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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 parallel group design.
Participants 120 women attending an antenatal clinic in a hospital in France, 1990-91
Inclusion criteria: termpregnancy scheduled for induction (range of indications), Bishop score < 4
Exclusion criteria: malpresentation, ruptured membranes, multiple pregnancy, > 1 previous CS or known medical condition
Interventions Intervention group: active tablets mifepristone 200 mg. All women received a box with 2 tablets, the first to be taken on the morning of day 1 and the second on the morning of day 2
Comparison group: placebo tablets. Same regimen as intervention group
IOL scheduled for 4 days after intervention, women reported to the hospital each day over the 4 day study period and were asked to report drug reactions, pain, bleeding or contractions
Outcomes Labour within 4-day study period, other induction agents required, duration of labour, mode of birth, Apgar score < 7 at 5 min
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Tablets were supplied by pharmacy according to a “balanced randomisation list”. Block size 4
Allocation concealment? Yes Small block size might mean that allocation order could potentially be anticipated in advance but the drug packs were described as being of similar appearance
Blinding?
Women
Yes Described as a double-blind study.
Blinding?
Clinical staff
Yes Placebo described as being of similar appearance.
Blinding?
Outcome assessor
Yes
Incomplete outcome data addressed?
All outcomes
Unclear 120 women were randomised but 8 were excluded from the results because of a deterioration in their condition within 12 hours of the first pill (3 in the mifepristone group and 5 in the placebo group)
Free of other bias? Unclear Additional induction agents were used for some women so labour and other outcomes may be affected by co-interventions