WHO 2001 MI200/50.
Methods | computer generated number sequence | |
Participants | multicentre trial, 13 centres: Aberdeen, Chandigarh, Edinburgh, Havana, Hong Kong, Ljubljana, Lusaka, Shanghai, Singapore, Stockholm, Szeged, Tbilisi, Tianjin 1224 women <57 days pregnant inclusion criteria: regular cycles, no hormonal contraception or IUD use before first menses after abortion exclusion criteria: medical contraindication for the study medication, history of thromboembolism, liver disease, pruritus in pregnancy, IUD in situ, breastfeeding, heavy smokers | |
Interventions | group 1: mifepristone 50mg/po and gemeprost 0.5mg/pv on day 3 group 2: mifepristone 50mg/po and gemeprost 1.0mg/pv on day 3 group 3: mifepristone 200mg/po and gemeprost 0.5mg/pv on day 3 group 4: mifepristone 200mg/po and gemeprost 1.0mg/pv on day 3 | |
Outcomes | complete /incomplete/missed abortion, side effects | |
Notes | group 1: was discontinued as interim analysis showed below cut‐off results. no blinding for gemeprost 7 women received blood transfusion (2 group 1, 2 group 2, 1 group 3, 2 group4) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |