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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.
Participants Setting: 91 women with prolonged pregnancy (gestational age > 41 weeks) attending a Florida, USA hospital
Inclusion criteria: uncomplicated pregnancy, reliable dating, Bishop score < 9, reactive NST and ultrasound
Exclusion criteria: vaginal bleeding, ruptured membranes, macrosomia (estimated fetal weight > 4500 g) previous uterine surgery or stillbirth, abnormal FHR or ultrasound, regular contractions
Interventions Intervention group: daily self-administered vaginal PGE2 2mg before bed (women were given instructions re placement and storage of suppositories)
Comparison group: self-administered placebo.
Telephone contact available 24 hrs per day for both groups. Twice weekly clinic attendance for post-dates surveillance (NST and AFV); induction if indicated or at 44 weeks
Outcomes CS rates, chorioamnionitis, Apgar score at 5 min, NICU admission
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Computer generated.
Allocation concealment? Yes Coded drug boxes.
Blinding?
Women
Yes Described as “double blind” placebo controlled.
Blinding?
Clinical staff
Yes
Incomplete outcome data addressed?
All outcomes
Unclear 91 were enrolled but 11 were lost to follow up (3 were excluded as they were non compliant)