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. Author manuscript; available in PMC: 2014 Nov 24.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2
Methods RCT, 2-arm trial.
Participants Setting: not clear.
68 women included,
Inclusion criteria: women with “well-dated” pregnancies with gestational age > 40 weeks and Bishop score < 9
Exclusion criteria: current indication for IOL, malpresentation, multiple pregnancy, previous CS, oligohydramnios (AFI < 5 cm). any contraindication to a trial of labour, current regular contractions
Interventions All women were assessed prior to randomisation.
Intervention group: vaginal misoprostol 25 mcg.
Comparison group: placebo gel.
Fetal and uterine monitoring for 1 hr after treatment then women were discharged home. Labour was induced if BIshop score > 8 after 41 weeks or all women after 42 weeks
Outcomes Uterine hyperstimulation, mode of delivery, epidural, Apgar score, NICU admission. (Women with PROM were given oxytocin to “stimulate labour” but were not included as inductions in the analyses.)
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Computer generated sequence performed in hospital pharmacy.
Allocation concealment? Yes Placebo controlled trial.
Blinding?
Women
Yes Placebo of similar appearance.
Blinding?
Clinical staff
Yes
Incomplete outcome data addressed?
All outcomes
Yes 68 women were randomised, 4 were excluded after randomisation and did not receive the study medication, but were included in an ITT analysis
Free of other bias? Unclear No baseline imbalance apparent.