Methods |
Trial conducted in France, December 1999‐September 2000. |
Participants |
90 women undergoing termination of pregnancy following both fetal demise or termination of a live fetus. Women excluded if scarred uterus, vaginal bleeding, cervical dilation more than 2 cm on admission. |
Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) or vaginal misoprostol (200 mcg at 12‐hourly intervals) with oxytocin. |
Outcomes |
Vaginal birth not achieved in 24 hours (% only); mean induction to birth interval; surgical evacuation of uterus; vomiting; diarrhoea; pyrexia. |
Notes |
Method of randomisation: random number table.
Allocation concealment: not stated.
Blinding of participants, caregivers or 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) |
Unclear risk |
Not stated. |
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 |
|