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Trial Name Trial ID Main Coordinating Centre
and contact		 Status Recruitment Topic Participants Details
Open versus specific questioning to assess pain during anaesthetic follow-up after caesarean birth: a randomised trial ACTRN12609000121268 Women's & Children's Hospital Allan Cyna Recruitment complete Labour and intrapartum care Women within 72 hour of their caesarean section
NIFTY - A multi-centre randomised double blind placebo controlled trial of nifedipine maintenance tocolysis in fetal fibronectin positive women in threatened preterm labour ACTRN12613000985785 National Women's Health, Auckland Hospital. Dr Emma Parry (Principal Investigator) EmmaP@adhb.govt.nz Recruitment complete Preterm birth ? prevention and treatment Women with threatened preterm labour, a singleton pregnancy, gestational age between 24 and 34 weeks, intact membranes, positive fetal fibronectin test, completed course of corticosteroids
HEPRIN - Heparin for the Prevention of complications related to placental Insufficiency ISRCTN88675588 Mt Sinai Hospital, Professor Jodie Dodd (Principal Investigator) jodie.dodd@adelaide.edu.u Recruitment complete Preeclampsia. Fetal growth Women with significant risk factors for placental insufficiency (low PAPP-A, high AFP, high inhibin, high hCG, medical and obstetric risk factors or abdnormal uterine artery Doppler)
FRUIT-Study - Low-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia ISRCTN87325378 Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam,
Netherlands.
Prof JIP de Vries (Chief Investigator) jip.devries@vumc.nl		 Recruitment complete Preeclampsia. Fetal growth. Maternal medical conditions women with previous pregnancy with hypertensive disease and/or SGA <34 weeks and an inheritable thrombophilia
EPPI Trial - Enoxaparin for the Prevention of Preeclampsia and Intrauterine growth restriction ? a pilot randomised placebo-controlled trial ACTRN12609000699268 Department of Obstetrics and Gynaecology, University of Auckland. Laura Mackay (Trial Manager) laura.mackay@auckland.ac.nz; Dr Katie Groom (Chief Investigator) k.groom@auckland.ac.nz Recruitment complete
IMPACT reviewed
 Fetal growth. Preeclampsia Women with previous pregnancy complicated by early onset preeclampsia or fetal growth restriction
PLUTO - Percutaneous shunting for lower urinary tract obstruction ISRCTN53328556 The Clinical Trials Unit, University of Birmingham. Professor Mark Kilby (Chief Investigator) m.d.kilby@bham.ac.uk Recruitment complete Fetal anomaly women with pregnancy with a male fetus complicated by isolated lower urinary tract obstruction (LUTO)
STRIDER (NZAus)- A randomised placebo-controlled trial of a new therapy (sildenafil) to help growth in severely growth restricted fetuses at very early gestations ACTRN12612000584831 Department of Obstetrics and Gynaecology, University of Auckland Laura Mackay (Trial Manager) laura.mackay@auckland.ac.nz; Dr Katie Groom (Chief Investigator) k.groom@auckland.ac.nz Recruitment complete
IMPACT reviewed
 Fetal growth. Preeclampsia. Pterterm birth - prevention and treatment Women with pregnancies complicated early onset fetal growth restriction. Abdominal circumference ≤3rd centile at 22-28 weeks or EFW <700g at 28-80 weeks
DIAMIND - Diabetes SMS text reminders versus standard care for women who have had gestational diabetes mellitus to increase the rate of oral glucose testing in the postpartum period ACTRN12612000621819 Australian Research Centre for Health of Women & Babies, The University of Adelaide emer.heatley@adelaide.edu.au Recruitment complete Diabetes. Maternal medical conditions Women with GDM in current pregnancy, singleton or twin pregnancy, with access to a mobile phone, postnatal blood glucose that level returned to normal before discharge
ACTOTTAB - Twins: Timing of birth at Term PT0426/ISRCTN15761056 WCH, Adelaide Jodie Dodd Recruitment complete Labour and intrapartum care. Models of care Women with a twin pregnancy at 37 weeks gestation
Improving oral hygiene to reduce the risk of preterm birth: A randomised controlled trial assessing a high intensity educational intervention ACTRN12605000767606 caroline.crowther@adelaide.edu.au Discontinued Preterm birth ? prevention and treatment Women with a singleton pregnancy
BAC - Birth after Caesarean. Planned vaginal birth or planned caesarean section for women at term with a single previous caesarean birth ISRCTN53974531/NHMRC349460 Maternal Perinatal Clinical Trials Unit, Adelaide Women's and Children's
Pat Ashwood		 Recruitment complete Labour and intrapartum care Women with a single prior caesarean presenting in their next pregnancy with a single live fetus in cephalic presentation who have reached 37 weeks gestation, and who don't have a contraindication to a planned VBAC.
