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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, placebo controlled trial.
Participants Setting: not clear. 36 women.
Inclusion criteria: healthy, nulliparous women, 41 weeks’ gestation and Bishop score < 9
Interventions Intervention group: 2.5 mg intravaginal PGE2, with 2nd dose if labour not established 24 hrs later
Comparison group: placebo gel, with 2nd dose after 24 hrs if labour was not established
Outcomes Change in cervix after 48hrs.
Notes Information from brief abstract.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Described as “randomized”.
Allocation concealment? Unclear No information.
Blinding?
Women
Yes Described as double-blind trial with placebo gel.
Blinding?
Clinical staff
Yes
Blinding?
Outcome assessor
Unclear No information.
Incomplete outcome data addressed?
All outcomes
Unclear Little information on methods. It appeared that all women were available at follow up