| Methods |
Random allocation prepared by independent statistician using computer‐generated random numbers with blocked randomisation. Sequentially numbered, sealed, opaque, envelopes used. No placebos used. No blinding of outcome assessments. |
| Participants |
275 women with vaginal delivery in London, UK. Exclusion criteria: < 37 weeks' gestation, < 18 yrs old, multiple gestation, induced labour, asthma, cardiac, renal or hepatic disorder. Study was reported in conjunction with a misoprostol pharmacokinetics trial. |
| Interventions |
Misoprostol 600 mcg orally vs 600 mcg rectally vs 400 mcg rectally. |
| Outcomes |
Side‐effects, clinical estimation of blood loss, duration of third stage, manual removal of placenta. |
| Notes |
"Usual" management of third stage with cord traction.
Blood loss estimated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"computer generated random numbers." |
| Allocation concealment (selection bias) |
Low risk |
"sequentially numbered, sealed, opaque envelopes." |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
The study was not blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No losses to follow‐up or postrandomisation exclusions. |
| Selective reporting (reporting bias) |
Low risk |
Not all of the primary outcomes of the review were reported, however, this study was conducted to analyze the side‐effects of different doses. |
| Other bias |
Low risk |
There was a borderline statistically significant difference between the 2 groups with regard to the maximum plasma concentration. Otherwise the groups were comparable. |
