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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000156583

Acronym

MILO

Enrollment

738

Registered

2001-06-03

Start date

2001-03-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results