Skip to main content
. 2017 Sep 13;2017(9):CD007701. doi: 10.1002/14651858.CD007701.pub3

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.
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.
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.