| Methods |
Trial conducted in Canada, January 1998‐February 2001. |
| Participants |
240 women with singleton pregnancy undergoing termination of pregnancy for fetal anomaly at 15 to 24 weeks' gestation. Women were excluded if hypersensitivity to prostaglandins, prior classical caesarean section, hysterotomy, active bleeding, severe asthma, severe oligohydramnios, or prelabour ruptured membranes. |
| Interventions |
Women randomised to 1) intra‐amniotic prostaglandin F2alpha and laminaria; 2) oral misoprostol (400 mcg at 4‐hourly intervals); or 3) vaginal misoprostol (400 mcg at 4‐hourly intervals). |
| Outcomes |
Mean induction to delivery interval; surgical evacuation of the uterus; nausea; vomiting; diarrhoea; pyrexia. |
| Notes |
Method of randomisation: computer generated.
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 |
Computer generated. |
| 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 |
|