Help-seeking for postnatal depression as a major public health problem: A cluster randomised controlled trial of motivational interviewing ACTRN12611000635965 Parent-Infant Research Institute, Austin Health, (03) 9496 4496, piri@austin.org.au
 Recruitment complete Motivational interviewing, postnatal depression Women with a 4-week old baby
MPG Trial - Metformin in the Prevention of Gestational Diabetes ACTRN12610000157077 Women`s and Children`s Hospital, Children`s Youth and Women`s Health Service, North Adelaide suzette.coat@adelaide.edu.au Discontinued Prevention of recurrent Gestational diabetes Women who have had a previous pregnancy affected by GDM
CLOSURE - Skin and subcutaneous fascia closure at caesarean section: a randomised controlled trial ACTRN12608000143325 Discipline of Obstetrics and Gynaecology, Women's and Children's Hospital rosalie.grivell@adelaide.edu.au Recruitment complete Labour and intrapartum care Women undergoing a caesarean section by transverse suprapubic incision
IDEAL - Dietary and Lifestyle advice for women with borderline gestational glucose intolerance ACTRN12607000174482 Australian Research Centre for Health of Women and Babies (ARCH), The University of Adelaide pat.ashwood@adelaide.edu.au Recruitment complete Diabetes. Maternal nutrition Women between 24 weeks 0 days and 34 weeks 6 days gestation with a singleton pregnancy, with a positive OGCT (venous plasma glucose >=7.8 mmol/L) and a normal 75 gram OGTT (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L),
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 ACTRN12608000631303 The University of Adelaide / Women's & Children's Hospital pat.ashwood@adelaide.edu.au Recruitment complete Preterm birth ? improving outcomes (antenatal interventions). Newborn respiratory Women at risk of preterm birth at less than 34 weeks gestation, have a singleton or twin pregnancy and no contraindications to the use of antenatal corticosteroids
IRIS - A randomised clinical trial of different infusion rates of magnesium sulphate given prenatally to women for the prevention of side effects ACTRN12605000765628 Women's and Children's Hospital, SA caroline.crowther@adelaide.edu.au Recruitment complete Preterm birth ? improving outcomes (antenatal interventions) Women at less than 30 weeks gestation where birth is planned or definitely expected within 24 hours.
USES Trial - Women's Opinions and Experiences of Prenatal Screening for Down Syndrome PT0355 caroline.crowther@adelaide.edu.au Recruitment complete Fetal surveillance. Fetal anomaly Women at less than 14 weeks gestation who have not had a dating scan or nuchal translucency screening
HUGS - Early intervention to protect the mother-infant relationship following postnatal depression - a randomised controlled trial ACTRN12612001110875 Parent-Infant Research Institute, Austin Health, (03) 9496 4496, piri@austin.org.au
 Recruitment complete Postnatal depression, mother-infant interaction Women aged 18 years or older with an infant aged 3-9 months and a clinical diagnosis of current major or minor depressive episode
The influence of acupuncture on the induction of labour for women with a post date pregnancy: a randomised controlled trial. PT0348 / ACTRN12606000494538 caroline.smith@uws.edu.au Recruitment complete Labour and intrapartum care Women > or = 41 weeks; singleton pregnancy; cephalic presentation
Oral misoprostol versus intravenous oxytocin for induction of labour following artificial or spontaneous rupture of membranes jodie.dodd@adelaide.edu.au Recruitment complete Labour and intrapartum care Women > or = 41 weeks booked for delivery at Women's and Children's Hospital; singleton pregnancy; cephalic presentation
Twin birth study (TBS): a multicentred randomised controlled trial comparing planned caesarean section with planned vaginal birth for twins at 32-38 weeks gestation PT0540/ISRCTN74420086/ACTRN12606000267550 University of Toronto Dalah Mason Recruitment complete Labour and intrapartum care Twins where twin A is cephalic, gestational age 32-38 weeks, estimated fetal weight 1500-4000g, both twins alive.
