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. |
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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. |