| Methods |
Trial conducted in United States, January 2000‐June 2002. |
| Participants |
40 women undergoing second trimester termination of pregnancy following fetal demise. Women were excluded with hypersensitivity to prostaglandins, scarred uterus. |
| Interventions |
Women received vaginal misoprostol (800 mcg) and were then randomised to followed by either vaginal misoprostol (400 mcg at 8‐hourly intervals) or oral misoprostol (400 mcg at 8‐hourly intervals). |
| Outcomes |
Mean induction to birth interval; analgesic requirements (% only), surgical evacuation of the uterus, side effects (% only). |
| Notes |
Method of randomisation: random number table.
Allocation concealment: opaque sealed envelopes.
Blinding of participants, caregivers and outcome assessors: no. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number table. |
| Allocation concealment (selection bias) |
Low risk |
Opaque sealed 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 |
|