ACTORDS - Australasian Collaborative Trial of Repeat Doses of Corticosteroids for the Prevention of Neonatal Respiratory Disease ACTRN12606000318583; PT0349; ISRCTN48656428 Adelaide Women's and Children's
pat.ashwood@adelaide.edu.au		 Recruitment complete Preterm birth improving outcomes (antenatal interventions). Newborn respiratory Singleton, twin or triplet pregnancy at less than 32 weeks gestation; 7 or more days since first corticosteroid treatment, remaining at risk of preterm delivery
A double-blind randomised controlled trial of oxytocin bolus plus placebo infusion versus oxytocin bolus plus oxytocin infusion at elective caesarean section ACTRN12607000631404 Monash Medical Centre joanne.mockler@med.monash.edu.au Discontinued Labour and intrapartum care Singleton pregnancy, gestation 37 - 41 weeks, elective lower segment caesarean section, regional anaesthesia (spinal, epidural, combined spinal epidural (CSE))
MILO - Oral misoprostol for the induction of labour at term PT0361/ACTRN012606000156583 Women's and Children's Hospital , SA jodie.dodd@adelaide.edu.au Recruitment complete Labour and intrapartum care Singleton pregnancy, at a gestational age of 37 weeks or more, planned induction of labour for defined obstetric and medical conditions - prolonged pregnancy, pre-eclampsia, hypertensive disoreders, antepartum haemorrhage (ecluding placenta praevia), oligohydramnios, IUGR, or abnormal glucose tolerance.
PPROMT - Immediate delivery vs expectant care in women with preterm prelabour rupture of the membranes close to term - A randomised clinical trial PT0536/ISRCTN44485060/NHMRC358378 Dept of Obstetrics & Gynaecology, Royal North Shore Hospital ppromt@med.usyd.edu.au Recruitment complete Preterm birth ? improving outcomes (antenatal interventions) Singleton pregnancies, with confirmed ruptured membranes from 34 weeks to 36 weeks and 6 days gestation.
HATCh - The effects of antenatal hypnosis on pain relief in labour ACTRN12605000018617 / NCT00282204 Women's & Children's Hospital Allan Cyna Recruitment complete Labour and intrapartum care Previous hypnosis for childbirth; woman definitely wants an epidurtal or hypnosis; Not singleton live fetus before 34 weeks gestation; Other conditions causing pain; Active psychiatric illness.
