregnancy and Glycaemic Index Outcomes Study comparing a low glycaemic index (GI) diet to a standard healthy diet
30 PROGRESS Progesterone After Previous Preterm Birth for the Prevention of Neonatal Respiratory Distress Syndrome
31 SWITCh A randomised, controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour
32 TBS Twin birth study: a multicentred randomised controlled trial comparing planned caesarean section with planned vaginal birth for twins at 32-38 weeks gestation
33 The COMMAND Trial Parecoxib, celecoxib and paracetamol for pain management following caesarean delivery
34 The MAP Study A double-blind randomised controlled trial of FENO guided asthma therapy and clinical guideline guided asthma therapy in pregnant women with asthma to reduce asthma exacerbations
35 TIPPS Thrombophilia in Pregnancy Prophylaxis Study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic women
36 TWINS TWINS: Timing of Birth at Term- A randomised controlled trial.
37 WEAVE Women's Evaluation of Abuse and Violence Care in General Practice: a cluster randomised controlled trial
38 WIP Weighing In Pregnancy
Neonatal

No. Trial Acronym Trial Title
1 A comparison of axillary and tympanic temperature recording in the preterm and term infant
2 A family tobacco control program to reduce respiratory illness in Indigenous infants.
3 Does early whooping cough (pertussis) vaccination provide earlier antibody protection for infants? A pilot study to determine the appropriate design for a trial of acellular pertussis vaccine given at birth?
4 Efficacy and safety of a new fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in pre term (<30 weeks) neonates - a randomised controlled trial
5 Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near-term (>34 weeks) neonates - a randomised controlled trial
6 High flow support versus continuous positive airway pressure (CPAP) support in non-acute respiratory support for preterm infants from 30 weeks corrected gestation
7 Prebiotic supplementation of formula in preterm neonates: a systematic review and meta-analysis of randomised controlled trials
8 Preventing heat loss in the preterm infant < 30 weeks
9 Prevention of hypothermia in the delivery room for preterm infants <30 weeks gestation
10 Propofol compared to morphine and midazolam for facilitating neonatal intubation: A randomized, controlled trial
11 Randomised, double-blind, placebo-controlled trial of aminophylline in infants less than 12 months of age with bronchiolitis who require intensive care, to assess if aminophylline is superior to placebo in reducing the duration of ventilatory support.
12 BOOST II Which Oxygen saturation level should we use for very premature infants? A randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants
13 CPAP (ACT/NSW) Continuous positive airway pressure (CPAP) weaning trial
14 DETECT Response of premature infants born before 29 weeks gestation to early targeted treatment with indomethacin vs placebo
15 GAS study A multi-site randomised controlled trial comparing bupivacaine (regional) anaesthesia versus sevoflurane (general) anaesthesia for effects on neurodevelopmental outcome and apnoea in infants scheduled for unilateral or bilateral inguinal hernia repair
16 ProPrem The use of probiotics to reduce the incidence of sepsis in premature infants
17 TARDIS Targeted Delivery Suite Intervention Study. A randomised controlled trial of modes of ventilatory support in preterm babies from point of delivery to the neonatal intensive care unit.
18 The CPAP Study (Vic) In very preterm infants who are being extubated to nasal continuous positive airway pressure (CPAP), does a continuous positive airway pressure (CPAP) recruitment maneuvre post extubation improve global and regional end-expiratory lung volume, thoracoabdominal asynchrony and work of breathing when compared to no recruitment maneuvre?
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Accrual complete

Maternal

No. Trial Acronym Trial Title
1 A double blind randomised controlled trial of domperidone and metoclopramide as pro-lactational agents in mothers of preterm infants
2 A randomised controlled trial of the effect of physiotherapy intervention on pelvic floor dysfunction in postpartum women
3 A randomised trial of a multidisciplinary teamcare approach involving obstetric, dietary and clinical psychological input in obese pregnant women to reduce the incidence of gestational diabetes (Fighting obesity from conception)
4 Efficacy and safety of Insulin Detemir versus NPH insulin in pregnant women with type 1 diabetes
5 Epidural Blood Patch – The effect of volume on efficacy – a multi-national, multi-centre, randomised control trial
6 Evaluation of a couple-based program of the effects of Couple CARE (a couple-based program) for couples having their first child on couple relationship adjustment, individual partner mood and parenting competence
7 Expulsion of a retained placenta using acupuncture: a randomised controlled trial
8 Open versus specific questioning to assess pain during anaesthetic follow-up after caesarean birth: a randomised trial
9 Oral misoprostol versus intravenous oxytocin for induction of labour following artificial or spontaneous rupture of membranes: a randomised controlled trial
10 Postnatal perineal pain project
11 The effect of intrathecal pethidine on shivering in women having caesarean sections: a prospective randomised controlled trial
12 The efficacy and feasibility of progressive strength training in the management of glucose control in women with gestational diabetes
13 The use of acupressure wristbands to prevent nausea and vomiting in labour and delivery
14 Three model care pathways for postnatal depression
15 Walking versus lying to prevent hypotension following spinal anaesthesia for caesarean section
16 'Shift your Risk' The feasibility and efficacy of an individualised approach to increase physical activity among women with previous gestational diabetes mellitus
17 Anaemia in pregnancy A prospective randomised trial to study the effect of intravenous iron therapy versus the standard treatment with oral iron for women diagnosed with iron deficiency anaemia in pregnancy
18 BAC Birth after Caesarean (BAC) Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth
19 CiPS pilot Candida in Pregnancy Study - treatment of candidiasis to prevent preterm birth - pilot study
20 EASI Efficacy and side effects of iron supplements for the correction of anaemia in pregnant women: a comparison of high dose vs low dose iron
21 EECV2 Early external cephalic version 2 trial
22 HATCH The effects of antenatal hypnosis on pain relief in labour
23 HOPE Prevention of recurrent pre-eclampsia by folic acid and supplementation in women with hyperhomocysteinaemia
24 MEDSTORM The use of skin conductance monitoring to predict severe hypotension after spinal anaesthesia for elective caesarean section (the MEDSTORM trial)
25 MOVE Improving maternal and child health care for women experiencing violence: collaborative development, implementation and effectiveness of a good practice model
26 PRAM Prospective Randomised Automated versus Mercury blood pressure recordings
27 USES Women’s opinions and experiences of prenatal screening for Down Syndrome
28 WILD A Women and the Induction of Labour Dilemma – Trial A
Neonatal

No. Trial Acronym Trial Title
1 A double blind randomised controlled trial comparing the efficacy and safety of an olive oil based lipid emulsion (Clinoleic) to a soybean oil based lipid emulsion (Intralipid) in very preterm infants requiring parenteral nutrition
2 A randomised crossover trial of two algorithms for managing desaturation episodes in ventilated premature infants
3 Effect of active chest physiotherapy techniques on regional ventilation on preterm infants on ventilatory support
4 Effects of different levels of incubator humidity on temperature and fluid and electrolyte balance in infants born at 28 weeks gestation or less
5 Enteral glucose and electrolyte solution versus IV fluids
6 Hydrocortisone Trial: early adrenal insufficiency in very premature infants
7 Improving the outcome of premature infants – a randomised trial of preventive care at home
8 Positioning to improve lung function in preterm infants requiring ventilatory support
9 Probiotic Eczema Prevention Study
10 Randomised double cross over study of assisted control ventilation (A/C) versus intermittent ventilation (IMV) in preterm babies weaning off ventilation
11 Sensitivity training for parents of preterm infants
12 Study evaluating pantoprazole in neonates and preterm infants with GERD
13 Targeting duration of indomethacin treatment to the PDA constrictive response using echocardiography: a randomised controlled trial
14 Telephone reminders to improve the follow-up rate for neonatal intensive care graduates
15 The effect of sildenafil in preterm infants with evolving chronic lung disease
16 Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial
17 DINO Docosahexaenoic acid (DHA) for the improvement of neurodevelopmental outcome in preterm infants
18 FIFI Father Infant Feeding Initiative: Increasing breastfeeding initiation and duration via education and social support for fathers.
19 Florian In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?
20 Healthy Beginnings Early intervention of multiple home visits to prevent childhood obesity among a disadvantaged population: a home-based randomised controlled trial
21 IFOS Infant fish oil study
22 INIS International Neonatal Immunotherapy Study
23 LessMAS Controlled trial of therapeutic lung lavage in meconium aspiration syndrome: lessMAS
24 LOS Prevention of late onset septicaemia in infants in the neonatal intensive care unit, Mater Mothers’ Hospital
25 PICOP Use of chlorhexidine as a topical antiseptic for the prevention of nosocomial infection in premature neonates <29 weeks: a blinded randomised controlled trial
26 PiPIN A randomised controlled trial on the effects of increasing the protein content of Human Milk Fortifier on growth in preterm infants <31 weeks
27 Resuscitation Trial In extremely low birth weight (ELBW) infants who require positive pressure at birth does the Neopuff Infant Resuscitator compared with the Laerdal Infant Bag improve oxygen saturation measurements in the first ten minutes of life?
28 STINT Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?
29 The SUPPOSE Trial Randomized controlled trial of prophylactic glycerol suppositories on gastric emptying and feed tolerance in premature infants: The Suppose Trial
30 TIC A randomised controlled trial of transferring preterm infants born less than 1600g, from incubator to open cot at lower (1600g) versus higher (1800g) body weight to determine the effects on weight gain, temperature stability and length of hospital stay
31 TIGGA Growth and nutritional status of infants fed formula based on goat milk or cow milk
32 UACC Umbilical Arterial Catheterisation Calculation Study
33 VAMP Evaluation of the VAMP (Venous/Arterial Blood Management Protection) closed method of blood sampling from arterial umbilical catheters in very low weight neonates
34 VIBES Plus A randomised trial of preventative care at home in very preterm infants on neurosensory outcome at 2 years of age
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Follow-up continuing

Maternal

No. Trial Acronym Trial Title
1 A randomised controlled trial on the effects of antenatal vitamin D supplementation to improve vitamin D levels in the maternal and cord blood at birth in vitamin D deficient pregnant women
2 Creative-Arts therapy antenatal psychoeducation program for first-time mothers
3 Helping indigenous women to stop smoking during pregnancy
4 Support for ongoing breastfeeding
5 ACTOMgSO4 Australasian Collaborative Trial of Magnesium Sulphate for the prevention of mortality and cerebral palsy in infants born very preterm
6 ACTORDS Australasian Collaborative Trial of Repeat Doses of corticosteroids for the prevention of neonatal respiratory disease
7 DOMINO A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children
8 MECSH Effects on environmental, child, maternal and family outcomes for children born to at risk mothers (who have one or more risk factors for poorer parental coping) receiving sustained nurse home visiting compared with usual care
9 MIG Gestational Diabetes: pregnancy outcomes in treatment with metformin compared with insulin
10 MOSAIC A GP cluster randomised trial to reduce partner violence among pregnant women and women with pre-school children
Neonatal

No. Trial Acronym Trial Title
1 TRIGR Primary prevention study for Type 1 diabetes in children at risk
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Follow-up complete

Maternal

Neonatal

No. Trial Acronym Trial Title
1 Getting research into practice - a randomised controlled trial of an educational intervention aimed at increasing the uptake of Evidence based guidelines for term prom and for early onset GBS disease
2 Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants
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Study complete

Maternal

No. Trial Acronym Trial Title
1 A group randomised trial of two methods for disseminating a smoking cessation programme to public antenatal clinics: effects on patient outcomes
2 A postnatal support program and its effect on breastfeeding duration
3 A preventative intervention for illicit drug using mothers and their infants
4 A randomised controlled trial of psychological interventions for postnatal depression
5 Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety
6 Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus
7 Diet and exercise in pregnancy: weighing pregnant women to achieve ideal weight gains in pregnancy
8 Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk to supply, and its transfer into milk
9 Effect of maternal egg consumption on breast milk ovalbumin concentration
10 Effect of the "Mother and Baby" program on new mothers' psychological and physical well-being
11 Effectiveness of a modified mother-infant transaction program on outcomes for preterm infants from 3 to 24 months of age
12 Efficacy of an oral health promotion intervention in the prevention of early childhood caries
13 Evaluating the impact of the Belly Bra on back pain in pregnancy
14 Evaluation of a decision aid for women with a breech-presenting baby
15 Intravenous oxytocin bolus of 2 units is superior to 5 units during elective caesarean section
16 Magnesium Sulphate for pain relief after caesarean birth
17 Making Choices for Childbirth: A randomised controlled trial of a decision-aid for informed birth after caesarean
18 Omega-3 fatty acids as a treatment for perinatal depression: randomized double-blind placebo-controlled trial
19 Optimisation of the management of placental delivery in second trimester pregnancy interruption
20 Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial
21 Randomised controlled trial of a decision aid for labour analgesia for primiparous women
22 The Effect of a low glycemic index diet during pregnancy on obstetric outcomes
23 The influence of acupuncture on the induction of labour for women with a postdate pregnancy: a randomised controlled trial
24 Ultrasound guided transversus abdominis plane (TAP) block for analgesia after caesarean surgery
25 ACTS Australasian Collaborative Trial of vitamin C and E supplementation for the prevention of pre-eclampsia
26 ADEPT A randomised controlled trial of a decision aid for prenatal screening and diagnosis
27 BAMBINO A Randomized controlled trial using exercise to reduce gestational diabetes and other adverse maternal and neonatal outcomes in obese pregnant women - the pilot study
28 FOREMOST Fetal intrapartum pulse oximetry: a multicentre randomised controlled trial
29 MILO Oral misoprostol for the induction of labour at term
30 PIVOT Parenteral intravenous optimal treatment for hypertensive emergencies in pregnancy
31 PRISM Program of Resources, Information and Support for Mothers
32 SMILE Prevention of preterm birth by treatment of periodontal disease during pregnancy -the Smile Study
33 SMOOTH study Oral oxycodone analgesia compared with intrathecal morphine for pain relief after caesarean delivery: a randomised controlled trial
34 The Balloon Trial Caesarean section following induction of labour in nulliparous women with and unfavourable cervix: a comparison of three ripening agents - PGE2 gel, single or double balloon catheter.
Neonatal

No. Trial Acronym Trial Title
1 A comparison of propofol and suxamethonium as induction agents for neonatal endotracheal intubation
2 Accuracy of clinical assessment of infant heart rate in the delivery room
3 Dietary nucleotide supplementation
4 Does measuring respiratory function improve neonatal ventilation?
5 Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux
6 Effect of probiotics on atopic dermatitis
7 Nasal versus face mask for multiple-breath washout technique in preterm infants
8 Prevention of low systemic blood flow and brain injury in very preterm babies using milrinone
9 Probiotic allergy prevention study
10 Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial
11 Selenium status of term infants fed selenium-supplemented formula in a randomized dose-response trial
12 Bubbles for babies Randomised controlled trial of headbox oxygen versus CPAP for neonatal respiratory distress in non-tertiary hospitals
13 CAP Caffeine for apnea of prematurity trial
14 COIN COIN Trial: Nasal CPAP (continuing positive airways pressure) or lntubation for very preterm infants at birth. A randomised controlled trial
15 OPIO Optimising preterm infant outcomes: a RCT to evaluate two screening & surveillance methods
16 PINT Premature Infants in Need of Transfusion
17 TAPE Providing parents in a neonatal intensive care unit with audiorecordings of their conversations with neonatologists: a randomised trial
18 TIPP Trial of indomethacin prophylaxis in preterms
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Suspended

Maternal

No. Trial Acronym Trial Title
1 A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women
2 A randomised double blind crossover trial of intranasal versus epidural fentanyl patient controlled analgesia for pain relief after caesarean section
Neonatal

No. Trial Acronym Trial Title
1 NIP Neonatal Inhaled Pentoxifylline for early and delayed treatment of chronic lung disease
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Stopped early

Maternal

No. Trial Acronym Trial Title
1 Self-management versus usual care for the treatment of mastitis following childbirth
2 BBB Beating the blues before birth: Evaluating an Antenatal Depression Treatment Model as a Public Health Priority
3 TPP Toward Parenthood: delivering an antenatal self-help intervention with telephone support for depression, anxiety and parenting difficulties - facilitating the perinatal health journey
Neonatal

No. Trial Acronym Trial Title
1 Phototherapy and patency of the Ductus Arteriosus in extremely preterm infants: a randomised trial
2 Routine neonatal postextubation chest physiotherapy: a randomized controlled trial
3 DART Postnatal dexamethasone in tiny babies: does it do more good than harm?
4 ICE Infant Cooling Evaluation Trial
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Discontinued

Maternal

No. Trial Acronym Trial Title
1 Efficacy of ultrasound guided Transversus Abdominis Plane (TAP) block following major abdominal surgery (elective caesarean section): a randomised controlled trial
2 CHOPP (Childhood Obesity Primary Prevention Study) A pregnancy intervention to reduce postprandial glucose excursions in the primary prevention of paediatric obesity
3 MCMOPS McRoberts manoeuvre or pushing study
4 MORP A prospective comparison of early post-operative analgesia in caesarean section using bilateral ilio-inguinal block and subcutaneous morphine
5 The ICE pilot study Inadvertent dural puncture in labour: Intrathecal catheter versus epidural (The ICE Pilot Study)
6 WILD B Women and the Induction of Labour Dilemma – Trial B
7 WIPPET The effect of levobupivacaine Wound Infusion, for 24 hours, on postoperative pain after caesarean section - a prospective, randomised, double-blind parallel-group placebo controlled clinical trial
Neonatal

No. Trial Acronym Trial Title
1 Effects of early caesarean delivery on perinatal outcomes of intrauterine opiate exposed infants
2 Premie Start Improving neurobehavioural development in preterm infants: a randomised controlled trial of a neonatal intervention
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Trial Details

Trial Title A comparison of axillary and tympanic temperature recording in the preterm and term infant
ANZCTR ACTRN12608000213347
Status Currently recruiting
Type Neonatal
Publications no publication yet - Aug 2010
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Trial Title A comparison of fentanyl with pethidine for pain relief during childbirth
ANZCTR ACTRN12609001027202
Status Not yet recruiting
Type Maternal
Trial Contact degr0013@flinders.edu.au
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Trial Title A comparison of propofol and suxamethonium as induction agents for neonatal endotracheal intubation
Other Reference PT0545
Status Study complete
Type Neonatal
Publications Ghanta S, Abdel-Latif ME, Lui K, Ravindranathan H, Awad J, Oei J. Propofol compared with the morphine, atropine and suxamethonium regimen as induction agents for neonatal endotracheal intubation: a randomized, controlled trial. Pediatrics 2007;119(6):e1248-55.

