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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. 3-arm trial.
Participants Setting: California, USA, women attending a naval medical centre
70 women included in the analysis (2 of 3 treatment arms included, total recruited 105 women)
Inclusion criteria: women with “post dates” pregnancy - gestational age 41 weeks confirmed by menstrual dates and pre-20 weeks ultrasound. Uncomplicated pregnancy. Bishop score < 5
Exclusion criteria: women with any contraindication to vaginal delivery
Interventions (1 intervention group had daily membrane stripping; this group has not been included in the analysis in this review.)
Intervention group: intracervical PGE2 0.5 mg, daily for 3 days
Comparison group: gentle cervical examination, daily for 3 days
Women were instructed to return to hospital is they had bleeding, membrane rupture, regular contractions of reduction in fetal movements. Once Bishop score = 8 or women reached 42 weeks they were admitted to hospital for induction
Outcomes Induced at 42 weeks, CS, instrumental delivery. Apgar score < 7 at 5 min, admission to NICU
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Random number tables.
Allocation concealment? Yes Sealed, opaque, sequentially numbered envelopes.
Blinding?
Women
No Not feasible.
Blinding?
Clinical staff
No
Blinding?
Outcome assessor
Unclear Outcome assessment of cervical changes were reported to be blind
Incomplete outcome data addressed?
All outcomes
Yes No apparent loss to follow up.