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Trial Name Trial ID Main Coordinating Centre
and contact
Status Recruitment Topic Participants Details
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
WASH*T - Effect of transfusion of washed red blood cells on neonatal outcome: a randomised controlled trial ACTRN12613000237785 Women's & Children's Hospital, SA michael.stark@adelaide.edu.au Currently recruiting Transfusion, Immunology and Neonatal Outcomes Infants born with a gestational age up to 28 weeks 6 days clinically requiring a packed red blood cell transfusion transfusion.
MBM - My Baby’s Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy ACTRN12614000291684 Mater Research Institute - The University of Queensland u.chandrasiri@mater.uq.edu.au Not yet recruiting
IMPACT endorsed
Stillbirth prevention. Fetal surveillance. Parental social and emotional wellbeing. Pregnant women without any congenital abnormalities
BBB - Beating the Blues before Birth ACTRN12607000397415 Christopher Holt Recruitment complete Social and emotional wellbeing in pregnancy
Omega-3 fatty acids as a treatment for perinatal depression: randomized double-blind placebo-controlled trial Prince Alfred Hospital/University of New South Wales Recruitment complete Social and emotional wellbeing in pregnancy
The Healthy Start to Pregnancy study - an evaluation of a new early antenatal health promotion model of care for improving maternal health behaviours ACTRN12611000867998 Mater Medical Research Institute Dr Shelley Wilkinson Recruitment complete Social and emotional wellbeing in pregnancy
A family tobacco control program to reduce respiratory illness in Indigenous infants. ACTRN12609000397213 Menzies School of Health Research/Royal Darwin Hospital Vanessa Johnston Recruitment complete Smoking in pregnancy. Indigenous maternal/perinatal health
An RCT of a personal financial incentive (PFI) intervention to reduce antenatal smoking in women receiving public antenatal care ACTRN12612000399897 University of Newcastle, Australia, Assoc Professor Marita Lynagh, Marita.Lynagh@newcastle.edu.au
Recruitment complete Smoking cessation, pregnancy, financial incentives A total of 42 women were recruited to participate in the trial, representing a consent rate of 17%
FIB-UPFRONT PPH - The effect of Upfront Administration of Fibrinogen concentrate on total blood volume loss in Obstetric Haemorrhage ? A Pilot study ACTRN12614000691640 National Women's Health, Auckland City Hospital jayv@adhb.govt.nz Currently recruiting Severe postpartum haemorrahge
Fibrinogen concentrate
ROTEM
Postpartum women with haemorrhage > 1500 mL who meet ROTEM point-of-case testing criteria for treatment with fibrinogen concentrate or placebo
FAST - Comparison of the probability of live birth after elective freezing of all embryos versus standard fresh embryo transfer in patients undergoing in-vitro fertilisation (IVF) ACTRN12616000643471 IVF Australia Southern Sydney, St George Private Hospital, NSW
Dr Christos Venetis
c.venetis@unsw.edu.au
Not yet recruiting Reproductive medicine, IVF fertilisation methods, embryo transfer Women undergoing fertility treatment
The impact of pH on fertilisation in human oocytes ACTRN12617000230358 Westmead Fertility Centre; Westmead Hospital, Westmead NSW 2145
Dr Cecilia Sjoblom
cecilia.sjoblom@sydney.edu.au
Not yet recruiting Reproductive medicine, IVF fertilisation methods Women
Hominax for improving sperm health ACTRN12616000194460 National Institute of Complementary Medicine, Western Sydney University, Campbelltown Campus, Penrith NSW 2751
Prof Caroline Smith
caroline.smith@westernsydney.edu.au
Not yet recruiting Reproductive medicine, infertility, male factor Men undergoing fertility treatment
STREAM - Effect of ovarian stimulation on oocyte quality and embryonic aneuploidy: a prospective, randomised controlled trial ACTRN12616001539426 School of Women’s &amp, Children’s Health, Royal Hospital for Women, NSW 2031
Prof William Ledger
w.ledger@unsw.edu.au
Currently recruiting Reproductive medicine, IVF, ovarian stimulation Women undergoing fertility treatment
NIPA Trial (Nifedipine for improving Implantation and Pregnancy rates in ART) Does nifedipine improve implantation and pregnancy rates in women undergoing in-vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) cycles? ACTRN12617000213347 Melbourne IVF, East Melbourne, VIC, 3002
Dr Alex Polyakov
alex.polyakov@mivf.com.au
Currently recruiting Reproductive medicine, IVF implantation, nifedipine Women
PROVIDE - Impact of Protein IVN on Development: for extremely low birthweight babies, does higher intravenous protein intake in the first 5 days after birth improve neurodevelopmental outcome, growth and body composition through to 2 years of age? ACTRN12612001084875 Liggins Institute, University of Auckland, Barbara Cormack bcormack@adhb.govt.nz Currently recruiting
IMPACT reviewed
Protein, intravenous nutrition, neurodevelopment Birthweight <1000 g
HUMBA - Healthy mUMs and Babies Trial. A four-armed randomised controlled demonstration trial of a multifaceted dietary intervention and probiotic capsules in obese pregnant women in the Counties Manukau Health region ACTRN12615000400561 HUMBA room, Community Midwifery area, Building2, Level 2, 19 Lambie Drive,
Manukau, Auckland Contact: Rennae Taylor, Email: r.taylor@auckland.ac.nz
Currently recruiting Probiotics, Nutritional intervention, Birthweight, Gestational weight gain Non-diabetic obese women with a singleton pregnancy
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
CHiPS Study - Weaning preterm infants with a gestational age (GA) of <30 weeks from respiratory support: a comparison of duration of respiratory support with heated humidified high flow nasal cannula (HHHFNC) and continuous positive airway pressure (CPAP) ACTRN12615000077561 Middlemore Hospital, Counties Manukau DHB, Neonatal Unit, Joanne Clements
joanne.clements@middlemore.co.nz
Currently recruiting Preterm infants
Weaning study
High flow nasal cannula
Continuous positive airway pressure (CPAP)
Infants born at <30 weeks gestational age. Required to have been stable on CPAP 6cmH20 for at least 48 hours are eligible for study
PROTECT - Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomized, controlled trial ACTRN12616000405415 NHMRC Clinical Trial Centre, NSW
protect@ctc.usyd.edu.au

Currently recruiting
IMPACT reviewed
Preterm infant sepsis and inflammation, neurodevelopment Born at less than 29 weeks gestational age with suspected late-onset sepsis or necrotizing enterocolitis
Quad P-twins - Pessary or Progesterone to Prevent Preterm delivery in women with a twin pregnancy and short cervical length ACTRN12616000875404 The University of Adelaide, University Department of Obstetrics and Gynaecology, North Adelaide, SA 5006
Prof Ben Mol
ben.mol@adelaide.edu.au
Not yet recruiting Preterm birth prevention, cervical pessary Pregnant women, twins
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
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
ORIP - Omega-3 fats to reduce the incidence of prematurity ACTRN12613001142729 Women`s and Children`s Health Research Institute, SA (WCH) jo.zhou@adelaide.edu.au Currently recruiting Preterm birth ? prevention and treatment. Maternal nutrition Women at less than 20 weeks' gestation
SMILE Study - Prevention of preterm birth by treatment of periodontal disease during pregnancy NCT00133926/NHMRC353577 ddoherty@obsgyn.uwa.edu.au Recruitment complete Preterm birth ? prevention and treatment
CiPS - Candida in Pregnancy Study - Treatment of candidiasis to prevent preterm birth - pilot study CiPS pilot ACTRN126090001052224 Royal North Shore Recruitment complete Preterm birth ? prevention and treatment
Cervical occlusion in women with cervical insufficiency: randomised, controlled trial with cerclage, with and without cervical occlusion NCT01737788 Recruitment complete Preterm birth ? prevention and treatment
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
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
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
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
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.
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.