Ghanta S, Abdel-Latif ME, Oei J, Hari R, Lui K. Comparison of propofol and suxamethonium as induction agents for neonatal endotracheal intubation; a preliminary report of a randomised controlled trial [abstract]. PSANZ 2005
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Trial Title A double blind randomised controlled trial comparing the efficacy and safety of an olive oil based lipid emulsion (Clinoleic) to a soybean oil based lipid emulsion (Intralipid) in very preterm infants requiring parenteral nutrition
Status Accrual complete
Type Neonatal
Trial Contact girish.deshpande@health.wa.gov.au
Publications Deshpande GC, Simmer K, Mori T, Croft K. Parenteral lipid emulsions based on olive oil compared with soybean oil in preterm (<28 weeks' festation)neonates: a randomised controlled trial. J Pediatr Gastroenterol Nutr. 2009 Nov;49(5):619-25

Deshpande GC, Simmer K, Mori TA, Croft KD, Kristensen J. Efficacy and safety of an olive oil compared with soybean oil based lipid emulsion in very preterm (<28 weeks) infants: a randomised controlled trial. Journal of Paediatrics and Child Health 2008;44:A139
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Trial Title A double blind randomised controlled trial of domperidone and metoclopramide as pro-lactational agents in mothers of preterm infants
Other Reference PT0392
Status Accrual complete
Type Maternal
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Trial Title A double-blind randomised controlled trial of FENO guided asthma therapy and clinical guideline guided asthma therapy in pregnant women with asthma to reduce asthma exacerbations
Acronym The MAP Study
ANZCTR ACTRN12607000561482
NHMRC NHMRC455592
Status Currently recruiting
Type Maternal
Trial Contact Peter.Gibson@hnehealth.nsw.gov.au
Publications McLaughlin K, Steel K, McCaffery K, Powell H, Clifton VL, Giles W, Hensley MJ, Gibson PG. Psychosocial characteristics and perceived medication risk in pregnant women with asthma. J Paediatr Child Health. (2010) 46(Suppl. 1): 75 [abstract P081]
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Trial Title A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion for the prevention of uterine atony and post partum haemorrhage at elective caesarean section
ANZCTR ACTRN12607000631404
Status Currently recruiting
Type Maternal
Trial Contact joanne.mockler@med.monash.edu.au
Publications Mockler JC, Wallace EM. The use of oxytocin at elective caesarean section: an Australian and New Zealand survey of practice. PSANZ Darwin 2009 abstract A148/Journal of Paediatrics and Child Health 45 (2009);A10-A71

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Trial Title A family tobacco control program to reduce respiratory illness in Indigenous infants.
ANZCTR ACTRN12609000397213
NHMRC 545203
Status Currently recruiting
Type Neonatal
Publications Johnston V, Walker N, Thomas DP, Glover M, Chang AB , Bullen C, Morris P, Brown N, Vander Hoorn S, Borland R, Segan C, Trenholme A, Mason T, Fenton D and Ellis K. A randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke to reduce respiratory illness in Indigenous infants (STUDY PROTOCOL). BMC Public Health 2010, 10:114doi:10.1186/1471-2458-10-114
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Trial Title A GP cluster randomised trial to reduce partner violence among pregnant women and women with pre-school children
Acronym MOSAIC
ANZCTR ACTRN012607000010493
NHMRC NHMRC 280617
Status Follow-up continuing
Type Maternal
Web Link http://www.latrobe.edu.au/mchr
Publications Taft AJ, Small R, Hegarty KL, Lumley J, Watson LF, Gold L. MOSAIC (Mothers' Advocates In the Community): protocol and sample description of a cluster randomised trial of mentor mother support to reduce intimate partner violence among pregnant or recent mothers. BMC Public Health 2009, 9:159

Taft A, Small R, Hegarty K, Lumley J, Watson L. MOSAIC: The development phase of a randomised community intervention trial to reduce intimate partner abuse and depression in women pregnant or with children under five [abstract]. PSANZ 2003:A30. Results paper in progress March 2010. (MK)
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Trial Title A group randomised trial of two methods for disseminating a smoking cessation programme to public antenatal clinics: effects on patient outcomes
Status Study complete
Type Maternal
Publications Campbell E, Walsh RA, Sanson-Fisher R, Burrows S, Stojanovski E. A group randomised trial of two methods for disseminating a smoking cessation programme to public antenatal clinics: effects on patient outcomes. Tobacco Control 2006;15:97-102 Other: Quit smoking behaviours and intentions and hard-core smoking in NSW. Walsh RA, Paul CL, Tzelepis F, Stojanovski E. Health Promotion Journal of Australia. 2006 17(1), 54-60.
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Trial Title A multi-site randomised controlled trial comparing bupivacaine (regional) anaesthesia versus sevoflurane (general) anaesthesia for effects on neurodevelopmental outcome and apnoea in infants scheduled for unilateral or bilateral inguinal hernia repair
Acronym GAS study
ANZCTR ACTRN012606000441516
NHMRC NHMRC491226
Other Reference NCT00756600
Status Currently recruiting
Type Neonatal
Trial Contact andrew.davidson@rch.org.au, suzette.sheppard@mcri.edu.au
Publications Davidson A, McCann ME, Morton N. Anesthesia neurotoxicity in neonates: the need for clinical research. Anesth Analg. 2007: 105(3); 881-2. (Correspondence) Davidson A, Frawley GP, Sheppard S, Hunt R, Hardy P. Risk factors for apnea after infant inguinal hernia repair. Pediatric Anesthesia 2009:19(4); 402-3. (Comment)
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Trial Title A pilot randomised control trial on maternal antenatal teaching for pushing in second stage of labour
Acronym PUSH Study
ANZCTR ACTRN12608000542392
Status Not yet recruiting
Type Maternal
Publications Phipps H, Charlton S, Dietz HP. 2009. Can antenatal education influence how women push in labour?: A Pilot Randomised Controlled Trial on Maternal Antenatal Teaching for Pushing in Second Stage of Labour (PUSH STUDY). ANZJOG, 49(3):274-278

Phipps H, Charlton S, Dietz HP. Can antenatal education influence how many women push in labour? A pilot randomised control trial on maternal antenatal teaching for pushing in second stage of labour (PUSH STUDY). Journal of Paediatrics and Child Health 2007;43:A67 [A129] (PSANZ 2007)

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Trial Title A postnatal support program and its effect on breastfeeding duration
Other Reference PT0379
Status Study complete
Type Maternal
Publications McDonald SJ, Henderson JJ, Evans SF, Faulkner S, Hagan, R. Effect of an extended midwifery support program on the duration of breastfeeding: a randomised controlled trial [abstract]. PSANZ 2003:A68. McDonald SJ, Henderson JJ, Faulkner S, Evans SF, Hagan R. Effect of an extended midwifery postnatal support programme on the duration of breast feeding: A randomised controlled trial. Midwifery (2010) 26:1;88-100.
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Trial Title A pregnancy intervention to reduce postprandial glucose excursions in the primary prevention of paediatric obesity
Acronym CHOPP (Childhood Obesity Primary Prevention Study)
ISRCTN ISRCTN10344179
NHMRC 512363
Status Discontinued
Type Maternal
Trial Contact j.brandmiller@mmb.usyd.edu.au
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Trial Title A preventative intervention for illicit drug using mothers and their infants
Other Reference PT0378
Status Study complete
Type Maternal
Publications Bartu A, Sharp J, Ludlow J, Doherty DA. Postnatal home visiting for illicit drug-using mothers and their infants: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2006 Oct;46(5):419-26

Bartu A. Listening to drug and alcohol families. PSANZ 2004:PL9
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Trial Title A prospective comparison of early post-operative analgesia in caesarean section using bilateral ilio-inguinal block and subcutaneous morphine
Acronym MORP
ANZCTR ACTRN12605000771651
Status Discontinued
Type Maternal
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Trial Title A prospective randomised trial to study the effect of intravenous iron therapy versus the standard treatment with oral iron for women diagnosed with iron deficiency anaemia in pregnancy
Acronym Anaemia in pregnancy
ANZCTR ACTRN12609000177257
Status Accrual complete
Type Maternal
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Trial Title A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women
ANZCTR ACTRN012605000765628
Status Suspended
Type Maternal
Publications
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Trial Title A randomised controlled trial of a decision aid for prenatal screening and diagnosis
Acronym ADEPT
ISRCTN ISRCTN22532458
NHMRC NHMRC237124
Other Reference PT0513
Status Study complete
Type Maternal
Publications Nagle C, Lewis S, Meiser B, Gunn J, Halliday J, Bell R. Exploring general practitioners' experience of informing women about prenatal screening tests for foetal abnormalities: a qualitative focus group study. BMC Health Services Research 2008; 8:114

Nagle C, Gunn J, Bell R, Lewis S, Meiser B, Metcalfe S, Ukoumunne OC, Halliday J. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]. BJOG 2008;115:339-47

Nagle C, Lewis S, Gunn J, Bell R, Mesier B, Metcalfe S, Ukoumunne O, Halliday J. Improving women's informed choice in prenatal testing of fetal abnormalities. PSANZ Melbourne 2007;abstract A27/Journal of Paediatrics and Child Health 2007;43:A23

Nagle C, Lewis S, Meiser B, Metcalfe S, Carlin JB, Bell R, Gunn J, Halliday J. Evaluation of a decision aid for prenatal testing of fetal abnormalities: a cluster randomised trial [ISRCTN22532458]. BMC Public Health 2006;6:96.

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Trial Title A randomised controlled trial of caseload midwifery
Acronym MANGO
ANZCTR ACTRN12609000349246
NHMRC NHMRC510207
Status Currently recruiting
Type Maternal
Trial Contact Sally.Tracy@SESIAHS.health.nsw.gov.au
Publications ..to add (PM)
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Trial Title A randomised controlled trial of psychological interventions for postnatal depression
Status Study complete
Type Maternal
Publications Milgrom J, Negri LM, Gemmill AW, McNeil M, Martin PR. A randomized controlled trial of psychological interventions for postnatal depression. British Journal of Clinical Psychology 2005;44:529-42
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Trial Title A randomised controlled trial of the effect of physiotherapy intervention on pelvic floor dysfunction in postpartum women
Other Reference PT0514
Status Accrual complete
Type Maternal
Publications
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Trial Title A randomised controlled trial of transferring preterm infants born less than 1600g, from incubator to open cot at lower (1600g) versus higher (1800g) body weight to determine the effects on weight gain, temperature stability and length of hospital stay
Acronym TIC
ANZCTR ACTRN12606000518561
Other Reference PT0427
Status Accrual complete
Type Neonatal
Trial Contact karen_new@health.qld.gov.au
Web Link http://www.anzctr.org.au/trial_view.aspx?ID=1360
Publications Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004214. Transfer of preterm infants from incubator to open cot at lower versus higher body weight. New K, Flenady V, Davies MW.
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Trial Title A randomised controlled trial on the effects of antenatal vitamin D supplementation to improve vitamin D levels in the maternal and cord blood at birth in vitamin D deficient pregnant women
ANZCTR ACTRN12609000142235
Status Follow-up continuing
Type Maternal
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Trial Title A randomised controlled trial on the effects of increasing the protein content of Human Milk Fortifier on growth in preterm infants <31 weeks
Acronym PiPIN
ANZCTR ACTRN012606000525583
Status Accrual complete
Type Neonatal
Publications Miller J, Collins CT, Gibson RA, McPhee AJ, Morris S, Stanford T, Makrides M. The effect of increasing the protein content of human milk fortifier on growth in preterm infants <31 weeks’ gestation: a randomised controlled trial. PSANZ Darwin 2009 abstract A035/Journal of Paediatrics and Child Health 2009;45:A20

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Trial Title A randomised crossover trial of two algorithms for managing desaturation episodes in ventilated premature infants
Status Accrual complete
Type Neonatal
Publications Wilkinson DJ, Andersen CC. A randomised crossover trial of two algorithms for managing desaturation episodes in ventilated premature infants. Journal of Paediatrics and Child Health 2007;43:A141[P105] (PSANZ 2007)
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Trial Title A randomised double blind crossover trial of intranasal versus epidural fentanyl patient controlled analgesia for pain relief after caesarean section
ANZCTR ACTRN012605000327684
Status Suspended
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
Web Link http://www.wirf.com.au
Publications
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Trial Title A randomised placebo controlled pilot trial on the safety and efficacy of a probiotic product in reducing all case mortality and definite necrotizing enterocolitis in preterm very low birthweight neonates.
Acronym PANTS
ANZCTR ACTRN12609000374268
Status Not yet recruiting
Type Neonatal
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Trial Title A randomised trial of a multidisciplinary teamcare approach involving obstetric, dietary and clinical psychological input in obese pregnant women to reduce the incidence of gestational diabetes (Fighting obesity from conception)
ANZCTR ACTRN012605000709640
Other Reference PT0543
Status Accrual complete
Type Maternal
Publications Quinlivan JA. Fighting Obesity from Conception - A randomised trial. PSANZ 2005: P132.
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Trial Title A Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children
Acronym DOMINO
ANZCTR ACTRN012605000569606
NHMRC NHMRC349301
Status Follow-up continuing
Type Maternal
Trial Contact karen.best@cywhs.sa.gov.au
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Trial Title A randomised trial of preventative care at home in very preterm infants on neurosensory outcome at 2 years of age
Acronym VIBES Plus
ANZCTR ACTRN012605000492651
NHMRC NHMRC 284512
Status Accrual complete
Type Neonatal
Publications Spittle AJ, Ferretti C, Anderson PJ, Orton J, Eeles A, Bates L, Boyd RN, Inder TE, Doyle LW. Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home. BMC Pediatrics 2009, 9:73

Doyle LW, Spittle AJ, Eeles A, Ferretti C, Orton J, Anderson PJ, Boyd RN, Reddihough D, Inder TE. A randomised controlled trial of preventative care at home over the first year of life on cognitive and motor outcome for preterm infants at 2 years. PSANZ Darwin 2009;abstract A124/Journal of Paediatrics and Child Health 45 (2009) A10-A71.

