Skip to main content
. 2019 Jun 17;2019(6):CD002253. doi: 10.1002/14651858.CD002253.pub4

Lelaidier 1993.

Methods Drug or identical placebo supplied by pharmacy using randomisation list using permutation blocks of 4.
Department of Obstetrics and Gynaecology, Hopital A.Beclere, Clamart, France. Study duration 6 months, no further information.
Participants 46 women with non‐viable pregnancies diagnosed by ultrasound on 2 examinations separated by 1 week. < 14 weeks. No bleeding or pain.
Interventions Mifepristone 600 mg orally (n = 23) or placebo (n = 23). All women were reviewed after 5 days and if miscarriage had not occurred, surgical evacuation was performed that day.
Outcomes Primary outcome was expulsion of the pregnancy. Symptoms also recorded.
Funding No information on funding.
Declarations of interest No information on conflicts of interest.
Notes 2 women in the placebo group underwent surgical evacuation by private practitioners before 5th day review. Both were in the process of miscarriage and were classed as expulsion positive; no information available on symptoms.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: drug or identical placebo supplied by pharmacy using randomisation list using permutation blocks of 4.
Allocation concealment (selection bias) Low risk Comment: identical placebo were used, supplied by pharmacy.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Of the 46 patients included in this trial, two were not included in the results since contradictory advice from private clinicians ended in regular dilatation and aspiration. They both came from the placebo group and were excluded from the denominator when calculating percentages of spontaneous abortion".
Comment: this is not an adequate intention‐to‐treat analysis.
Selective reporting (reporting bias) Low risk Comment: no signs of selective reporting; outcome measures mentioned in the results section were presented in the results section.
Other bias Low risk No other source of bias could be detected
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: ''This study was prospective, randomized and double‐blind".
Comment: adequate blinding by use of identical placebo in control group.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: no specific information on blinding of outcome assessment. Considering that blinding of patients and personnel was adequate, this was probably also done.