| Methods |
Trial conducted in Tunisia, January 2003‐July 2004. |
| Participants |
36 women undergoing termination of pregnancy following both fetal demise or termination of a live fetus. Women excluded if hypersensitive to prostaglandins, more than 1 prior caesarean section, severe asthma, glaucoma, vaginal bleeding, anaemia, blood pressure less than 120/80. |
| Interventions |
Women randomised to vaginal misoprostol (200 mcg at 12‐hourly intervals) or vaginal misoprostol (200 mcg at 12‐hourly intervals) with vaginal nitric oxide donor. |
| Outcomes |
Vaginal birth not achieved in 24 hours; mean induction to delivery interval; side effects (any). |
| Notes |
Method of randomisation: stated to be 'random'.
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) |
Unclear risk |
Stated to be "random". |
| 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 |
|
