Methods |
randomly allocated |
Participants |
42 pregnant women, ≤ 49 days of amenorrhoea, confirmed by ultrasound |
Interventions |
all: mifepristone 25mg/twice daily/ for 4 days (=200mg in total) and:
group 1: 1 placebo a.m. and p.m./orally
group 2: PGE2 (minprostin) 1mg/a.m. and placebo /p.m. /orally
group 3: PGE2 1mg/ a.m. and p.m. /orally |
Outcomes |
complete, incomplete abortion
failures, complaints, hormone levels (E2 prostaglandin, beta‐HCG, prolactin)
bleeding pattern |
Notes |
originally planned sample size was 120: study was discontinued due to interim analysis which showed no difference between placebo and PGE2 in the complete abortion rate
no major complications were reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |