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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: 43 women attending antenatal clinics in California, USA
Inclusion criteria: women with “post-dates” pregnancies (gestational age > 41 weeks and 6 days based on reliable menstrual history and early ultrasound confirmation) with reactive NST
Exclusion criteria: contraindications to prostaglandins.
Interventions Intervention group: intracervical PGE2 0.5 mg.
Comparison group: visually identical placebo gel.
Women in both groups were observed for 1 hr with external fetal monitoring and then discharged home
Outcomes Bishop score on admission, mode of delivery, interval to delivery, length of labour, infant birthweight and Apgar score
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes External sequence generation by hospital pharmacy.
Allocation concealment? Yes Coded syringes of identical appearance were dispensed from pharmacy
Blinding?
Women
Yes Placebo controlled trial.
Blinding?
Clinical staff
Yes
Blinding?
Outcome assessor
Unclear Not clear when code was revealed.
Incomplete outcome data addressed?
All outcomes
Yes All women randomised appeared to be included in the analyses
Free of other bias? Yes No other bias apparent.