Elliott 1998.
Methods | RCT. 4 arm trial. | |
Participants | Setting: Edinburgh, UK. 80 women recruited with IOL scheduled 72 h after recruitment. Inclusion criteria: primiparous women aged 18 to 40 years, normal viable fetus, 37 to 41 weeks (confirmed by first 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 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 h, 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 | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Pre‐determined randomisation code." |
Allocation concealment (selection bias) | Unclear risk | "Treatment in predetermined numeric order." It was not clear why the group allocation in the placebo arms of the trial were very unbalanced. |
Blinding (performance bias and detection bias) Women | Low risk | "Neither the patient nor the physician had knowledge of whether a simple oral dose of mifepristone or placebo was given." |
Blinding (performance bias and detection bias) Clinical staff | Low risk | "Neither the patient nor the physician had knowledge of whether a simple oral dose of mifepristone or placebo was given." |
Blinding (performance bias and detection bias) Outcome assessor | Unclear risk | Blinding of outcome assessors not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All women randomised seemed to be accounted for in the analysis, although there was serious imbalance in group size. |
Selective reporting (reporting bias) | Low risk | Stated outcomes are reported. |
Other bias | Unclear risk | 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. |