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Trial Title A randomised, controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour
Acronym SWITCh
ANZCTR ACTRN12609000964213
Status Currently recruiting
Type Maternal
Publications no publication yet - Aug 2010
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Trial Title A Randomized controlled trial using exercise to reduce gestational diabetes and other adverse maternal and neonatal outcomes in obese pregnant women - the pilot study
Acronym BAMBINO
ANZCTR ACTRN012606000271505
Status Study complete
Type Maternal
Trial Contact katie_foxcroft@health.qld.gov.au
Publications Callaway LK, Colditz PB, Byrne NM, Lingwood BE, Rowlands IJ, Foxcroft K, McIntyre HD; for the BAMBINO group. Prevention of gestational diabetes: Feasibility issues for an exercise intervention in obese pregnant women. Diabetes Care. 2010 Mar 31. [Epub ahead of print]

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Trial Title Accuracy of clinical assessment of infant heart rate in the delivery room
Status Study complete
Type Neonatal
Publications Kamlin COF, O'Donnell CPF, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation 2006;71:319-21
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Trial Title Artificial Rupture of membranes single versus Repeat Intra-Vaginal prostaglandins for induction of Labour: a randomised controlled trial
Acronym ARRIVaL
Status Currently recruiting
Type Maternal
Trial Contact Michael.Beckmann@mater.org.au
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Trial Title Australasian Antenatal Study to Evaluate the Role of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability - a randomised controlled trial
Acronym A*STEROID
ANZCTR ACTRN12608000631303
NHMRC NHMRC
Status Currently recruiting
Type Maternal
Trial Contact pat.ashwood@adelaide.edu.au
Publications Crowther, C, Harding J, Middleton, P, Andersen C, Robinson J. A-STEROID: Child health outcomes at 2 years; corrected age after antenatal exposure to either dexamethasone or betamethasone: a planned randomised controlled trial. IMPACT 18-19 April 2009.

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Trial Title Australasian Collaborative Trial of Magnesium Sulphate for the prevention of mortality and cerebral palsy in infants born very preterm
Acronym ACTOMgSO4
NHMRC NHMRC960489; 350326
Other Reference PT0354
Status Follow-up continuing
Type Maternal
Web Link http://www.health.adelaide.edu.au/og/research/mpctu.html
Publications Crowther CA, Hiller JE, Doyle LW, Haslam RR. Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial. JAMA 2003;290 (20):2669-76

Crowther CA, Hiller JE, Doyle LW. Does prenatal magnesium sulphate reduce the risk of mortality and cerebral palsy in infants born at less than 30 weeks' gestation. The ACTOMGSO4 Trial. [Abstract]. PSANZ 2003 : A4.
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Trial Title Australasian Collaborative Trial of Repeat Doses of corticosteroids for the prevention of neonatal respiratory disease
Acronym ACTORDS
ISRCTN ISRCTN48656428
NHMRC NHMRC981185; 453633
Other Reference PT0349
Status Follow-up continuing
Type Maternal
Trial Contact caroline.crowther@adelaide.edu.au
Web Link http://www.health.adelaide.edu.au/og/research/mpctu.html
Publications Mildenhall L, Battin M, Bevan C, Kuschel C, Harding JE. Repeat prenatal corticosteroid doses do not alter neonatal blood pressure or myocardial thickness: randomised, controlled trial. Pediatrics 2009;123;e646-e652.

Crowther CA et al. Outcomes at 2 years of age after repeat doses of antenatal steroids. New England Journal of Medicine 2007;357(12):1179-89

Crowther CA, Haslam RR, Doyle LW, Harding JE, Hiller JE. Repeat doses of prenatal corticosteroids for women at risk of preterm birth: follow-up of the children at 2 years corrected age in the ACTORDS trial. PSANZ Melbourne 2007; abstract A147 /Journal of Paediatrics and Child Health 2007;43:A76

Crowther CA, Haslam RR, Hiller JE, Doyle LW, Robinson JS. Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial. Lancet 2006; 367(9526):1913-9.

Ashwood PJ, Crowther CA, Willson KJ, Haslam RR, Kennaway DJ, Hiller JE, Robinson JS. Neonatal adrenal function after repeat dose prenatal corticosteroids: a randomized controlled trial. Am J Obstet Gynecol 2006; 194(3):861-7

Crowther, C. A. Repeat Doses of prenatal corticosteroids for women at risk of preterm birth - the ACTORDS Trial. PSANZ 2005:A170.

Ashwood PJ. Cord serum cortisol levels after repeat dose prenatal corticosteroids: a randomised controlled trial - ACTORDS. PSANZ 2005:A119

Crowther CA. Repeat doses of prenatal corticosteroids for women at risk of preterm birth: the ACTORDS Trial 12 month follow up. PSANZ 2006:FC19.1 (179).
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Trial Title Australasian Collaborative Trial of vitamin C and E supplementation for the prevention of pre-eclampsia
Acronym ACTS
ISRCTN ISRCTN00416244
ANZCTR NCT00097110
NHMRC NHMRC207744
Status Study complete
Type Maternal
Web Link http://www.health.adelaide.edu.au/og/research/mpctu.html
Publications Rumbold AR, Crowther CA, Haslam RR, Dekker GA, Robinson JS. Vitamins C and E and the risks of preeclampsia and perinatal complications. NEJM 2006;354:1796-806

Ju H, Rumbold AR, Willson KJ, Crowther CA. Borderline gestational diabetes mellitus and pregnancy outcomes. BMC Pregnancy Childbirth 2008;8:31

Rumbold A, Crowther CA, Haslam RR, Dekker GA, Robinson JS. A comparison of standard national and international definitions of hypertensive disease in a cohort of nulliparous women. PSANZ 2006:P40.

Rumbold A, Crowther CA, Haslam RR, Dekker GA, Robinson JS. Australian collaborative trial of supplements (ACTS) with vitamin C and E for the prevention of pre-eclampsia - a randomised control trial. PSANZ 2006:FC19.2
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Trial Title Australian Placental Transfusion Study (APTS): Should very preterm babies receive a placental blood transfusion at birth via deferring cord clamping versus standard cord clamping procedures?
Acronym APTS
ANZCTR ACTRN12610000633088
Status Not yet recruiting
Type Neonatal
Trial Contact Dr Lucille Sebastian: apts@ctc.usyd.edu.au; Prof. William Tarnow-Mordi: Williamtm@med.usyd.edu.au
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Trial Title Beating the Blues before Birth - individual treatment
Acronym BBBi
ANZCTR ACTRN12609000926235
Status Currently recruiting
Type Maternal
Trial Contact charlene.schembri@austin.org.au
Publications Pubmed search 11 May 2010 (mk); nil found.
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Trial Title Beating the blues before birth: Evaluating an Antenatal Depression Treatment Model as a Public Health Priority
Acronym BBB
ANZCTR ACTR12607000397415
Status Stopped early
Type Maternal
Trial Contact m.kealy@wombatcollaboration.net
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Trial Title Birth after Caesarean (BAC) Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth
Acronym BAC
ISRCTN ISRCTN20269066
NHMRC NHMRC399137
Status Accrual complete
Type Maternal
Trial Contact bac@adelaide.edu.au
Web Link http://www.health.adelaide.edu.au/og/research/mpctu.html
Publications Dodd JM, Crowther CA, Hiller JE, Haslam RR, Robinson JS. Birth after caesarean study-planned vaginal birth or planned elective repeat caesarean for women at term with a single previous caesarean birth: protocol for a patient preference study and randomised trial. BMC Pregnancy Childbirth. 2007 Aug 14;7:17. May, 2010 - BAC being written up presently
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Trial Title Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety
NHMRC NHMRC 222708
Status Study complete
Type Maternal
Publications Austin M-P, Frilingos M, Lumley J, Hadzi-Pavlovic D, Roncolato W, Acland S, Saint K, Segal N, Parker G. Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial. Journal of Affective Disorders 2008 Jan;105(1-3):35-44. Epub 2007 May 8.
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Trial Title Caesarean section following induction of labour in nulliparous women with and unfavourable cervix: a comparison of three ripening agents - PGE2 gel, single or double balloon catheter.
Acronym The Balloon Trial
ANZCTR ACTRN12609000186257
Status Study complete
Type Maternal
Trial Contact craig.pennell@uwa.edu.au
Publications Pennell CE, Henderson JJ, O'Neill MJ, McCleery S, Doherty DA, Dickinson JE. Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel. BJOG 2009;116(11):1443-52 DOI: 10.0000/j1471-0528.2009.02279.x

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Trial Title Caffeine for apnea of prematurity trial
Acronym CAP
ISRCTN ISRCTN???
NHMRC NHMRC108706
Other Reference PT0357
Status Study complete
Type Neonatal
Publications Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Shinha S, Tin W, Caffeine for apnea of prematurity trial group. Caffeine for apnea of prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7.

Doyle LW, Cheong J, Hunt R, Lee K, Thompson D, Davis PG, Rees S, Anderson PJ, Inder TE. Caffeine and brain development in very preterm infants. PSANZ Darwin 2009;abstract A088/Journal of Paediatrics and Child Health 45 (2009) A10-A71.

Schmidt B, Roberts R, Davis PG, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W, for the Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity [abstract]. Journal of Paediatrics and Child Health 2008;44:A12-59

Schmidt B et al. Long-term effects of caffeine therapy for apnea of prematurity. New England Journal of Medicine 2007;357(19):1893-902

Bancalari E. Caffeine for apnea of prematurity. N Engl J Med 2006;354(20):2179-81

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano, A, Tin W. Caffeine therapy for apnea of prematurity. New England Journal of Medicine 2006;354(20):2112-21.

Schmidt, B. Methylxanthine therapy for apnea of prematurity: evaluation of treatment benefits and risks at age 5 years in the international Caffeine for Apnea of Prematurity (CAP) trial. Biol Neonate 2005;88(3):208-13.

Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W and the CAP Investigators. Results from the Caffeine for Apnea of Prematurity (CAP) trial [abstract]. PSANZ 2006
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Trial Title Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus
Status Study complete
Type Maternal
Trial Contact robert.moses@sesiahs.health.nsw.gov.au
Publications Moses RG, Barker M, Winter M, Petocz P, Brand-Miller JC. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus. Diabetes Care 2009;32:996-1000.

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Trial Title Candida in Pregnancy Study - Treatment of candidiasis to prevent preterm birth
Acronym CiPs
NHMRC NHMRC652532
Status Not yet recruiting
Type Maternal
Trial Contact jmorris@med.usyd.edu.au
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Trial Title Candida in Pregnancy Study - treatment of candidiasis to prevent preterm birth - pilot study
Acronym CiPS pilot
ANZCTR ACTRN126090001052224
Status Accrual complete
Type Maternal
Publications Morris J. CiPS – Candida in Pregnancy Study – treatment of candidiasis to prevent preterm birth. IMPACT 18-19 April 2009.
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Trial Title Cervical occlusion in women with cervical insufficiency
Status Currently recruiting
Type Maternal
Trial Contact njsecher@dadlnet.dk
Web Link http://www.cervicalocclusion.com
Publications Secher NJ, McCormack CD, Weber T, Hein M, Helming RB. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion. BJOG 2007;114:649-e6.
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Trial Title COIN Trial: Nasal CPAP (continuing positive airways pressure) or lntubation for very preterm infants at birth. A randomised controlled trial
Acronym COIN
ANZCTR ANZCTRN12606000258550
NHMRC NHMRC148002
Other Reference PT0368
Status Study complete
Type Neonatal
Web Link http://www.bapm.org/trials/view-trial.php?RecordID=19
Publications Morley CJ, Davis PG, Doyle LW, Brion L, Hascoet JM, Carlin J for the COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. New England Journal of Medicine 2008;358:700-8. Morley CJ, Davis PG, Doyle LW, Brion L, Hascoet JM, Carlin J, for the trial collaborators. A randomised controlled trial of nasal CPAP or intubation and ventilation for very preterm infants at birth: the COIN trial. Journal of Paediatrics and Child Health 2007;43:A39 [A64] (PSANZ 2007)
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Trial Title Comparing standard maternity care with one-to-one midwifery support: a randomised controlled trial
Acronym COSMOS
ANZCTR ACTRN012607000073404
NHMRC NHMRC433040
Status Currently recruiting
Type Maternal
Trial Contact m.kealy@wombatcollaboration.net
Web Link http://www.latrobe.edu.au/mchr
Publications McLachlan HL, Forster DA, Davey M-A, Lumley J, Farrell T, Oats J, Gold L, Waldenstrom U, Albers L, Biro M A. (2008) COSMOS: COmparing Standard Maternity care with One-to-one midwifery Support: a randomised controlled trial. (Study Protocol) Open Access: http://www.biomedcentral.com/1471-2393/8/35
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Trial Title Comparing the failure rate of high-flow nasal cannulae (HFNC) versus nasal continuous positive airway pressure (CPAP) as post-extubation respiratory support in premature infants with gestational age of 24 to 32 weeks.
Acronym HIPERSPACE
ANZCTR ACTRN12610000166077
Status Not yet recruiting
Type Neonatal
Trial Contact brett.manley@thewomens.org.au
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Trial Title Comparison of the Episure Autodetect syringe with the Portex loss-of-resistance syringe: a randomised controlled trial
ANZCTR ACTRN12609000041257
Status Currently recruiting
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
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Trial Title Continuous positive airway pressure (CPAP) weaning trial
Acronym CPAP (ACT/NSW)
ANZCTR ACTRN012606000155594
Status Currently recruiting
Type Neonatal
Trial Contact david.todd@act.gov.au
Publications Todd DA, Shabolt B, Wright A, Chauhan M, Cameron C, Jardine L, Broom M. CPAP weaning: Impacct on time of CPAP and oxygen duration?. J Paediatr Child Health. (2010) 46(Suppl. 1): 46 [abstract A143] Broom M, Chauhan M, Meskell S, Cameron K, Wright A, Cameron C, Padernia A, Rochefort M, Jardine L, Stewart A, Ramakrishnan S, Shabolt B, Todd D. A multi-centre RCT comparing CPAP weaning methods in neonates <30 weeks gestation. PSANZ Darwin 2009; P016/Journal of Paediatrics and Child Health 45;(2009);A74-A125.

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Trial Title Controlled trial of therapeutic lung lavage in meconium aspiration syndrome: lessMAS
Acronym LessMAS
ANZCTR ACTRN12606000290594
NHMRC NHMRC284539
Other Reference PT0535
Status Accrual complete
Type Neonatal
Web Link http://www.rch.org.au/neonatal_rch/research.cfm?doc_id=6953
Publications Dargaville PA, Copnell B, Mills JF, Carlin JB, Morley CJ, for the less MAS trial study group. Randomised controlled trial of lung lavage with dilute surfactant for meconium aspiration syndrome. J Paediatr Child Health. (2010) 46(Suppl. 1): 49 [abstract A155]
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Trial Title Cooling for perineal pain relief after childbirth: randomised trial
ANZCTR ACTRN12607000557437
Status Not yet recruiting
Type Maternal
Trial Contact eastc@unimelb.edu.au
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Trial Title Creative-Arts therapy antenatal psychoeducation program for first-time mothers
ANZCTR ACTRN012606000051549
Status Follow-up continuing
Type Maternal
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Trial Title Determining the docosahexaenoic acid dose to obtain plasma and erythrocyte phospholipid fatty acid profiles in preterm infants comparable to term infant profiles: a dose response pilot study
Acronym DINO-II pilot study
ANZCTR ACTRN12610000382077
Status Not yet recruiting
Type Neonatal
Trial Contact carmel.collins@health.sa.gov.au
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Trial Title Diabetes and antenatal milk expressing (DAME): a pilot/feasibility study
Acronym DAME
Status Not yet recruiting
Type Maternal
Trial Contact kmcegan@mercy.com.au
Publications Forster D, McEgan K, Moorhead A, Ford R, Walker S, Opie G, McNamara C. Diabetes and antenatal milk expressing (DAME): a pilot project to inform the development of a randomised controlled trial. PSANZ Darwin 2009 abstract A188/Journal of Paediatrics and Child Health 45 (2009);A65

Forster DA, McEgan K, Ford R, Moorhead A, Opie G, Walker S, McNamara C. Diabetes and antenatal milk expressing: a pilot project to inform the development or a randomised controlled trial. Midwifery (2009), doi:10.1016/j.midw.2009.05.009
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Trial Title Diet and exercise in pregnancy: weighing pregnant women to achieve ideal weight gains in pregnancy
ANZCTR ACTRN012607000272493
Status Study complete
Type Maternal
Publications Jefferies K, Shub A, Walker S, Hiscock R, Permezel M. Reducing excessive weight gain in pregnancy: a randomised controlled trial. MJA 2009;191:8:429-33

Jefferies K, Shub A, Walker S, Hiscock R, Permezel M. Reducing excessive weight gain in pregnancy: a randomised controlled trial. PSANZ Darwin 2009 abstract A189/Journal of Paediatrics and Child Health 45(2009)A65

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Trial Title Dietary and lifestyle advice for women with borderline gestational glucose intolerance
Acronym IDEAL
ANZCTR ACTRN012607000174482
Status Currently recruiting
Type Maternal
Trial Contact ideal@adelaide.edu.au or andrea.deussen@adelaide.edu.au
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Trial Title Dietary nucleotide supplementation
Status Study complete
Type Neonatal
Web Link http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15294538&dopt=Abstract
Publications Hawkes JS, Gibson RA, Roberton D, Makrides M. Effect of dietary nucleotide supplementation on growth and immune function in term infants: a randomized controlled trial. European Journal of Clinical Nutrition 2006;60:254-64
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Trial Title Docosahexaenoic acid (DHA) for the improvement of neurodevelopmental outcome in preterm infants
Acronym DINO
ANZCTR ACTRN012606000327583
NHMRC NHMRC250322; 508003
Other Reference PT0424
Status Accrual complete
Type Neonatal
Publications Smithers LG, Collins CT, Simmonds LA, Gibson RA, McPhee A, Makrides M. Feeding preterm infants milk with a higher dose of docosahexaenoic acid than that used in current practice does not influence language or behavior in early childhood: a follow-up study of a randomized controlled trial. Am J Clin Nutr 2010 Mar;91(3):628-34

Collins CT, Makrides M, Gibson RA, Ryan P, Mcphee AJ, Dino Steering Committee. Growth outcomes from the DINO (DHA for the improvement of neurodevelopmental outcome in preterm infants) trial. J Paediatr Child Health. (2010) 46(Suppl. 1): 76 [abstract P083]

Manly BJ, Makrides M, Collins CT, Gibson RA, Ryan P, Davis PG, for the DINO Steering Committee. Allergy and respiratory outcomes from the DINO (DHA for the improvement of Neurodevelopmental outcome in preterm infants) Trial. J Paediatr Child Health. (2010) 46(Suppl. 1): 39 [abstract A120]

Smithers LG, Collins CT, Simmonds LA, Gibson RA, McPhee AJ, Makrides M. Higher-dose docosahexaenoic acid (DHA) does not influence language or behaviour: A follow up of the DINO (DHA for the improvement of neurodevelopmental outcome in preterm infants) trial. J Paediatr Child Health. (2010) 46(Suppl. 1): 39 [abstract A119]

Makrides M, Gibson RA, McPhee AJ, Collins CT, Davis PG, Doyle LW, Simmer K, Colditz PB, Morris S, Smithers LG, Willson K, Ryan P. Neurodevelopmental outcomes of preterm infants fed high-dose docosahexaenoic acid: a randomised controlled trial. JAMA. 2009;301(2):175-182

Smithers LG, Gibson RA, McPhee A, Makrides M. Effect of two doses of docosahexaenoic acid (DHA) in the diet of preterm infants on infant fatty acid status: results from the DINO trial. Prostaglandins Leukot Essent Fatty Acids. 2008 Sep-Nov;79(305):141-6

Makrides M, Gibson RA, Collins CT, McPhee AJ, Ryan P, Davis PG, Doyle LW, Simmer K, French N, Morris S, Colditz P, Wilson K, Best K. Does high-dose DHA improve neurodevelopment of preterm infants? DINO trial outcomes. Journal of Paediatrics and Child Health 2008;44:A3

Best K, McDermott BJ, Griffith EC, Collins CT, Gibson RA, Makrides M, Ryan P. An integrated study management system in large randomised trials: the DINO trial. Journal of Paediatrics and Child Health 2008;44:A82

Smithers LG, Gibson RA, Makrides M. Long-chain polyunsaturated fatty acid supplementation for infants born preterm. NeoReviews 2007; 8: 143-51.

Collins CT, Gibson RA, Miller J, McPhee AJ, Willson K, Smithers LG, Makrides M. Carbohydrate intake is the main determinant of growth in infants born <33 weeks' gestation when protein intake is adequate. Nutrition 24 2008, 451-457

Collins, CT. Enteral feeding practices in infants <33 weeks gestation DINO [abstract]. PSANZ 2006: P27.

Collins CT, Miller J, Gibson RA, McPhee AJ, Makrides M. Characterising the nutritional intake of infants <33 weeks gestation. Nutrition Society of Australia, Melbourne, Nov 2005

Best K, Makrides M, Gibson RA, Collins CT. A pragmatic trial with an industry interface - A coordinators Perspective. Australasian Health and Research Data Managers Association, Melbourne, Oct 2005.

Griffith EC, McDermott B, Best K, Makrides M, Gibson RA, Ryan P. The DINO Trial - Use of an integrated study management system. Australasian Health and Research Data Managers Association, Melbourne Oct 2005.

Collins CT. Characterising the nutritional intake of preterm infants <= 32 weeks gestation DINO. [abstract]. PSANZ 2005: A41.

Collins CT, Gibson RA, McCusker S, Best K, McPhee AJ for the DINO Trial Group. A pragmatic trial with an industry interface: the DINO experience. Interdisciplinary Maternal and Perinatal Clinical trial (IMPACT) Network, Adelaide March 2005

Smithers LG, Gibson RA, McPhee A, Makrides M. Higher dose of docosahexaenoic acid in the neonatal period improved visual acuity of preterm infants: results of a randomised controlled trial. Am J Clin Nutr 2008;88:1049-56.

Smithers L. Omega-3 oils improve the way preterm infants see the world. [abstract]. 2008 Young Investigator Award.

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Trial Title Does early whooping cough (pertussis) vaccination provide earlier antibody protection for infants? A pilot study to determine the appropriate design for a trial of acellular pertussis vaccine given at birth?
ANZCTR ACTRN012605000013662
Status Currently recruiting
Type Neonatal
Trial Contact NicholW3@chw.edu.au
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Trial Title Does heparin improve pregnancy outcomes for women with evidence of placental dysfunction? A randomised trial
Acronym HEPRIN
ISRCTN ISRCTN88675588
Status Currently recruiting
Type Maternal
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Trial Title Does measuring respiratory function improve neonatal ventilation?
Status Study complete
Type Neonatal
Publications Klimek J, Morley C, Lau R. and Davis P. (2006). Does measuring respiratory function improve neonatal ventilation? Journal of Paediatrics and Child Health, 42: 140-2.
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Trial Title Does telephone peer support and/or a midwife home visit in the early postnatal period increase breastfeeding duration?
ISRCTN ISRCTN17386721
Status Not yet recruiting
Type Maternal
Publications Forster D, McLachlan H, Davey M-A, Amir L, Gold L. Does telephone peer support in the early postnatal period increase breastfeeding duration: A randomised controlled trial. IMPACT 18-19 April 2009.
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Trial Title Does the use of an introducer (stylet) improve the success rate at orotracheal intubation in newborn infants?
Acronym STINT
ANZCTR ACTRN0120607000186459
Status Accrual complete
Type Neonatal
Publications Dawson J, O’Connell L, Kamlin O, O’Donnell C, Davis P, Morley C. Stylet for orotracheal intubation in newborn infants (Stint Study) – a randomised controlled trial. PSANZ Darwin 2009 abstract A020/Journal of Paediatrics and Child Health 45 (2009);A10 (A71)

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Trial Title Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk to supply, and its transfer into milk
Status Study complete
Type Maternal
Trial Contact ken.ilett@uwa.edu.au
Publications Wan E, Davey K, Page-Sharp M, Hartmann PE, Simmer K, Ilett KF. Dose-effect study of domperidone as a galactagogue in preterm mothers with insufficient milk to supply, and its transfer into milk. Br J Clin Pharmacol 2008;66(2):283-289
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Trial Title Early external cephalic version 2 trial
Acronym EECV2
ISRCTN ISRCTN74892692
Other Reference PT0542
Status Accrual complete
Type Maternal
Web Link http://www.utoronto.ca/miru/eecv2
Publications Hutton EK for the EECV2 Trial Collaborative Group. Early ECV 2 trial. PSANZ Melbourne 2007; abstract P46/Journal of Paediatrics and Child Health 2007;43:A117

Hutton E. Early ECV2 Trial. PSANZ 2006:P88(369).

Hutton E. The Early External Cephalic Version 2 Trial. PSANZ 2003:P97. As at 9th June: publication submitted for publication awaiting review. (JF)
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Trial Title Early intervention of multiple home visits to prevent childhood obesity among a disadvantaged population: a home-based randomised controlled trial
Acronym Healthy Beginnings
ANZCTR ACTRN12607000168459
Status Accrual complete
Type Neonatal
Trial Contact lmwen@email.cs.nsw.gov.au
Publications Wen LM, Flood VM, Simpson JM, Rissel C, Baur LA. Dietary behaviours during pregnancy: findings from first-time mothers in southwest Sydney, Australia. Int J Behav Nutr Phys Act 2010 Feb 3;7:13

Wen LM, Baur LA, Simpson JM, Rissel C. Mothers' awareness of their weight status and concern about their children being overweight: findings from first-time mothers in south-west Sydney. Aust NZ J Public Health 2010;34:293-7

Wen LM, Baur LA, Rissel C, Alpenstein G, Simpson JM. Intention to breastfeed and awareness of health recommendations: finding from first-time mothers in southwest Sydney, Australia. Int Breastfeed J. 2009 Oct 16;4:9

Wen LM, Baur LA, Rissel C, Wardle K, Alperstein G, Simpson JM. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial). BMC Public Health 2007;7:76
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Trial Title Effect of active chest physiotherapy techniques on regional ventilation on preterm infants on ventilatory support
ANZCTR ACTRN012606000211561
Status Accrual complete
Type Neonatal
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Trial Title Effect of different diets on gestational diabetes. Can a low glycemic index (GI) diet during pregnancy reduce prevalence of large for gestation age (LGA) amongst gravidas with gestational diabetes (GDM)? – a randomized, controlled trial.
ANZCTR ACTRN12608000218392
Status Currently recruiting
Type Maternal
Trial Contact j.louie@student.usyd.edu.au
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Trial Title Effect of maternal egg consumption on breast milk ovalbumin concentration
Status Study complete
Type Maternal
Trial Contact maria.makrides@cywhs.sa.gov.au
Publications Palmer DJ, Gold MS, Makrides M. Effect of maternal egg consumption on breast milk ovalbumin concentration. Clinical and Experimental Allergy 2008, 38, 1186-91
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Trial Title Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux
Status Study complete
Type Neonatal
Publications Omari TI, Haslam RR, Lundborg P, Davidson GP. Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux. Journal of Pediatric Gastroenterology and Nutrition 2007;44:41-4
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Trial Title Effect of probiotics on atopic dermatitis
Status Study complete
Type Neonatal
Publications Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis. Arch Dis Child 2005;90:892-7

Prescott SL, Dunstan JA, Hale J, Breckler L, Lehmann H, Weston S, Richmond P. Clinical effects of probiotics are associated with increased interferon-y responses in very young children with atopic dermatitis. Clin Exp Allergy 2005;35:1557-64.

Weston S, Richmond P, Halbert A, Prescott SL. Effects of probiotics in infants with atopic dermatitis: a randomised double blind placebo controlled trial. The Australasian College of Dermatologists 37th Annual Meeting 2004.
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Trial Title Effect of the "Mother and Baby" program on new mothers' psychological and physical well-being
Other Reference NCT00361478
Status Study complete
Type Maternal
Publications Norman E, Sherburn M, Osborne RH, Galea MP. An exercise and education program improves well-being of new mothers: a randomised controlled trial. Physical Therapy 2010;90:348-55

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Trial Title Effectiveness of a modified mother-infant transaction program on outcomes for preterm infants from 3 to 24 months of age
Status Study complete
Type Maternal
Trial Contact carol.newnham@austin.org.au
Publications Newnham CA, Milgrom J, Skouteris H. Effectiveness of a modified mother-infant transaction program on outcomes for preterm infants from 3 to 24 months of age. Infant Behavior & Development 32 (2009); 17-26

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Trial Title Effects of different levels of incubator humidity on temperature and fluid and electrolyte balance in infants born at 28 weeks gestation or less
ANZCTR ACTRN012606000138583
Status Accrual complete
Type Neonatal
Publications Kong YS, Singh S, Tiong YL, Woo D, Cheung F, Cheong JLY, Courtot JE, Jolley D, Martin C, Kotsanas D, Medhurts AM. A randomised controlled trial to compare the effect of 80% and 70% incubator humidity on the body temperture of infants born at 28 weeks gestation or less: secondary outcomes. Journal of Paediatrics and Child Health 46 (Suppl.1) 2010:57-96; [abstract P062]

Kong YS, Singh S, Tiong YL, Woo D, Cheung F, Courtot JE, Cheong JLY, Jolley D, Kotsanas D, Medhurst AM. A randomised controlled trial to compare the effect of 80% and 70% incubator humidity on the body temperature of infants born at 28 weeks gestation or less. PSANZ Darwin 2009 abstract A059/Journal of Paediatrics and Child Health 45 (2009);[abstract A27]

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Trial Title Effects of early caesarean delivery on perinatal outcomes of intrauterine opiate exposed infants
Status Discontinued
Type Neonatal
Publications Liu A, Kirby A, Nanan R. Effect of early Caesarean delivery on perinatal outcomes of intrauterine opiate exposed infants. IMPACT 18-19 April 2009.
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Trial Title Effects on environmental, child, maternal and family outcomes for children born to at risk mothers (who have one or more risk factors for poorer parental coping) receiving sustained nurse home visiting compared with usual care
Acronym MECSH
ANZCTR ACTRN12608000473369
Status Follow-up continuing
Type Maternal
Trial Contact l.kemp@unsw.edu.au
Publications Kemp L, Harris E, McMahon C, Matthey S, Vimpani G, Anderson T, Schmeid V. Miller early childhood sustained home-visiting (MECSH) trial: design, method and sample description. BMC (2008) 8:424
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Trial Title Efficacy and safety of a new fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in pre term (<30 weeks) neonates - a randomised controlled trial
ANZCTR ACTRN12609001017213
Status Currently recruiting
Type Neonatal
Trial Contact drgirishdeshpande@gmail.com
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Trial Title Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near-term (>34 weeks) neonates - a randomised controlled trial
ANZCTR ACTRN12609000337279
Status Currently recruiting
Type Neonatal
Trial Contact girish.deshpande@health.wa.gov.au
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Trial Title Efficacy and safety of esomeprazole once daily for the treatment of GERD in neonatal patients
Other Reference NCT00427635
Status Accrual complete
Type Not Recorded
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Trial Title Efficacy and safety of Insulin Detemir versus NPH insulin in pregnant women with type 1 diabetes
Other Reference NCT00474045
Status Accrual complete
Type Maternal
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Trial Title Efficacy and side effects of iron supplements for the correction of anaemia in pregnant women: a comparison of high dose vs low dose iron
Acronym EASI
Other Reference PT0538
Status Accrual complete
Type Maternal
Publications Zhou SJ, Makrides M, Gibson RA. Effect of iron supplementation in pregnancy on iron status of children at 6 months and 4 years - long term follow up of a randomised controlled trial. J Paediatr Child Health. (2010) 46(Suppl. 1): 96 [abstract P158]

Zhou SJ, Gibson RA, Crowther CA, Makrides M. Should we lower the dose of iron when treating anaemia in pregnancy? a randomized-dose response trial. Eur J Clin Nutr 2009 63,183-190.

Zhou SJ, Gibson RA, Crowther CA, Makrides M. Efficacy and side effects of iron supplements for the correction of anaemia in pregnancy: a comparison of high dose vs. low dose iron. PSANZ Melbourne 2007; abstract A42/Journal of Paediatrics and Child Health 2007;43:A30

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Trial Title Efficacy of an oral health promotion intervention in the prevention of early childhood caries
Status Study complete
Type Maternal
Trial Contact kamila.plutzer@adelaide.edu.au
Publications Plutzer K, Spencer AJ. Efficacy of an oral health promotion intervention in the prevention of early childhood caries. Community Dent Oral Epidemiol 2008; 36:335-46

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Trial Title Efficacy of ultrasound guided Transversus Abdominis Plane (TAP) block following major abdominal surgery (elective caesarean section): a randomised controlled trial
ANZCTR ACTRN012607000389404
Status Discontinued
Type Maternal
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Trial Title Enteral glucose and electrolyte solution versus IV fluids
Status Accrual complete
Type Neonatal
Publications Collins CL, Joshi D, Wilson D, Andersen CC. Enteral glucose and electrolyte solution versus IV fluids; a randomised controlled trial in newborns. Journal of Paediatrics and Child Health 2007;43:A93[PO35] (PSANZ 2007)
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Trial Title Epidural Blood Patch – The effect of volume on efficacy – a multi-national, multi-centre, randomised control trial
ANZCTR ACTRN012605000319673
Status Accrual complete
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
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Trial Title Evaluating the impact of the Belly Bra on back pain in pregnancy
ANZCTR ACTRN012605000270617
Status Study complete
Type Maternal
Publications Kalus SM, Kornman LH, Quinlivan JA. Evaluating the impact of the belly bra on back pain in pregnancy [abstract]. PSANZ 2006:PS2.7(219).

Kalus SM, Kornman LH, Quinlivan JA. Managing back pain in pregnancy using a support garment: a randomised trial. BJOG 2008;115:68-75

Mogri R, Kornman L, Quinlivan JA. Back pain in pregnancy. PSANZ 2005:P101.
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Trial Title Evaluation of a couple-based program of the effects of Couple CARE (a couple-based program) for couples having their first child on couple relationship adjustment, individual partner mood and parenting competence
ANZCTR ACTRN01260700002646
Status Accrual complete
Type Maternal
Publications Halford WK, Petch J, Creedy D. Promoting a positive transition to parenthood: a randomised clinical trial of couple relationship education. Prev Sci (2010) 11:89-100 Petch J, Halford WK. Psycho-education to enhance couples' transition to parenthood. Clinical Psychology Review 28 (2008);1125-37

Halford WK, Petch J. Couple psychoeducation for new parents: observed and potential effects on parenting. Clin Child Fam Psychol Rev. 2010 Jun;13(2):164-80.
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Trial Title Evaluation of a decision aid for women with a breech-presenting baby
ISRCTN ISRCTN14570598
NHMRC NHMRC211051; 262041
Other Reference PT0383
Status Study complete
Type Maternal
Web Link http://www.health.usyd.edu.au/shdg/projects.htm
Publications Nassar N, Roberts CL, Raynes-Greenow CH, Barratt A, Peat B on behalf of the Decision Aid for Breech Presentation Trial Collaborators. Evaluation of a decision aid for women with a breech presentation at term: a randomised controlled trial [ISRCTN14570598]. British Journal of Obstetrics and Gynaecology 2007;114:325-33

Nassar N, Roberts CL, Raynes-Greenow CH, Barratt A. Development and pilot-testing of a decision aid for women with a breech-presenting baby. Midwifery 2007;23(1):38-47 Epub 2006.

Roberts CL, Nassar N, Barratt A, Raynes-Greenow CH, Peat B, Henderson-Smart D. Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598]. BMC Pregnancy Childbirth 2004;4(1):26.

Nassar, N. Evaluation of an ECV decision aid for pregnant women with a breech-presenting baby: a randomised controlled trial. PSANZ 2005:A168.
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Trial Title Evaluation of the VAMP (Venous/Arterial Blood Management Protection) closed method of blood sampling from arterial umbilical catheters in very low weight neonates
Acronym VAMP
Other Reference PT0358
Status Accrual complete
Type Neonatal
Publications Tudehope D, Morris S, Hodby G, Tilse M, Flenady V, Woodgate P, Jenkins-Manning S The VAMP Trial: A randomised controlled trial of a closed method of blood sampling in very low birthweight infants. PSANZ 2003:A3.
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Trial Title Expulsion of a retained placenta using acupuncture: a randomised controlled trial
Other Reference PT0347
Status Accrual complete
Type Maternal
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Trial Title Father Infant Feeding Initiative: Increasing breastfeeding initiation and duration via education and social support for fathers.
Acronym FIFI
ANZCTR ACTRN12609000667213
Status Accrual complete
Type Neonatal
Trial Contact j.tohotoa@curtin.edu.au
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Trial Title Feasibility of a multinational trial of targeted oxygen for the resuscitation of premature infants and their developmental outcome (TO₂RPIDO)
Acronym TO2RPIDO
Status Not yet recruiting
Type Neonatal
Trial Contact see_kwee_ching@yahoo.com
Publications See KC, Oei J, Clark R, Lui K for the TO2RPIDO Multinational Study Group. Feasibility of a randomised trial of targeted oxygen for the resuscitation of premature infants and their developmental outcome (TO₂RPIDO). PSANZ Darwin 2009 abstract A017/Journal of Paediatrics and Child Health 45 (2009);A10 (A71)

Ching SK, Oei J, Clark R, Lui K. Feasibility of a Multinational Trial of Targeted Oxygen for the Resuscitation of Premature Infants and Their Developmental Outcome (TO₂RPIDO). IMPACT 18-19 April 2009.

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Trial Title Fetal intrapartum pulse oximetry: a multicentre randomised controlled trial
Acronym FOREMOST
ANZCTR ACTRN012606000307505
NHMRC NHMRC301050
Other Reference PT0360
Status Study complete
Type Maternal
Publications East CE, Brennecke SP, King JF, Chan FY, Colditz PB, on behalf of the FOREMOST Study Group. The effect of intrapartum fetal pulse oximetry, in the presence of a nonreassuring fetal heart rate pattern, on operative delivery rates: a multicenter, randomized, controlled trial (the FOREMOST trial). American Journal of Obstetrics and Gynecology 2006; 194(3):606-16.

East CE, Chan FY, Brennecke SP, King JF, Colditz PB. Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial). Birth 2006; 33(2):101-9.

East, C. E., Brennecke, S. P., Chan, F. Y., King, J. F., Beller, E. M., Colditz, P. B. Clinicians' evaluations of fetal oximetry sensor placement in a multicentre randomised trial (the FOREMOST trial). Aust N Z J Obstet Gynaecol 2006; 46 (3) : 234-9.

East, C. E., Gascoigne, M. B., Doran, C. M., Brennecke, S. P., King, J. F., Colditz, P. B. A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial). Bjog 2006; 113(9): 1080-7.

East, C E The effect of intrapartum fetal pulse oximetry, in the presence of a non-reassuring fetal heart rate pattern, on operative delivery rates: a multicenter randomised controlled trial (The Foremost Trial). AJOG 2005; 193 (6 suppl).

East, CE. A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomized controlled trial (the Foremost Trial). AJOG 2005; 193 (6 suppl).

East, C E Women's evaluations of their experience in a multicentre randomized controlled trial of intrapartum fetal pulse oximetry (The Foremost Trial). AJOG 2005; 193 (6 suppl).
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Trial Title Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent fetal blood transfusions for women with red cell alloimmunisation: a randomised controlled trial
ANZCTR ACTRN12608000643370
Status Currently recruiting
Type Maternal
Trial Contact jodie.dodd@adelaide.edu.au
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Trial Title Gestational Diabetes: pregnancy outcomes in treatment with metformin compared with insulin
Acronym MIG
ANZCTR ACTRN012605000266662
NHMRC NHMRC 250403
Other Reference PT0521
Status Follow-up continuing
Type Maternal
Publications Rowan JA, Hague WM, Wanzhen G, McIntyre HD. Glycemia and its relationship to outcomes in the metformin in gestational diabetes trial. Diabetes Care 2010;33:1:9-16

Rowan JA, Hague WM, Wanzhen G, Battin MR, Moore MP for the MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. New England Journal of Medicine 2008;358(19):2003-15

Rowan J, Hague W. Gestational diabetes: a randomized trial of metformin compared with insulin - the Metformin in Gestational Diabetes (MIG) trial. Journal of Paediatrics and Child Health 2008;44:A26

Rowan JA on behalf of the MiG Investigators. A trial in progress: Gestational diabetes; Treatment with metformin compared with insulin (the Metformin in Gestational Diabetes [MiG] trial). Diabetes Care 2007;30(suppl 2):S214-9.

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Trial Title Getting research into practice - a randomised controlled trial of an educational intervention aimed at increasing the uptake of Evidence based guidelines for term prom and for early onset GBS disease
Status Follow-up complete
Type Neonatal
Trial Contact v.flenady@wombatcollaboration.net
Publications King JF, Flenady V, Kilgour C, Woodgate P, Coory M, Shannon C. Getting Research into Practice - A randomised controlled trial of an educational intervention aimed at increasing the uptake of evidence based guidelines for termprom and for early onset GBS disease. [ABSTRACT] PSANZ 2000:A18.
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Trial Title Growth and nutritional status of infants fed formula based on goat milk or cow milk
Acronym TIGGA
ANZCTR ACTRN12608000047392
Status Accrual complete
Type Neonatal
Trial Contact jo.zhou@adelaide.edu.au
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Trial Title Helping indigenous women to stop smoking during pregnancy
ANZCTR ACTRN12609000929202
NHMRC NHMRC320851
Status Follow-up continuing
Type Maternal
Publications Panaretto KS, Mitchell MR, Anderson L, Gilligan C, Buettner P, Larkins SL, Eades S. Tobacco use and measuring nicotine dependence among urban Indigenous pregnant women. MJA 2009;191: 554-557 Indigenous women and smoking during pregnancy: knowledge, cultural contexts and barriers to cessation. Social Science & Medicine 2008; 66(11), 2378-2389

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Trial Title High flow support versus continuous positive airway pressure (CPAP) support in non-acute respiratory support for preterm infants from 30 weeks corrected gestation
ANZCTR ACTRN12610000677000
Status Currently recruiting
Type Neonatal
Trial Contact Ashley McEwan: ashley.mcewan@hotmail.com
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Trial Title Hydrocortisone Trial: early adrenal insufficiency in very premature infants
Other Reference PT0364
Status Accrual complete
Type Neonatal
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Trial Title Hypnosis for nausea and vomiting in early pregnancy: a randomised controlled trial
ANZCTR ACTRN012607000127404
Status Currently recruiting
Type Maternal
Trial Contact allan.cyna@health.sa.gov.au
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Trial Title Immediate delivery vs expectant care in women with preterm prelabour rupture of the membranes close to term – A randomised clinical trial
Acronym PPROMT
ISRCTN ISRCTN44485060
NHMRC NHMRC358378
Other Reference PT0536
Status Currently recruiting
Type Maternal
Trial Contact ppromt@med.usyd.edu.au
Web Link http://www.wombatcollaboration.net/doc/InfoSheet_PPROMT_0307.pdf
Publications Morris J, Roberts CL, Levett K, Crowther C. Immediate delivery vs expectant care in women with preterm prelabour rupture of the membranes close to term (PPROMT) – a randomised controlled trial. PSANZ Darwin 2009: abstract P074/Journal of Paediatrics and Child Health 45 (2009);A94

Morris J, Roberts CL, Levett K, Crowther C. Immediate delivery versus expectant care in women with preterm prelabour rupture of the membranes close to term (PPROMT): a randomised controlled trial. Journal of Paediatrics and Child Health 2008;44:A106

Morris J, Levett K, Roberts C, Crowther C, Henderson-Smart D. Immediate delivery vs expectant management in preterm prelabour rupture of membranes close to term (PPROMT): a randomised trial. PSANZ Melbourne 2007; abstract P61/Journal of Paediatrics and Child Health 2007;43:A123

Morris JM, Roberts CL, Crowther CA, Buchanan SL, Henderson-Smart DJ, Salkeld . Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT) Trial [ISRCTN44485060]. BMC Pregnancy Childbirth 2006;6:9

Buchanan SL. The PPROMT Trial: preterm prelabour rupture of the membranes. PSANZ 2005:A60
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Trial Title Immunogenicity and safety of acellular pertussis vaccine given at birth in healthy infants
ANZCTR ACTRN12609000905268
Status Not yet recruiting
Type Neonatal
Trial Contact NicholW3@chw.edu.au
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Trial Title Improving maternal and child health care for women experiencing violence: collaborative development, implementation and effectiveness of a good practice model
Acronym MOVE
Status Accrual complete
Type Maternal
Trial Contact r.walter@latrobe.edu.au
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Trial Title Improving neurobehavioural development in preterm infants: a randomised controlled trial of a neonatal intervention
Acronym Premie Start
ANZCTR ACTRN012606000412538
NHMRC NHMRC 364902
Status Discontinued
Type Neonatal
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Trial Title Improving oral hygiene to reduce the risk of preterm birth: A randomised controlled trial assessing a high intensity educational intervention
ANZCTR ACTRN012605000767606
Status Not yet recruiting
Type Maternal
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Trial Title Improving the outcome of premature infants – a randomised trial of preventive care at home
NHMRC NHMRC 284512
Status Accrual complete
Type Neonatal
Publications Newnham CA, Milgrom J, Inder TE. Parents as therapists for their preterm infants; optimising development and reducing stress [abstract]. PSANZ 2005: A68
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Trial Title In extremely low birth weight (ELBW) infants who require positive pressure at birth does the Neopuff Infant Resuscitator compared with the Laerdal Infant Bag improve oxygen saturation measurements in the first ten minutes of life?
Acronym Resuscitation Trial
ANZCTR ACTRN012607000062426
NHMRC program grant
Status Accrual complete
Type Neonatal
Publications Schölzer GM, Dawson JA, Kamlin COF, O'Donnell CPF, te Pas AB, Morley CJ, Davis PG. Randomised control trial (RCT) of neopuff vs laerdal-bag for resuscitation of newborn infants: Respiratory function outcomes. J Paediatr Child Health. (2010) 46(Suppl. 1): 40 [abstract A121] Dawson JA, Kamlin COF, tePas AB, Donath SM, O’Donnell CPF, Davis PG, Morley CJ. Neopuff or laerdal self-inflating <29 weeks gestation at birth?: a randomised controlled trial. PSANZ Darwin 2009 abstract A151/Journal of Paediatrics and Child Health 45 (2009);A54

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Trial Title In extremely low birth weight (ELBW) infants who require positive pressure at birth does the use of a respiratory Function Monitor reduce face mask leak and improve the target tidal volume in the first ten minutes of life?
Acronym Florian
ANZCTR ACTRN12608000357358
Status Accrual complete
Type Neonatal
Trial Contact georg.schmoelzer@thewomens.org.au
Publications Schmölzer GM, Dawson JA, Kamlin COF, Hooper S, Morley CJ, Davis PG. A respiratory function monitor during positive pressure ventilation - A randomized trial. J Paediatr Child Health. (2010) 46(Suppl. 1): 85 [abstract P118]
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Trial Title In very preterm infants who are being extubated to nasal continuous positive airway pressure (CPAP), does a continuous positive airway pressure (CPAP) recruitment maneuvre post extubation improve global and regional end-expiratory lung volume, thoracoabdominal asynchrony and work of breathing when compared to no recruitment maneuvre?
Acronym The CPAP Study (Vic)
ANZCTR ACTNR12610000167066
Status Currently recruiting
Type Neonatal
Trial Contact Risha Bhatia: risha.bhatia@thewomens.org.au
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Trial Title Inadvertent dural puncture in labour: Intrathecal catheter versus epidural (The ICE Pilot Study)
Acronym The ICE pilot study
ANZCTR ACTRN12608000009314
Status Discontinued
Type Maternal
Trial Contact matthew.newman@health.sa.gov.au
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Trial Title Infant Cooling Evaluation Trial
Acronym ICE
ANZCTR ACTRN012606000036516
NHMRC NHMRC216725
Other Reference PT0367
Status Stopped early
Type Neonatal
Publications jacobs SE, Stewart M, McNamara P, Wirght I, Kirpalani H, Darlow B, Inder TE, Doule LW, Morley CJ for the ICE Collaboration. The 'ICE' randomised trial of whole body cooling for hypoxic-ischaemic encephalopathy (HIE). J Paediatr Child Health. (2010)46(Suppl1): 50 [abstract A160]

Jacobs SE, Stewart M, McNamara P, Wright I, Kirpalani H, Darlow B, Inder TE, Doyle LW, Morley CJ, for the ICE Collaboration. 'ICE' safety of whole body cooling for hypoxic-ischaemic encephalopathy (HIE) during neonatal retrieval. J Paediatr Child Health. (2010) 46(Suppl. 1): 50 [abstract A159]

Kirpalani H, Barks J, Thorlund K, Guyatt G. Cooling for neonatal hypoxic ischemic encephalopathy: do we have the answer? Pediatrics 2007;120:5

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Trial Title Infant fish oil study
Acronym IFOS
ANZCTR ACTRN012606000281594
Status Accrual complete
Type Neonatal
Trial Contact susanp@ichr@uwa.edu.au
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Trial Title International Neonatal Immunotherapy Study
Acronym INIS
ANZCTR ACTRN012606000273583
NHMRC NHMRC301973
Other Reference PT0373
Status Accrual complete
Type Neonatal
Trial Contact lsebastian@ctc.usyd.edu.au
Web Link http://www.ctc.usyd.edu.au/inis/; http://www.npeu.ox.ac.uk/inis/
Publications Duggal-Beri PA. Consent DVD designed to improve consent uptake to randomised controlled trials in neonatology - a cluster study in the INIS Network. PSANZ 2006:FC17.6.

