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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 parallel group design.
Participants 84 women attending a USA hospital between 199 to 2001.
Inclusion criteria: singleton, cephalic presentation, intact membranes, Bishop score of 6 or less, reactive NST
Exclusion criteria: ruptured membranes, Bishop score > 6, contraindication to induction, > 3 contractions in 10 min, uterine scar
Interventions Intervention group: vaginal misoprostol 25 mcg.
Comparison group: intracervical PGE2 gel (dinoprostone) 0.5 mg
Women in both groups were randomised after a reactive NST. After drug administration women had continuous fetal heart rate monitoring for 3hrs with discharge home if clinically stable. Women were asked to return the next day (after 18 hrs) for oxytocin induction if labour was not established
Outcomes Vaginal delivery within 24 or 48 hrs, uterine hyperstimulation, CS, oxytocin required, Apgar score < 7 at 5 min, NICU admission
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Random number table.
Allocation concealment? Yes Opaque sequentially numbered envelopes (not stated whether sealed)
Blinding?
Women
No Blinding women would be feasible but the study was not blinded
Blinding?
Clinical staff
No
Blinding?
Outcome assessor
No
Incomplete outcome data addressed?
All outcomes
Yes 84 women were randomised (42 in each group), 2 women were lost to follow up in the misoprostol group but were included in the denominators
Free of other bias? Yes None apparent.