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, |
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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.) |
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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 |