The INIS Study Collaborative Group. The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial. BMC Pregnancy and Childbirth 2008,8:52

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Trial Title Intravenous oxytocin bolus of 2 units is superior to 5 units during elective caesarean section
Status Study complete
Type Maternal
Trial Contact james_sartain@health.qld.gov.au
Publications Sartain JB, Barry JJ, Howat PW, McCormack DI, Bryant M. Intravenous oxytocin bolus of 2 units is superior to 5 units during elective caesarean section. Br J Anaesth 2008; 101(6);822-6

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Trial Title Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial
Acronym LIMIT
ANZCTR ACTRN12607000161426
NHMRC NHMRC519240
Status Currently recruiting
Type Maternal
Trial Contact andrea.deussen@adelaide.edu.au
Publications Grivell R, Dodd J. A randomised trial to limit weight gain in overweight and obese women during pregnancy: Effects on fetal growth. IMPACT Abstract 18-19 April 2009.
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Trial Title Magnesium Sulphate for pain relief after caesarean birth
Status Study complete
Type Maternal
Web Link http://www.wirf.com.au/
Publications Paech MJ, Magann EF, Doherty DA, Verity LJ, Newnham JP. Does magnesium sulfate reduce the short- and long-term requirements for pain relief after caesarean delivery? A double-blind placebo-controlled trial. Am J Obstet Gynecol 2006;194(6):1596-602; discussion 1602-3.
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Trial Title Making Choices for Childbirth: A randomised controlled trial of a decision-aid for informed birth after caesarean
Status Study complete
Type Maternal
Publications Shorten A, Shorten B, Keogh J, West S, Morris J. Making choices for childbirth: a randomised controlled trial of a decision-aid for informed birth after caesarean. Birth 2005;32(4):252-61

Shorten A. (2005). A 'decison-aid' for making informed choices about birth after caesarean: Results of a Randomised Control Trial. Midwifery Matters; June: 12-14.
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Trial Title Maternal influenza vaccination: Improving uptake and evaluating the persistence of immune responses at delivery
Acronym FluMum
Status Not yet recruiting
Type Maternal
Publications O’Grady K-A, Krause V, Lambert S, Booy R, Nolan T, McVernon J, Lee K, Andrews R. FluMum: Maternal influenza vaccination: improving uptake and evaluating the persistence of immune responses at delivery. IMPACT 18-19 April 2009.
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Trial Title McRoberts manoeuvre or pushing study
Acronym MCMOPS
Other Reference NCT00116246
Status Discontinued
Type Maternal
Trial Contact
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Trial Title Metformin for the Prevention of Gestational Diabetes
Acronym The MPG Trial
ANZCTR ACTRN12610000157077
Status Not yet recruiting
Type Maternal
Trial Contact bill.hague@adelaide.edu.au
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Trial Title Moxibustion for cephalic version: a feasibility study
Acronym MCV Study
ANZCTR ACTRN12609000985280
Status Not yet recruiting
Type Maternal
Trial Contact caroline.smith@uws.edu.au
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Trial Title Nasal versus face mask for multiple-breath washout technique in preterm infants
NHMRC NHMRC PRF 10210 & CDA 404102
Status Study complete
Type Neonatal
Trial Contact sven.schulzke@health.wa.gov.au
Publications Schulzke SM, Deeptha K, Sinhal S, Baldwin DN, Pillow JJ. Nasal versus face mask for multiple-breath washout technique in preterm infants. Pediatr Pulmonol 2008; 43:858-865

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Trial Title Neonatal Inhaled Pentoxifylline for early and delayed treatment of chronic lung disease
Acronym NIP
Other Reference PT0389
Status Suspended
Type Neonatal
Trial Contact jsinn@med.usyd.edu.au
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Trial Title Omega-3 fatty acids as a treatment for perinatal depression: randomized double-blind placebo-controlled trial
Status Study complete
Type Maternal
Trial Contact a.rees@unsw.edu.au
Web Link http://dx.doi.org/10.1080/00048670701827267
Publications Rees Anne-Marie, Austin Marie-Paule, Parker Gordon B. Omega-3 fatty acids as a treatment for perinatal depression: randomized double-blind placebo-controlled trial. Australian and New Zealand Journal of Psychiatry 2008;42(3):199-205
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Trial Title Online cognitive behaviour therapy for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial. MoodGYM
ANZCTR ACTRN12609001032246
Status Not yet recruiting
Type Maternal
Trial Contact bethany.jones@anu.edu.au
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Trial Title Open versus specific questioning to assess pain during anaesthetic follow-up after caesarean birth: a randomised trial
ANZCTR ACTRN12609000121268
Status Accrual complete
Type Maternal
Trial Contact allan.cyna@cywhs.sa.gov.au
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Trial Title Optimisation of the management of placental delivery in second trimester pregnancy interruption
Other Reference NCT00120042
Status Study complete
Type Maternal
Trial Contact c.parker@wombatcollaboration.net
Publications Dickinson JE, Doherty DA. Optimisation of placental management in second trimester medical pregnancy termination. PSANZ Darwin 2009 abstract A134/Journal of Paediatrics and Child Health 45 (2009);A49

Dickinson, JE, Doherty DA. Optimization of third-stage management after second-trimester medical pregnancy termination. Am J Obstet Gynecol 2009;201; Jul 25.

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Trial Title Optimising preterm infant outcomes: a RCT to evaluate two screening & surveillance methods
Acronym OPIO
ANZCTR ACTRN012606000472572
Other Reference PT0518
Status Study complete
Type Neonatal
Publications Pritchard MA. Preterm-targeted primary child health screening and surveillance program for children born very preterm for the early identification of disability: a randomised controlled trial. PSANZ 2006:FC13.8 (139).

Pritchard MA, Colditz PB & Beller EM. (2005). Parents' evaluation of developmental status in children born with a birthweight of 1250g or less. J.Pediatr.Child Health; 41: 191-196.
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Trial Title Optimising the protein and energy content of human milk feeds to improve the growth of preterm infants - A randomised controlled trial
ANZCTR ACTRN12610000443099
Status Not yet recruiting
Type Not Recorded
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Trial Title Oral misoprostol for the induction of labour at term
Acronym MILO
ANZCTR ACTRN012606000156583
Other Reference PT0361
Status Study complete
Type Maternal
Publications Dodd JM, Crowther, CA, Robinson JS. Oral misoprostol for induction of labour at term: randomised controlled trial. BMJ 2006;332:509-13

Dodd, J M Misoprostol for the induction of labour at term: a randomised controlled trial. PSANZ 2005:A169.

Dodd JM, Crowther CA, Robinson JS. Morning compared with evening induction of labor: a nested randomized controlled trial. Obstetrics and Gynecology 2006;108(2):35-60
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Trial Title Oral misoprostol versus intravenous oxytocin for induction of labour following artificial or spontaneous rupture of membranes: a randomised controlled trial
Status Accrual complete
Type Maternal
Publications Dodd JM. Oral misoprostol versus intravenous oxytocin for induction of labour following artificial or spontaneous rupture of membranes: a randomised controlled trial. PSANZ 2006: PS 5.7(258).
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Trial Title Oral oxycodone analgesia compared with intrathecal morphine for pain relief after caesarean delivery: a randomised controlled trial
Acronym SMOOTH study
ANZCTR ACTRN0120606000506594
Status Study complete
Type Maternal
Trial Contact c.parker@wombatcollaboration.net
Publications McDonnell NJ, Paech MJ, Browning RM, Nathan EA. A randomised comparison of regular oral oxycodone and intrathecal morphine for post-caesarean analgesia. Int J of Obstet Anesth (2009), doi;10.1016/j.ijoa.2009.03.004

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Trial Title Outpatient cervical priming for induction of labour
Acronym OPRA
ANZCTR ACTRN12608000249358
NHMRC NHMRC 519236 (2007)
Status Currently recruiting
Type Maternal
Trial Contact chris.wilkinson@cywhs.sa.gov.au
Publications Wilkinson CS, Turnbull DA, Wilson HJ, Khuzikatil VL, Thomas JT. Outpatient cervical priming for induction of labour: a mixed methods investigation to establish the need for and acceptability of a randomised controlled trial [PSANZ 2008 abstract]. Journal of Paediatrics and Child Health 2008;44:A54

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Trial Title Outpatient Foley catheter vs inpatient Prostin gel for induction of labour
ANZCTR ACTRN12609000420246
Status Currently recruiting
Type Maternal
Trial Contact amanda.henry@sesiahs.health.nsw.gov.au
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Trial Title Oxytocin as an adjunct to interaction coaching and baby massage to improve bonding in the early postpartum
ANZCTR ACTRN12609000483257
Status Currently recruiting
Type Maternal
Trial Contact rmcerlean@psy.unsw.edu.au
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Trial Title Parecoxib, celecoxib and paracetamol for pain management following caesarean delivery
Acronym The COMMAND Trial
ANZCTR ACTRN126090001041246
Status Currently recruiting
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
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Trial Title Parenteral intravenous optimal treatment for hypertensive emergencies in pregnancy
Acronym PIVOT
Other Reference PT0388
Status Study complete
Type Maternal
Publications Hennessy A, Thornton CE, Makris A, Ogle RF, Henderson-Smart DJ, Gillin AG, Child A. A randomised comparison of hydrazaline and mini-bolus diazoxide for hypertensive emergencies in pregnancy: the PIVOT trial. Australian and New Zealand Journal of Obstetrics and Gynaecology 2007;47:279-85
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Trial Title Percutaneous Shunting for Lower-Urinary Tract Obstruction
Acronym PLUTO
ISRCTN ISRCTN53328556
Status Currently recruiting
Type Maternal
Trial Contact m.d.kilby@bham.ac.uk
Publications Morris RK, Malin GL, Khan KS, Kilby MD. Antenatal ultrasound to predict postnatal renal function in congenital lower urinary tract obstruction: systematic review of test accuracy. BJOG 2009:116(10);1290-9.

Morris RK, Kilby MD. Review. An overview of the literature on congenital lower urinary tract obstruction and introduction to the PLUTO trial: Percutaneous shunting in lower urinary tract obstruction. Australian and New Zealand Journal of Obstetrics and Gynaecology 2009; 49:6-10.

Whittle M. Does fetal bladder drainage have a role? PLUTO - a trial long overdue. British Journal of Obstetrics and Gynaecology 2007;114:794-5.
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Trial Title Perinatal treatment of depression
ANZCTR ACTRN12609000831280
Status Not yet recruiting
Type Maternal
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Trial Title Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial
Status Study complete
Type Maternal
Publications Dahlen H, Homer C. Perineal trauma and postpartum perineal morbidity in Asian and non-Asian primiparous women giving birth in Australia. J Obstet Gynecol Neonatal Nurs. 2008 Jul-Aug; 37(4):455-63

Dahlen HG, Homer CSE, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery 2009 25, e39-e48

Dahlen H, Homer C. Perineal warm packs: 'old wives' tales' or evidence based practice? Journal of Paediatrics and Child Health 2008;44:A46

Dahlen HG, Homer CSE, Cooke M, Upton A, Nunn R, Brodrick B. Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial. Birth 2007;34(4):282-90

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Trial Title Persistent Occipito-Posterior: Outcomes following digital rotation.
Acronym The POPOUT Study
ANZCTR ACTRN12609000833268
Status Not yet recruiting
Type Maternal
Trial Contact hala.phipps@email.cs.nsw.gov.au
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Trial Title Phototherapy and patency of the Ductus Arteriosus in extremely preterm infants: a randomised trial
Status Stopped early
Type Neonatal
Publications Travadi J, Simmer K, Ramsay J, Doherty D, Hagan R. Patent ductus arteriorus in extremely preterm infants receiving phototherapy: Does shielding the chest make a difference? A randomized, controlled trial. Acta Paediatrica 2006;95:1418-23

Travadi JN, Hagan R, Ramsay J, Simmer K. Phototherapy and patency of the ductus arteriosus in extremely preterm infants: a randomised trial [abstract]. PSANZ 2005:A74
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Trial Title Pneumococcal vaccination of Australian Indigenous mothers to see if it protects their babies from ear disease
Acronym PneuMum
NHMRC NHMRC490320
Other Reference NCT00310349
Status Currently recruiting
Type Maternal
Trial Contact ross.andrews@menzies.edu.au or jane.nelson@menzies.edu.au
Web Link http://www.menzies.edu.au
Publications Wylie F. Closing the gap. [Vaccinations] Clinical Research. Australian Life Scientist, July/August 2009;39-40. www.lifescientist.com.au

Andrews R, Leach AJ, Moberley S, Nelson J, Morris PS, Tang MLK, Torzillo P, Carapetis JR, Mulholland EDK. PneuMum: a trial of maternal pneumococcal vaccination to prevent infant ear disease. IMPACT 18-19 April 2009.
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Trial Title Positioning to improve lung function in preterm infants requiring ventilatory support
ANZCTR ACTRN012605000210572
Status Accrual complete
Type Neonatal
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Trial Title Post partum hypertension risk after non-steroidal analgesic use (excluding paracetamol)
Other Reference PT0522
Status Currently recruiting
Type Maternal
Web Link http://www.preeclampsia.org.au/research/index.htm
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Trial Title Postnatal dexamethasone in tiny babies: does it do more good than harm?
Acronym DART
NHMRC NHMRC108700
Other Reference PT0359
Status Stopped early
Type Neonatal
Publications Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB DART Study Investigators. Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone. Pediatrics 2007;119(4):716-21

Doyle LW, Davis PG, Morley CJ, McPhee A, Carlin JB and the DART Study Investigators. Low-dose dexamethasone facilitates extubation among chronically ventilator-dependent infants: a multicenter, international, randomized, controlled trial. Pediatrics 2006;117:75-83

Doyle LW. Low dose dexamethasone in chronically ventilator-dependent infants and survival free of disability in early childhood. the DART Study - A multicentre international randomised controlled trial. PSANZ 2005:A171.

Doyle LW. Low dose dexamethasone in chronically ventilator-dependent infants and survival free of disability in early childhood. the DART study - a multicentre international randomised controlled trial. PSANZ 2005:P48.
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Trial Title Postnatal perineal pain project
ANZCTR ACTRN12609000555257
Status Accrual complete
Type Maternal
Trial Contact krrickar@nsccahs.health.nsw.gov.au
Publications Hartz D, Morris J, Tracy S, Richard K, Buchanan S. A randomised controlled trial comparing rectal diclofenac with oral diclofenac and oral or rectal paracetamol in primiparous women after childbirth. PSANZ Darwin 2009;abstract A192/Journal of Paediatrics and Child Health 45 (2009) A10-A71.

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Trial Title Prebiotic supplementation of formula in preterm neonates: a systematic review and meta-analysis of randomised controlled trials
Status Currently recruiting
Type Neonatal
Trial Contact sanjay;patole@health.wa.gov.au
Publications Srinivasjois R, Roa S, Patole S. Prebiotic supplementation of formula in preterm neonates: a systematic review and meta-analysis of randomised controlled trials. Clinical Nutrition 2009;28;3: 237-242.

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Trial Title Prediction of normal vaginal delivery
Other Reference PT0547
Status Currently recruiting
Type Maternal
Trial Contact hpdietz@bigpond.com
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Trial Title Pregnancy and Glycaemic Index Outcomes Study comparing a low glycaemic index (GI) diet to a standard healthy diet
Acronym PREGGIO
ANZCTR ACTRN12610000174088
Status Currently recruiting
Type Maternal
Trial Contact Shelly.Chartres@sesiahs.nsw.gov.au
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Trial Title Pregnancy iodine and neurodevelopment in kids
Acronym PINK
ANZCTR ACTRN12610000411044
Status Not yet recruiting
Type Neonatal
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Trial Title Premature Infants in Need of Transfusion
Acronym PINT
Other Reference PT0387; NCT00182390
Status Study complete
Type Neonatal
Publications Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CMT, Clarke MC, Vincer MK, Doyle LW, Roberts RS for the PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics 2009;123;207-13

Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr 2006;149(3):301-7.