TIPPS - Thrombophilia in pregnancy prophylaxis study: a multicentre, multinational, randomised controlled trial of prophylactic low molecular weight heparin in high-risk pregnant thrombophilic women ISRCTN87441504 The University of Ottawa Hospital, Ontario, Canada, Professor Marc Rodger (Chief Investigator). Suzette Coat - Australian Coordinator Recruitment complete Preeclampsia. Fetal growth Pregnant women with thrombophilia at increased risk of venous thromboembolism or with previous placenta mediated pregnancy complication prior to 20 weeks gestation
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 PT0538 / ACTRN12606000357550 WCH Maria Makrides Recruitment complete Maternal nutrition. Maternal medical conditions Pregnant women with anaemia on routine screening test at the end of 2nd trimester
LIMIT - Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: a randomised trial ACTRN12607000161426 Women's and Children's Hospital Andrea Deussen Recruitment complete Obesity. Maternal nutrition Pregnant women with a singleton, live gestation between 10+0 - 20 weeks who are obese or overweight (defined as a body mass index greater that 25kg/m2)
PROGRESS - Australian Collaborative trial of vaginal progesterone for prevention of neonatal respiratory distress syndrome ISRCTN20269066; NHMRC399137 Maternal Perinatal Clinical Trials Unit, Adelaide Women's and Children's Pat Ashwood Recruitment complete Preterm birth ? prevention and treatment. Preterm birth ? improving outcomes (antenatal interventions). Newborn respiratory Pregnant women with a history of prior spontaneous preterm birth at less than 34 weeks gestation
Fetal Middle Cerebral Artery Doppler (MCA) velocimetry to determine the timing of second and subsequent fetal blood transfusions in the treatment of fetal anaemia secondary to red cell alloimmunisation - a randomised controlled trial ACTRN12608000643370 The University of Adelaide, SA jodie.dodd@adelaide.edu.au Recruitment complete Fetal surveillance Pregnant women whose fetus has anaemia secondary to red cell alloimmunisation (due to any red cell antibody alone or in combination) as indicated by the need to have performed a single intra-uterine fetal blood transfusion
Hypnosis for nausea and vomiting in early pregnancy a randomised controlled trial ACTRN12607000127404 Women's and Children's Hospital Alan Cyna alan.cyna@adelaide.edu.au Recruitment complete Maternal medical conditions Pregnant women suffering from nausea and vomiting of pregnancy.
ACTOMgSO4 - Australasian Collaborative Trial of Magnesium Sulphate for the Prevention of Mortality and Cerebral Palsy in Infants Born Very Preterm PT0354/ACTRN012606000252516 Adelaide Women's and Children's caroline.crowther@adelaide.edu.au Recruitment complete Preterm birth ? improving outcomes (antenatal interventions) Pregnant women of gestation less than 30 weeks where delivery is planned or definately expected within 24 hours
Walking versus lying to prevent hypotension following spinal anaesthesia for caesarean section ACTRN12606000391572 allan Cyna Recruitment complete Labour and intrapartum care. Maternal medical conditions Pregnant women having spinal anaesthesia prior to caesarean section
OPRA - Outpatient cervical priming for induction of labour ACTRN12608000249358 Women's and Children's Hospital chrisswilkinson@mac.com Recruitment complete Models of care. Labour and intrapartum care Pregnant women having priming for induction of labour, where induction is clinically indicated, there is no evidence of maternal or fetal compromise and in the opinion of the referring caregiver, outpatient management and monitoring is clinically appropriate
A randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study ACTRN12611000331932 School of Psychology, Deakin University, 221 Burwood Highway, Burwood VIC 3125
Professor Helen Skouteris, Helen.skouteris@deakin.edu.au		 Recruitment complete Gestational weight gain, postpartum weight retention, health coaching Pregnant women (n=262) less than 18 weeks gestation (at recruitment), are 18 years of age or older, English speaking, with a pre-pregnancy BMI > 18.5kg/m2, and have no history of disordered eating or diabetes
PDA Trial - Paracetamol Duct Action: The effect of paracetamol vs placebo on ductal closure in premature infants with a late patent ductus arterious ACTRN12611000741987 Royal North Shore Hospital, NSW Prof Martin Kluckow martin.kluckow.usyd.edu.au Recruitment complete PDA closure, Preterm infant, Paracetamol Population: Preterm infants born <33 weeks gestational age with a persistent PDA who are >4 weeks of postnatal age and tolerating at least 50% enteral feeds.
BBBi - Beating the Blues before Birth (individual treatment) ACTRN12609000926235 Parent-Infant Research Institute, Austin Health, (03) 9496 4496, piri@austin.org.au
 Recruitment complete Antenatal depression, cognitive-behavioural therapy, treatment Participants are women aged 18 years or over who are less than 32 weeks pregnant and who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for either Major Depression, Minor Depression, Adjustment Disorder with depressed mood, or Adjustment Disorder with mixed anxiety and depressed mood.
