Lelaidier 1994.
Methods | RCT. | |
Participants | Setting: not clear. 32 women. Inclusion criteria: women who had a previous CS with gestational age > 38 and < 42 weeks confirmed by ultrasound. All women were scheduled for induction (21 for "post‐dates", 7 for hypertension and 4 for FGR); Bishop score < 4. |
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Interventions | The study was carried out over a 4 day observation period, induction was planned for the fourth day (PGE₂ and amniotomy or oxytocin induction if Bishop score > 3). Women attended the outpatient's department for NST daily. Intervention group: 200 mg oral mifepristone on days 1 and 2. Comparison group: placebo, same regime as intervention group. |
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Outcomes | CS, assisted birth, uterine scar separation, fetal distress. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "randomisation list" using block design (block size 4). |
Allocation concealment (selection bias) | Low risk | Coded drug boxes. |
Blinding (performance bias and detection bias) Women | Low risk | Described as double‐blind placebo controlled study. "External appearance of the tablets was similar." |
Blinding (performance bias and detection bias) Clinical staff | Low risk | Intervention and placebo tablet described as similar. |
Blinding (performance bias and detection bias) Outcome assessor | Unclear risk | Blinding of outcome assessors not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women appeared to be accounted for in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Outcomes not stated in methods text |
Other bias | Unclear risk | Baseline characteristics similar but no formal test (P value) reported. |