Andersen C. Neurodevelopmental outcome of extremely low birth weight (ELBW) infants randomised to high or low blood transfusion thresholds – the PINT Outcome study (PINT-OS) [abstract]. PSANZ 2006: FC3.1 (66)
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Trial Title Preventing diabetes in pregnancy from progressing to type 2 diabetes
ANZCTR ACTRN12610000338066
Status Not yet recruiting
Type Maternal
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Trial Title Preventing excess weight gain and gestational diabetes in overweight and obese pregnancies: a research and education project
Acronym Healthier Lifestyles
ANZCTR ACTRN12608000233325
Status Currently recruiting
Type Maternal
Trial Contact cheryce.harrison@med.monash.edu.au
Publications Pubmed search 11/5/2010 (mk): nil found
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Trial Title Preventing heat loss in the preterm infant < 30 weeks
Status Currently recruiting
Type Neonatal
Trial Contact Jacqueline Smith [JacquelineJ_Smith@health.qld.gov.au]
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Trial Title Prevention of hypothermia in the delivery room for preterm infants <30 weeks gestation
ANZCTR ACTRN12608000212358
Status Currently recruiting
Type Neonatal
Trial Contact jacquelinej_smith@health.qld.gov.au
Publications no publication yet - Aug 2010
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Trial Title Prevention of late onset septicaemia in infants in the neonatal intensive care unit, Mater Mothers’ Hospital
Acronym LOS
Other Reference PT0363
Status Accrual complete
Type Neonatal
Publications Alcock GS, Morris S, Woodgate PG, Cooke LH, Liley HG. Prevention of late onset septicaemia in a neonatal intensive care unit: a randomized controlled trial of two methods of parenteral nutrition line management. PSANZ Melbourne 2007; abstract A41/Journal of Paediatrics and Child Health 2007;43:A29
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Trial Title Prevention of low systemic blood flow and brain injury in very preterm babies using milrinone
Other Reference PT0390
Status Study complete
Type Neonatal
Publications Paradisis M, Evans N, Kluckow M, Osborn D. Randomised trial of milrinone versus placebo for prevention of low systemic blood flow in very preterm infants. J Pediatr 2009, 154: 189-95

Paradisis M, Evans N, Kluckow M, Osborn DA. Randomised trial of milrinone versus placebo for prevention of low systemic blood flow in very preterm infants. PSANZ Melbourne 2007; abstract A113 /Journal of Paediatrics and Child Health 2007;43:A60

Paradisis M, Evans N, Kluckow M, Osborn D, McLachlan AJ. Pilot study of milrinone for low systemic blood flow in very preterm infants. J Pediatr 2006; 148(3):306-13.

Paradisis M, Jiang X, McLachlan AJ, Evans N, Kluckow M, Osborn DA. Population pharmacokinetics and dosing regimen design of milrinone in preterm infants. Arch Dis Child Fetal Neonatal Ed 2007 May;92(3):F204-9

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Trial Title Prevention of preterm birth by treatment of periodontal disease during pregnancy -the Smile Study
Acronym SMILE
NHMRC NHMRC353577
Other Reference NCT00133926
Status Study complete
Type Maternal
Trial Contact c.parker@wombatcollaboration.net
Web Link http://www.wirf.com.au/index.cfm?objectid=AA6C5B26-96BA-5DAE-B41DD8FDB922F499&CFID=1634668&CFTOKEN=2e0d1cc205735222-A439FAF7-96BA-5DAE-B0C013FC1903D97A&jsessionid=3c308410206c6060a616
Publications Treatment of periodontal disease during pregnancy: a randomized controlled trial. Newnham JP, Newnham IA, Ball CM, Wright M, Pennell CE, Swain J, Doherty DA. Obstet Gynecol. 2009 Dec;114(6):1239-48 Newnham JP, Newnham IA, Ball CM, Wright M, Pennell CE, Swain J, Doherty DA. Treatment of periodontal disease in pregnancy and preterm birth (The Smile Study). PSANZ Darwin 2009 abstract PL26/Journal of Paediatrics and Child Health 45 (2009);A10-A71 Doherty DA, Newnham JP, Newnham IA, Ball CM, Wright M, Swain J, Pennell CE. Treatment of periodontal disease during pregnancy may prevent stillbirth but does not prevent preterm birth. PSANZ Darwin 2009 PO36/Journal of Paediatrics and Child Health 45 (2009) A74-A125
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Trial Title Prevention of recurrent pre-eclampsia by folic acid and supplementation in women with hyperhomocysteinaemia
Acronym HOPE
Other Reference PT0362
Status Accrual complete
Type Maternal
Publications Hague B, Dekker G, Crowther C, Robinson J, Odendaal H. (2000). The hope (hyperhomocysteinaemia in pre-eclampisia) trial: prevention of recurrent pre-eclampsia by folic acid supplementation in women with hyperhomocysteinaemia, 12th World Congress of the International Society for the Study of Hypertension in Pregnancy.
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Trial Title Primary prevention study for Type 1 diabetes in children at risk
Acronym TRIGR
Other Reference NCT00179777
Status Follow-up continuing
Type Neonatal
Publications Sorkio S, Cuthbertson D, Barlund S, Reunanen A, Nucci AM, Berseth CL, Koski K, Ormisson A, Savilahti E, Ussitalo U, Ludvigsson J, Becker DJ, Dupre J, Krischer JP, Knip M, Akerblom HK, Virtanen SM; TRIGR Study Group. Breastfeeding patterns of mothers with type 1 diabetes: results from an infant feeding trial. Diabetes Metab Res Rev. 2010 Mar;26(3):206-11

The TRIGR Study Group. Study design of the Trial to Reduce IDDN in the Genetically at Risk (TRIGR). Pediatric Diabetes 2007:8:117-37

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Trial Title Probiotic allergy prevention study
ANZCTR ACTRN012606000280505
Status Study complete
Type Neonatal
Publications Prescott SL, Wiltschut J, Taylor A, Westcott L, Jung W, Currie H, Dunstan JA. Early markers of allergic disease in a primary prevention study using probiotics: 2.5-year follow-up phase. Allergy 2008:63:1481-90

Prescott SL, Wickens K, Westcott L, Jung W, Currie H, Black PN, Stanley TV, Mitchell EA, Fitzharris P, Siebers R, Wu L, Crane J, and the Probiotic Study Group. Supplementation with Lactobacillus rhamnosus or Bifidobacterium lactis probiotics in pregnancy increases cord flood interferon-γ and breast milk transforming growth factor-β and immunoglobin A detection. Clinical and Experimental Allergy 2008:38: 1606-14

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Trial Title Probiotic Eczema Prevention Study
Other Reference CSG Trial No. 36
Status Accrual complete
Type Neonatal
Web Link http://www.rch.org.au/
Publications Lahtinen SJ, Boyle RJ, Kivivuori S, Oppedisana F, Smith KR, Robins-Browne R, Salminen SJ, Tang ML-K. Prenatal probiotic administration can influence Bifidobacterium microbiota development in infants at high risk of allergy. J Allergy Clin Immunol. (2009) Vol 123 No 2. Letters to the Editor. (Side Study)

Boyle RJ, Mah L-J, Chen A, Kivivuori S, Robins-Browne RM, Tang ML-K. Effects of Lactobacillus GG greatment during pregnancy on the development of fetal antigen-specific immune responses. Clinical and Experimental Allergy 2008 (38) 1882-1890 (Side Study)

Boyle RJ, Bath-Hextall FJ, Leonardi-Bee J, Murrell DF, Tang ML. Probiotics for treating eczema. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006135. http://www.ncbi.nlm.nih.gov/pubmed/18843705?
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Trial Title Progesterone After Previous Preterm Birth for the Prevention of Neonatal Respiratory Distress Syndrome
Acronym PROGRESS
ISRCTN ISRCTN20269066
NHMRC NHMRC207744
Other Reference NCT00097110
Status Currently recruiting
Type Maternal
Trial Contact pat.ashwood@adelaide.edu.au
Web Link http://wombatcollaboration.net/modules.php?name=Content&pa=showpage&pid=25
Publications Dodd JM, Crowther CA, McPhee AJ, Flenady V, Robinson JS. Progesterone after previous preterm birth for prevention of neonatal respiratory distress syndrome (PROGRESS): a randomised controlled trial. BMC Pregnancy and Childbirth 2009, 9:6

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Trial Title Program of Resources, Information and Support for Mothers
Acronym PRISM
ISRCTN ISRCTN03464021
NHMRC NHMRC191215
Other Reference PT0523
Status Study complete
Type Maternal
Publications Lumley J, Watson L, Small R, Brown S, Mitchell C, Gunn J. PRISM (Program of Resources, Information and Support for Mothers): a community-randomised trial to reduce depression and improve women's physical health six months after birth [ISRCTN03464021]. BMC Public Health. 2006 Feb 17;6:37.

Lumley J, Small R, Brown S, Watson L, Gunn J, Mitchell C, Dawson W. PRISM (Program of Resources, Information and Support for Mothers) Protocol for a community-randomised trial [ISRCTN03464021]. BMC Public Health 2003; 3 : 36.
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Trial Title Propofol compared to morphine and midazolam for facilitating neonatal intubation: A randomized, controlled trial
ANZCTR ACTRN12608000277347
Status Currently recruiting
Type Neonatal
Trial Contact Pieter_Koorts@health.qld.gov.au
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Trial Title Prospective Randomised Automated versus Mercury blood pressure recordings
Acronym PRAM
ISRCTN NCT00809666
Status Accrual complete
Type Maternal
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Trial Title Providing parents in a neonatal intensive care unit with audiorecordings of their conversations with neonatologists: a randomised trial
Acronym TAPE
ANZCTR ACTRN012606000478516
Status Study complete
Type Neonatal
Publications Koh THHG, Butow PN, Coory M, Budge D, Collie Li-An, Whitehall J, Tattersall MH. Provision of taped conversations with neonatologists to mothers of babies in intensive care: randomised controlled trial. BMJ 2007;334:28
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Trial Title Randomised controlled trial of a decision aid for labour analgesia for primiparous women
ISRCTN ISRCTN52287533
NHMRC NHMRC253635 & 262047
Other Reference PT0534
Status Study complete
Type Maternal
Publications Raynes-Greenow CH, Roberts CL, Nassar N, Trevena L. Do audio-guided decision aids improve outcomes? A randomised controlled trial of an audio-guided decision aid compared with a booklet decision aid for Australian women considering labour analgesia. Health Expectations 2009;12;407-16

Raynes-Greenow CH, Roberts CL, Nassar N, Trevena L, McCaffery K. Providing evidence antenatally to aid women's labour analgesia decision making: an RCT of a decision aid for labour and childbirth analgesia. Journal of Paediatrics and Child Health 2008;44:A49

Roberts CL, Raynes-Greenow CH, Nassar N, Trevena L, McCaffery K. Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533]. BMC Pregnancy Childbirth 2004; 4 (1) : 24.
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Trial Title Randomised controlled trial of headbox oxygen versus CPAP for neonatal respiratory distress in non-tertiary hospitals
Acronym Bubbles for babies
NHMRC NHMRC253790
Other Reference PT0401
Status Study complete
Type Neonatal
Publications Buckmaster AG, Arnolda G, Wright IM, Foster JP, Henderson-Smart DJ. Continuous positive airway pressure therapy for infants with respiratory distress in non tertiary care centres: a randomized, controlled trial. Pediatrics 2007;120(3):509-18

Buckmaster A, Arnolda G, Wright I, Henderson-Smart DJ. The use of CPAP to reduce up transfer of infants with respiratory distress in non-tertiary care centres: a randomised controlled trial. PSANZ Melbourne 2007; abstract A40/Journal of Paediatrics and Child Health 2007;43:A29

Foster J, Bidewell J, Nash J, Spence K, Field K, Buckmaster A, Henderson-Smart. Nurses' workload compared for CPAP and headbox oxygen in the non-tertiary special care nursery. PSANZ Melbourne 2007; abstract A40/Journal of Paediatrics and Child Health 2007;43:A29

Foster J, Bidewell J, Lees S, Buckmaster A, Henderson-Smart D. Parental stress and satisfaction compared for CPAP and headbox oxygen in the non-tertiary special care nursery. PSANZ Melbourne 2007; abstract A40/Journal of Paediatrics and Child Health 2007;43:A29
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Trial Title Randomised double cross over study of assisted control ventilation (A/C) versus intermittent ventilation (IMV) in preterm babies weaning off ventilation
Other Reference PT0366
Status Accrual complete
Type Neonatal
Publications No
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Trial Title Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants
ANZCTR ACTRN12607000152426
Status Follow-up complete
Type Neonatal
Publications Pubs to add...PM
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Trial Title Randomised, double-blind, placebo-controlled trial of aminophylline in infants less than 12 months of age with bronchiolitis who require intensive care, to assess if aminophylline is superior to placebo in reducing the duration of ventilatory support.
ANZCTR ACTRN12608000608369
Status Currently recruiting
Type Neonatal
Trial Contact frank.shann@rch.org.au; carmel.delzoppo@rch.org.au
Publications Pubmed search (MK) 11 May 2010 - nil found.
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Trial Title Randomized controlled trial of prophylactic glycerol suppositories on gastric emptying and feed tolerance in premature infants: The Suppose Trial
Acronym The SUPPOSE Trial
Status Accrual complete
Type Neonatal
Trial Contact Ross.Haslam@cywhs.sa.gov.au
Publications Kochar A, Barnett C, Omari T, Haslam R, Davidson G, Goodchild L, Lontis R. Randomized controlled trial of prophylactic glycerol suppositories on gastric emptying and feed tolerance in premature infants: The Suppose Trial. [abstract]. J Paediatrics and Child Health;44;(2008);A12-A59
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Trial Title Response of premature infants born before 29 weeks gestation to early targeted treatment with indomethacin vs placebo
Acronym DETECT
ANZCTR ACTRN12608000295347
Status Currently recruiting
Type Neonatal
Trial Contact mkluckow@med.usyd.edu.au
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Trial Title Routine neonatal postextubation chest physiotherapy: a randomized controlled trial
Status Stopped early
Type Neonatal
Publications Bagley CE, Gray PH, Tudehope DI, Flenady V, Shearman AD, Lamont A. Routine neonatal postextubation chest physiotherapy: a randomized controlled trial. J Paediatr Child Health (2005) 41, 592-7
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Trial Title Safety and efficacy of pentoxifylline as a treatment for preventing the progression of necrotising enterocolitis in preterm neonates - A randomised, placebo controlled pilot trial (POINT)
Acronym POINT
ANZCTR ACTRN012606000257561
Status Not yet recruiting
Type Neonatal
Trial Contact c.parker@wombatcollaboration.net
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Trial Title Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial
Status Study complete
Type Neonatal
Trial Contact maria.makrides@cywhs.sa.gov.au
Publications Gibson RA, Barclay D, Marshall H, Moulin J, Maire J-C, Makrides M. Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial. British Journal of Nutrition (2009), 101,1706-1713

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Trial Title Selenium status of term infants fed selenium-supplemented formula in a randomized dose-response trial
Status Study complete
Type Neonatal
Publications Daniels L, Gibson RA, Simmer K, Van Dael P, Makrides M. Selenium status of term infants fed selenium-supplemented formula in a randomized dose-response trial. Am J Clin Nutr 2008;88:70-6
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Trial Title Self-management versus usual care for the treatment of mastitis following childbirth
ANZCTR ACTRN12607000438459
Status Stopped early
Type Maternal
Trial Contact mcrepins@bond.edu.au, nsmart@bond.edu.au
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Trial Title Sensitivity training for parents of preterm infants
Other Reference NCT00883974
Status Accrual complete
Type Neonatal
Publications Milgrom J, Newnham C, Anderson PJ, Doyle LW, Gemmill AW, Lee K, Hunt RW, Bear M, Inder T. Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res. 2010 Mar;67(3):330-335

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Trial Title Study evaluating pantoprazole in neonates and preterm infants with GERD
Other Reference NCT00362609
Status Accrual complete
Type Neonatal
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Trial Title Support for ongoing breastfeeding
ANZCTR ACTRN12608000361303
Status Follow-up continuing
Type Maternal
Publications Health professional knowledge of breastfeeding: are the health risks of breastfeeding accurately conveyed by the titles and abstracts of journal articles? Journal of Human Lactation 2009. Smith J, Dunstone M, Elliott-Rudder 25(3), 350-358.
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Trial Title Targeted Delivery Suite Intervention Study. A randomised controlled trial of modes of ventilatory support in preterm babies from point of delivery to the neonatal intensive care unit.
Acronym TARDIS
ANZCTR ACTRN12609000986279
Status Currently recruiting
Type Neonatal
Trial Contact tracym@wahs.nsw.gov.au
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Trial Title Targeting duration of indomethacin treatment to the PDA constrictive response using echocardiography: a randomised controlled trial
Status Accrual complete
Type Neonatal
Publications Browning Caimo K, Evans N, Paradisis M. Targeting duration of indomethacin treatment to the PDA constrictive response using echocardiography: a randomised controlled trial. [abstract]. Journal of Paediatrics and Child Health:44:(2008):A12-A59
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Trial Title Telephone reminders to improve the follow-up rate for neonatal intensive care graduates
Status Accrual complete
Type Neonatal
Publications Ross MJ, Sinn J, Gomez R. The use of telephone reminders to improve the follow-up rate for neonatal intensive care graduates: a randomised controlled trial [abstract]. PSANZ 2006:PS1.4 (203)
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Trial Title The CHIPS trial: Control of Hypertension In Pregnancy Study
Acronym CHIPS
ISRCTN ISRCTN71416914
Status Currently recruiting
Type Maternal
Trial Contact chips@cw.bc.ca
Web Link http://www.utoronto.ca/cmicr/chips/
Publications CHIPS Trial Research Protocol, Version 17 March 2009. http:www.utoronto.ca/cmicr/chips/

CHIPS Trial Research Protocol, Version 02 December 2008.

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Trial Title The Effect of a low glycemic index diet during pregnancy on obstetric outcomes
Status Study complete
Type Maternal
Publications Moses RG, Luebcke M, Davis W, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller J. Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes. American Journal of Clinical Nutrition 2006;84:807-12

Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC. The effect of a low glycemic index diet during pregnancy on obstetric outcomes. The International Association for the Study of Obesity. Abstract Obesity reviews 7 (Suppl. 2)2006:118-352

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Trial Title The effect of intrathecal pethidine on shivering in women having caesarean sections: a prospective randomised controlled trial
ANZCTR ACTRN012605000065695
Status Accrual complete
Type Maternal
Publications No publications in progress; findings presented at ANZCA ASM 2006
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Trial Title The effect of levobupivacaine Wound Infusion, for 24 hours, on postoperative pain after caesarean section - a prospective, randomised, double-blind parallel-group placebo controlled clinical trial
Acronym WIPPET
ANZCTR ACTRN012605000241639
Status Discontinued
Type Maternal
Trial Contact c.parker@wombatcollaboration.net
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Trial Title The effect of sildenafil in preterm infants with evolving chronic lung disease
Other Reference NCT00431418
Status Accrual complete
Type Neonatal
Trial Contact kkonig@mercy.com.au
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Trial Title The effects of antenatal hypnosis on pain relief in labour
Acronym HATCH
ANZCTR ACTRN012605000018617
NHMRC NHMRC453446
Other Reference NCT00282204
Status Accrual complete
Type Maternal
Trial Contact Allan.Cyna@cywhs.sa.gov.au
Publications Cyna AM, Andrew MI, Robinson JS, Crowther CA, Baghurst P, Turnbull D, Wicks G, Whittle. Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204] - protocol. BMC Pregnancy and Childbirth 2006;6:5
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Trial Title The efficacy and feasibility of progressive strength training in the management of glucose control in women with gestational diabetes
ANZCTR ACTRN012605000378628
Status Accrual complete
Type Maternal
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Trial Title The Epi-No Trial: Effect of intravaginal balloon device on levator trauma in mothers following childbirth
Acronym EpiNo
ANZCTR ACTRN12609000592246
Status Currently recruiting
Type Maternal
Trial Contact hpdietz@med.usyd.edu.au
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Trial Title The feasibility and efficacy of an individualised approach to increase physical activity among women with previous gestational diabetes mellitus
Acronym 'Shift your Risk'
ANZCTR ACTRN12608000280303
Status Accrual complete
Type Maternal
Trial Contact david.mcintyre@mater.org.au
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Trial Title The influence of acupuncture on the induction of labour for women with a postdate pregnancy: a randomised controlled trial
ANZCTR ACTNR12606000494538
Other Reference PT0348
Status Study complete
Type Maternal
Publications Smith CA, Crowther CA, Collins CT, Coyle ME. Acupuncture to induce labour: Findings from a randomised controlled trial. PSANZ Darwin 2009 abstract A190/Journal of Paediatrics and Child Health 45 (2009);A65

Smith CA, Crowther CA, Collins CT Coyle ME. Acupuncture to induce labor: a randomised controlled trial. Obstetrics & Gynecology. 2008;112(5):1067-74
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Trial Title The MONT (mask or nasal tube) Trial: A randomised controlled trial of mask versus nasal tube for the stabilisation of preterm infants (born between 24 and 29 complete weeks gestation) in the delivery room
Acronym MONT Trial
ANZCTR ACTRN12610000230055
Status Currently recruiting
Type Not Recorded
Trial Contact Omar Kamlin: omar.kamlin@thewomens.org.au
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Trial Title The non-thermoregulatory effects of incubator humidity on preterm infants
Other Reference PT0541
Status Not yet recruiting
Type Neonatal
Trial Contact lynn_sinclair@wsahs.nsw.gov.au
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Trial Title The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia - a randomised controlled trial
Acronym Bakri
Status Currently recruiting
Type Maternal
Publications no publication yet - Aug 2010
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Trial Title The use of acupressure wristbands to prevent nausea and vomiting in labour and delivery
ANZCTR ACTRN12607000585426
Status Accrual complete
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
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Trial Title The use of probiotics to reduce the incidence of sepsis in premature infants
Acronym ProPrem
ANZCTR ACTRN12607000144415
NHMRC NHMRC454629
Status Currently recruiting
Type Neonatal
Publications Pubmed search 11/5/2010 (mk): nil found
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Trial Title The use of skin conductance monitoring to predict severe hypotension after spinal anaesthesia for elective caesarean section (the MEDSTORM trial)
Acronym MEDSTORM
Status Accrual complete
Type Maternal
Trial Contact michael.paech@health.wa.gov.au
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Trial Title Three model care pathways for postnatal depression
Other Reference NCT01002027
Status Accrual complete
Type Maternal
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Trial Title Thrombophilia in Pregnancy Prophylaxis Study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic women
Acronym TIPPS
ISRCTN ISRCTN87441504
ANZCTR ACTRN12608000446369
Status Currently recruiting
Type Maternal
Trial Contact suzette.coat@adelaide.edu.au
Web Link http://www.healthypregnancy.ca
Publications Rodger MA, Kahn SR, Cranney A, Hodsman A, Kovacs MJ, Clement AM, Lazo-Langner A, Hague WM, for the TIPPS Investigators. Long-term dalteparin in pregnancy for associated with a decrease in bone mineral density: substudy of a randomized controlled trial. J Throm Haemost 2007;5:1600-6

Rodger MA, Kahn S, Cranney A, Hodson A, Kovacs M, Clement AM, Lazo-Langer A, Hague B, Karovitch A, Keely E, Walker M, Robinson S, Blostein M, Smith G, Kingdom J, Demers C, Solymoss S, Khurana R, Rey E, Wells PS. Prophylactic low molecular weight heparin (LMWH) during pregnancy is not associated with a decrease in bone mineral density (BMD): a randomised controlled trial. Hypertension in Pregnancy 2006 Supplement; Vol 25:p8

Abou-Nassar K, Rodger MD, Kovacs MJ, Doucette S, Tim R, Kahn S, Wells P, Robinson KS, Blostein M, Solymoss S, Rey E. The effect of dalteparin on coagulation activation during pregnancy in women with thrombophilia: a randomised trial. Blood (ASH Annual Meeting Abstracts) 2006;108: Abstract 874

Rodger MA, Lazo-Langner A, Kahn S, Kovacs M, Robinson S, Blostein M, Smith G, Kingdom J, Demers C, Solymoss S, Khurana R, Rey E, Clement AM, Wells PS. Prophylactic low molecular weight heparin (LMWH) during pregnancy is not associated with a decrease in bone mineral density (BMD). The TIPPS (Thrombophilia in Pregnancy Prophylaxis Study )BMD substudy. Blood (ASH Annual Meeting Abstracts) 2005;106: Abstract 548

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Trial Title Timing of induction at Term (TILT): a randomised trial
Acronym TILT
Status Not yet recruiting
Type Maternal
Publications Dodd JM, Crowther CA, Robinson JS. Timing of Induction of Labour at Term (TILT): a randomised trial. IMPACT Network meeting, Melbourne, April 2007
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Trial Title Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial
Status Accrual complete
Type Neonatal
Trial Contact julie.bines@rch.org.au
Publications Webb AN, Hardy P, Peterkin M, Lee O, Shalley H, Croft KD, Mori TA, Heine RG, Bines JE. Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial. Nutrition;24;2008;1057-64

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Trial Title Toward Parenthood: delivering an antenatal self-help intervention with telephone support for depression, anxiety and parenting difficulties - facilitating the perinatal health journey
Acronym TPP
ANZCTR ACTRN012606000263594
Status Stopped early
Type Maternal
Publications
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Trial Title Transversus abdominis plane block, performed by an ultrasound or landmark technique, as part of a multimodal analgesic regimen for post caesarean section analgesia: a randomised controlled trial
Status Not yet recruiting
Type Maternal
Trial Contact nolan.mcdonnell@health.wa.gov.au
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Trial Title Trial of Hydrocolloid dressing for preterm babies on nasal bubble CPAP
Status Not yet recruiting
Type Neonatal
Trial Contact dianne.karamujic@mater.org.au
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Trial Title Trial of indomethacin prophylaxis in preterms
Acronym TIPP
Status Study complete
Type Neonatal
Publications Alfaleh K, Smyth JA, Roberts RS, Solimano A, Asztalos EV, Schmidt B and for the Trial of Indomethacin Prophylaxis in Preterm Investigators. Prevention and 18-month outcomes of serious pulmonary hemorrhage in extremely low birth weight infrants: results from the Trial of Indomethacin Prophylaxis in Preterms. Pediatrics 2008;121;e233-8.

Schmidt B, Roberts R, Fanaroff A, Davis P, Kirpalani H, Nwaesei C, Vincer M and the TIPP Investigators (2006). Indomethacin prophylaxis, patent ductus arteriosus and the risk of bronchopulmnary dysplasia: Further analyses from the trial of indomethacin prophylaxis in pretems (TIPP), The Journal of Pediatrics; June:730-34.

Roberts, R. S., Robertson, C. M., Sauve, R. S., Whitfield, M. F., Schmidt, B., Asztalos, E. V. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. Jama 2003; 289 (9) : 1124-9.

Zupancic JAF, Richardson DK, O’Brien BJ, Cronin CG, Schmidt B, Roberts R, Weinstein. Retrospective economic evaluation of a controlled trial of indomethacin prophylaxis for patent ductus arteriosus in premature infants. Early Human Development 2006;82:97-103* *NOTE – Main results of the trial were published in 2001

Schmidt B, Davis P, Moddemann D, Ohlsson A, Roberts RS, Saigal S, Solimano A, Vincer M, Wright L for the Trial of Indomethacin Prophylaxis in Preterms Investigators. Long-term effects of indomethacin prophylaxix in extremely low birth weight infants. N Engl J Med 2001, Vol. 344; 26: 1966-72.

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Trial Title Twin birth study: a multicentred randomised controlled trial comparing planned caesarean section with planned vaginal birth for twins at 32-38 weeks gestation
Acronym TBS
ISRCTN ISRCTN74420086
ANZCTR ACTRN012606000267550
Other Reference PT0540
Status Currently recruiting
Type Maternal
Trial Contact tbs@sw.ca
Web Link www.cmicr.ca/tbs, www.utoronto.ca/miru/tbs
Publications Barrett J. Twin Birth Study (TBS). PSANZ 2006:P78

Barrett J, Hutton E. Twin Birth Study (TBS). PSANZ 2003:P162
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Trial Title TWINS: Timing of Birth at Term- A randomised controlled trial.
Acronym TWINS
ISRCTN ISRCTN15761056
Other Reference PT0426
Status Currently recruiting
Type Maternal
Trial Contact twins@adelaide.edu.au
Web Link http://www.health.adelaide.edu.au/og/research/mpctu.html
Publications Pubmed search 11/5/2010 (mk): nil found
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Trial Title Ultrasound guided transversus abdominis plane (TAP) block for analgesia after caesarean surgery
ANZCTR ACTRN12608000540314
Status Study complete
Type Maternal
Publications Belavy D, Cowlishaw PJ, Howes M, Phillips. Ultrasound-guided transversus abdominis plane block for analgesia after caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. Epub 2009 Aug 22.

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Trial Title Umbilical Arterial Catheterisation Calculation Study
Acronym UACC
Other Reference PT0398
Status Accrual complete
Type Neonatal
Publications Wright IM, Owers M, Wagner M. The umbilical arterial catheter: a formula for improved positioning in the very low birth weight infant. Pediatr Crit Care Med. 2008 Sep;9(5);498-501

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Trial Title Use of chlorhexidine as a topical antiseptic for the prevention of nosocomial infection in premature neonates <29 weeks: a blinded randomised controlled trial
Acronym PICOP
Status Accrual complete
Type Neonatal
Trial Contact sandie@email.cs.nsw.gov.au
Publications
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Trial Title Using the Internet to support breastfeeding duration in regional Western Australia
ANZCTR ACTRN12610000062022
Status Not yet recruiting
Type Maternal
Trial Contact R.Giglia@exchange.curtin.edu.au
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Trial Title Walking versus lying to prevent hypotension following spinal anaesthesia for caesarean section
ANZCTR ACTRN012606000391572
Status Accrual complete
Type Maternal
Trial Contact Allan.Cyna@cywhs.sa.gov.au
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Trial Title Weighing In Pregnancy
Acronym WIP
ANZCTR ACTRN12610000331033
Status Currently recruiting
Type Maternal
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Trial Title What are the effects of different methods of skin and subcutaneous fascia closure on maternal wound complication rates?
Acronym CLOSURE
ANZCTR ACTRN12608000143325
Status Currently recruiting
Type Maternal
Trial Contact rosalie.grivell@adelaide.edu.au
Publications Grivell R, Crowther C, Dodd J. Skin and subcutaneous fascia closure in Caesarean section – a randomised controlled trial. IMPACT 18-19 April 2009.

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Trial Title Which Oxygen saturation level should we use for very premature infants? A randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants
Acronym BOOST II
ANZCTR ACTRN012605000055606
NHMRC NHMRC352386
Status Currently recruiting
Type Neonatal
Trial Contact boost2@ctc.usyd.edu.au
Web Link http://www.ctc.usyd.edu.au/trials/other_trials/boost.htm & http://www.ctc.usyd.edu.au/BoostII/main_body/Home.htm
Publications Mills BA, Davis PG, Clucas LM, Donath SM, Doyle LW. Compliance with pulse oximetry alarm limits: effects of a randomised controlled trial (RCT) of oxygen targeting (BOOST II). Journal of Paediatrics and Child Health 2008;44:A64
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Trial Title Women and the Induction of Labour Dilemma – Trial A
Acronym WILD A
Other Reference PT0519
Status Accrual complete
Type Maternal
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Trial Title Women and the Induction of Labour Dilemma – Trial B
Acronym WILD B
Other Reference PT0520
Status Discontinued
Type Maternal
Publications
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Trial Title Women undergoing combined spinal epidural for elective caesarean section, ondansetron 8mg versus placebo to prevent perioperative shivering
Acronym OSCAR Trial
ANZCTR ACTRN12603000445279
Status Currently recruiting
Type Maternal
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Trial Title Women's Evaluation of Abuse and Violence Care in General Practice: a cluster randomised controlled trial
Acronym WEAVE
ANZCTR ACTRN12608000032358
NHMRC NHMRC 454532
Status Currently recruiting
Type Maternal
Trial Contact weave-team@unimelb.edu.au
Web Link http://www.weave.unimelb.edu.au
Publications Hegarty KL, O’Doherty LJ, Gunn J, Pierce D, Taft AJ. A brief counselling intervention by health professionals utilising the ‘readiness to change’ concept for women experiencing intimate partner abuse: The weave project. Journal of Family Studies. (2008) 14:376-388
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Trial Title Women’s opinions and experiences of prenatal screening for Down Syndrome
Acronym USES
Other Reference PT0355
Status Accrual complete
Type Maternal
Publications No
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Trial Title World Maternal Antifibrinolytic Trial. Tranexamic acid for the treatment of postpartum haemorrhage: an international, randomised, double blind, placebo controlled trial.
Acronym The WOMAN Trial
ISRCTN ISRCTN76912190
Other Reference NCT00872469
Status Not yet recruiting
Type Maternal
Trial Contact thewomantrial@lshtm.ac.uk
Web Link http://www.womantrial.lshtm.ac.uk/
Publications Shakur H, Elbourne D, Gulmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials 2010,11:40

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