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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. 4-arm trial.
Participants Setting: Edinburgh, UK.
80 women recruited with induction of labour scheduled 72 hrs after recruitment Inclusion criteria: primiparous women aged 18-40, normal viable fetus, 37-41 weeks (confirmed by 1st trimester ultrasound scan), cephalic presentation, Bishop score < 5 Exclusion criteria: women who showed signs of labour onset, placental insufficiency or contraindication to mifepristone,
Interventions Intervention: group 1: (25 women) oral mifepristone 50 mg. Group 2: (25 women) oral mifepristone 200 mg. (In this review we have combined both groups in the analysis although it was not clear how randomisation was achieved in the higher dose study.)
Comparison groups: placebo (2 groups of women 25 compared with the lower dose and 5 with the higher dose. We have combined placebo groups in the analysis in this review as data were reported together in the results in the study reports; group size was very unbalanced for the second part of the study.)
Outcomes Additional induction agents required, labour within 72 hrs, CS, oxytocin augmentation. NICU admission
Notes It was not clear why the placebo group for the higher dose comparison was so small (5 women) or how randomisation was performed to achieve the unbalanced intervention and control groups
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear “Pre-determined randomisation code.”
Allocation concealment? Unclear “Treatment in predetermined numeric order”. It was not clear why the group allocation in the placebo arms of the trial were very unbalanced
Blinding?
Women
Yes “Neither the patient nor the physician had knowledge of whether a simple oral dose of mifepristone or placebo was given.”
Blinding?
Clinical staff
Yes
Blinding?
Outcome assessor
Yes
Incomplete outcome data addressed?
All outcomes
Unclear All women randomised seemed to be accounted for in the analysis, although there was serious imbalance in group size
Free of other bias? Unclear In the second part of the study (higher dose) the treatment to placebo ratio was 1:5. It was not clear how randomisation was performed, or why the control group was so small