ACTS - Australasian Collaborative Trial of vitamin C and E supplementation for the prevention of pre-eclampsia ISRCTN00416244/NCT00097110/NHMRC207744 caroline.crowther@adelaide.edu.au Recruitment complete Preeclampsia. Maternal nutrition. Maternal medical conditions Nulliparous women with a singleton pregnancy, between 14-22 weeks gestation, a normal blood pressure
The Colic, Irritability, Reflux, Intolerance and Allergy Study (CIRIAS) ACTRN12612000773831 University of Queensland, South Brisbane,Tracy Harb, t.harb@uq.edu.au Recruitment complete maternal dietary intervention for colic Mothers of fully breastfed infant <4 months of age with colic
PINK - Pregnancy iodine and neurodevelopment in kids ACTRN12610000411044 jo.zhou@adelaide.edu.au Discontinued Iodine, pregnancy, child development Mothers and children
The effects of mindfulness training on maternal stress, depressed mood and present moment awareness: A pilot randomised trial ACTRN12614000523606 Monash University jill.beattie@monash.edu Recruitment complete Mindfulness, Pregnancy, Randomised trial Low risk pregnancy in the second trimester at the start of the intervention; 18 years or older; able to read and speak English; having a planned hospital birth; and who commit to attending all eight sessions.
VITAL Trial - The effects of vitamin D supplementation in infancy on immune development ACTRN12612000787886 Childhood Allergy and Immunology Research, University of Western Australia, Dr Debbie Palmer, Ph: + 61 410 851 607, debbie.palmer@uwa.edu.au
 Recruitment complete Vitamin D, infants, immune development Infants with a family history of allergic disease
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. ACTRN12610000382077 carmel.collins@health.sa.gov.au Recruitment complete Newborn nutrition Infants born less than 33 weeks gestation after one but before five days of commencing any enteral feeds and with parental/guardian consent. Multiple births will be eligible and will be randomised individually. Women providing breast milk for their infant not taking DHA supplements or willing to stop taking supplements for duration study.
DINO trial - Docosahexaenoic acid (DHA) for the improvement of neurodevelopmental outcome in preterm infants PT0424/NHMRC250322/ACTRN12606000327583 Women's and Children's Hospital Suzanne McCusker Recruitment complete Newborn nutrition. Newborn ? developmental Infants born < or = 32 weeks gestation
POPPET - Providing Optimal Protein for Prems via Enteral Tubes. Does increasing the protein content of human milk fortifier improve growth in preterm infants <33 weeks gestation? A randomised controlled trial. ACTRN12611001275954 Women's & Children's Health Research Institute jessica.reid@adelaide.edu.au Recruitment complete Newborn nutrition Infants <33 completed weeks gestation whose mothers intend to provide breast milk
TIGGA - Growth and nutritional status of infants fed formula based on goat milk or cow milk ACTRN12608000047392 Child Nutrition Research Women's & Children's Hospital Jo Zhou Recruitment complete Newborn nutrition Healthy term infants, birth weight >=2.5kg & <=4.75kg, mother is exclusively feeding an infant formula within 2 weeks of birth or plans to exclusively breastfeed for at least 4 months.
PIFI - Parent Infant Feeding Initiative: a study to enhance breastfeeding duration ACTRN12614000605695 Curtin University, Perth, Western Australia. Prof Jane Scott jane.scott@curtin.edu.au Recruitment complete Health promotion/education; Breastfeeding Expectant couples (mothers and fathers)
txt4two - Testing the feasibility of an intervention program to promote healthy nutrition, physical activity and weight gain in pregnant women ACTRN12614000288628 Dr Jane Wilcox, School of Exercise and Nutrition Sciences, Deakin University jwillcox@deakin.edu.au Recruitment complete Gestational weight gain, mHealth, nutrition
 Eligible women were identified at their first hospital antenatal visit to a university-affiliated maternity hospital in Melbourne, Australia. Eligibility criteria included women with a singleton, live gestation between 10+0-17+6 weeks; self-reported pre-pregnancy BMI>25kg/m2; able to speak, read and write English; and owned a mobile phone.