Methods |
randomly allocated
10/261 post‐randomisation exclusions:
2: cycle length < 25 days
6: > 49 days pregnant
1: pregnancy not confirmed
1: wrongly randomised
1 woman was lost to follow‐up (group 2) |
Participants |
Multicentre, Hospitals in Aberdeen, Milan, New Delhi, Shanghai, Singapore, Stockholm, Szeged
261 pregnant women, ≤ 35 years,
≤ 49 days of amenorrhoea confirmed by ultrasound and beta‐HCG if US inconclusive
inclusion criteria:
regular cycles (25‐35 days) for last 3 months
exclusion criteria: unsure about dates, intrauterine device in situ, hormonal contraception during last cycle and intention to start hormonal contraception before first period after abortion |
Interventions |
group 1: mifepristone 25mg/twice daily for 3 days and sulprostone0.25 mg /intramuscular/ on third day a.m.
group 2: mifepristone 25mg /twice daily for 4 days and sulprostone0.25 mg /intramuscular/ on fourth day a.m. |
Outcomes |
complete, and incomplete abortion
failure (intact amniotic sac on follow‐up at 2 weeks)
undetermined outcome
hormone levels (beta‐HCG, estradiol, prolactin, cortisol, prostaglandin) |
Notes |
2 women received blood transfusion; not mentioned which group |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |