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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000156583 |
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Date of registration:
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03/06/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Oral misoprostal for the induction of labour at term
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Scientific title:
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Oral misoprostol versus vaginal prostaglandin E2 for the induction of labour at term (beyond 37 weeks gestation). |
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Date of first enrolment:
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30/03/2001 |
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Target sample size:
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738 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12606000156583.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Jodie Dodd
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Address:
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Discipline of Obstetrics & Gynaecology, The University of Adelaide
Women's & Children's Hospital
72 King William Road, North Adelaide
SA 5019
Australia |
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Telephone:
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+61 8 81617619 |
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Email:
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jodie.dodd@adelaide.edu.au |
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Affiliation:
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Name:
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Jacki Smith
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Address:
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The Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital (WCH)
72 King William Road
North Adelaide SA 5019
Australia |
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Telephone:
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+61 8 81617619 |
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Email:
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jacki.smith@adelaide.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: Induction planned for non-defined conditions, active labour o, or a favourable cervix, contraindication to vaginal birth, previous uterine surgery, ruptured membranes, parity 5 or more, history of asthma, glaucoma or heart disease, suspected cephalo-pelvic disproportion, abnormal lie, breech presentation, fetal distress/non-reassuring fetal heart trace, multiple pregnancy, intrauterine infection, vasa praevia, placenta praevia, active herpes infection, maternal illness precluding induction of labour, and maternal renal or hepatic failure.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Pregnancy at a gestational age of 37 weeks or more.;
Pregnancy at a gestational age of 37 weeks or more.
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Reproductive Health and Childbirth - Childbirth and postnatal care
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Intervention(s)
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Misoprostol group: oral misoprostol in solution (1mg/ml) 20 mls repeated two hourly to a maxmimum of 12 doses plus placebo vaginal gel treatment. Vaginal prostaglandin group: oral placebo (25mg pyradoxive) following dosing regimen described above plus prostaglandin vaginal gel
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Primary Outcome(s)
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Uterine hyperstimulation with fetal heart rate abnormality[Assessed during induction and labour]
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Caesarean section[Assessed during induction and labour]
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Women undelivered after 24 hours[Assessed during induction and labour]
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Secondary Outcome(s)
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Length of stay (neonatal).[]
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Maternal and neonatal morbidity[Measured up to six weeks postpartum.]
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Admission to Neonatal Intensive Care Unit (NICU).[]
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Secondary ID(s)
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Perinatal Trials Registry: PTR361
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Source(s) of Monetary Support
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Women's and Children's Hospital Research Foundation Project Grant
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Ethics review
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Status: Not approved
Approval date:
Contact:
Women's and Children's Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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