Methods |
computer generated random assignment, open‐label |
Participants |
multicentre trial at 15 sites in the USA, incl. hospitals, non‐profit abortion facilities, private family practice and gynaecologist offices
1168 women, ≤ 63 days pregnant confirmed by ultrasound, without clinical or haematological abnormalities or contraindication to the trial medication |
Interventions |
all women received mifepristone 200mg on day 1
group 1: 800mcg misoprostol/po minimum 24 hours after at home
group 2: misoprostol 800mcg/pv minimum 24 hours after at home |
Outcomes |
complete, incomplete abortion, time to bleeding, side effects |
Notes |
open ‐ labelled study, power calculation to detect a 5 % difference from 95% to 90% efficacy
no hospitalisations and no blood transfusions |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |