Oral misoprostal for the induction of labour at term
Oral misoprostol versus vaginal prostaglandin E2 for the induction of labour at term (beyond 37 weeks gestation).
The Department of Obstetrics & Gynaecology, The University of Adelaide
738 participants
Mar 30, 2001
Interventional
Conditions
Summary
This is a prospective randomised, double blind, placebo controlled trial comparing vaginal prostaglandins E2 gel with an oral synthetic prostaglandin E2 analogue (misoprostol) in the induction of labour at term. Both agents are thought to be equally effective in inducing labour. The main outcomes assessed in this study will be the rate of caesarean section, the number of women who remain undelivered after 24 hours, and uterine hyperstimulation with associated changes in the fetal heart rate. Women, caregivers and outcome assessors (MILO trial) are blinded. For the timing of induction component, it is not possible for women or caregivers to be blinded.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
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
Locations(1)
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ACTRN12606000156583