| Methods |
Trial conducted in United States, January 2002‐January 2003. |
| Participants |
60 women undergoing second trimester termination for fetal anomalies or following intrauterine fetal death; trial stopped after 18 women recruited due to poor recruitment rates. Women were excluded if prior caesarean section, myomectomy, renal failure, severe asthma. |
| Interventions |
Women randomised to mifepristone followed by vaginal misoprostol (800 mcg) followed by oral misoprostol (400 mcg 3‐hourly intervals) or surgical dilation and evacuation. |
| Outcomes |
Nausea; vomiting; diarrhoea; median maternal satisfaction. |
| Notes |
Method of randomisation: computer‐generated random number table.
Allocation concealment: sealed opaque envelopes.
Blinding of participants, caregivers or outcome assessors: no. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number table. |
| Allocation concealment (selection bias) |
Low risk |
Sealed opaque envelopes. |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Low risk |
|