PROMISE - The utility of predicting intrapartum fetal compromise at term using fetal cerebro-umbilical ratio and maternal placental growth factor ACTRN12616001009404 Mater Research Institute/University of Queensland, South Brisbane, QLD 4
Prof Sailesh Kumar
sailesh.kumar@mater.uq.edu.au
Not yet recruiting Pregnancy, prediction, intrapartum fetal distress Postnatal women
Efficacy of the Eating4Two smartphone application for the prevention of excessive gestational weight gain ACTRN12617000169347 University of Canberra, Bruce ACT, 2601
Prof Deborah Davis
deborah.davis@canberra.edu.au
Currently recruiting Pregnancy, maternal weight gain, smart phone application Pregnant women
ToBOGM - The Treatment Of BOoking Gestational diabetes Mellitus Study: Evaluating the impact on obstetric outcomes of immediate versus delayed care for gestational diabetes diagnosed at booking ACTRN12616000924459 Western Sydney University, School of Medicine, Campbelltown, NSW 2751
Prof David Simmons
Da.Simmons@westernsydney.edu.au
Not yet recruiting Pregnancy, gestational diabetes Pregnant women
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
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
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
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)
Folic Acid Clinic Trial (FACT) - Effect of folic acid supplementation in pregnancy on pre-eclampsia ISRCTN23781770; NCT01355159 Ottawa Health Research Institute, Ottawa, Canada bill.hague@adelaide.edu.au Recruitment complete Preeclampsia
HOPE Trial - Prevention of recurrent pre-eclampsia by folic acid and supplementation in women with hyperhomocysteinaemia PT0362 William Hague Recruitment complete Preeclampsia
A randomised controlled trial of dark chocolate in pregnancy for reduction in incidence of pre-eclampsia ISRCTN41164968 John James Medical Centre, Australian National University
stephen.robson@anu.edu.au
Recruitment complete Preeclampsia
Post partum haemorrhage (PPH) prevention: oxytocin pharmacokinetics and maternal body mass index (BMI) ACTRN12617000176369 Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Clayton, Victoria 3168
Prof Euan M. Wallace
euan.wallace@monash.edu
Not yet recruiting Postpartum haemorrhage, prevention, pharmacokinetics Birthing women
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
Surgical transversus abdominis plane (TAP) blocks for post-operative pain relief following lower segment caesarean section (LSCS) under spinal anaesthesia ACTRN12617000589381 The Royal Women's Hospital, Victoria 3052
Dr James Griffiths
jamesgriffiths@me.com
Not yet recruiting Post partum, pain management, caesarean section, surgical block Birthing women
Evaluation of physiotherapy management in pregnancy related pelvic girdle pain ACTRN12614000472673 Westmead Hospital, Sydney NSW Australia. Ms Dragana Ceprnja dragana.ceprnja@health.nsw.gov.au Currently recruiting Pelvic girdle pain, physiotherapy Pregnant women with pregnancy related pelvic girdle pain
Parenting from the start: Evaluating a preventative intervention to improve outcomes for first-time mothers and their babies ACTRN12617000321347 School of Psychology, Massey University Manawatu Campus, Palmerston North 4442, New Zealand
Ms Leith Anna Pugmire
l.pugmire@netmail.co.nz
Not yet recruiting Parenting support Pregnant women
Evaluation of the C2u Project - Evaluation of the effectiveness of an infant and family health and wellbeing text message intervention (Connecting 2u) in supporting expectant and new parents ACTRN12616000072415 Children's Health Queensland, South Brisbane, QLD 4101
Ms Cindy Dawson
Cindy.Dawson@health.qld.gov.au
Currently recruiting Parenting support Pregnant women
Oxytocin as an adjunct to interaction coaching and baby massage to improve bonding in the early postpartum ACTRN12609000483257 The University of New South Wales rmcerlean@psy.unsw.edu.au Currently recruiting Parenting
Effectiveness of a modified mother-infant transaction program on outcomes for preterm infants from 3 to 24 months of age carol.newnham@austin.org.au Recruitment complete Parenting