| Methods |
Random allocation sequence, generated centrally. Sequentially‐numbered, identical treatment packs drawn from a treatment pack dispenser. Double blinding achieved by use of double placebos. |
| Participants |
18,530 women expecting vaginal delivery in 9 countries. Countries were Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam.
Exclusion criteria: pyrexia (> 38 degrees C) on admission to labour ward, severe asthma, bleeding disorders, elective caesarean section, no consent. |
| Interventions |
Misoprostol 600 mcg orally + placebo IV/IM, vs oxytocin 10 IU IV/IM + placebo tablets. |
| Outcomes |
Blood loss, shivering, pyrexia, nausea, vomiting, diarrhoea, need for transfusion, manual removal of placenta, exploration under general anaesthesia, hysterectomy, admission to ICU, maternal deaths.
Measurement of blood loss: collected blood poured in standard measuring jar. Small gauze swabs soaked with blood put into measuring jar and included in measurement. Linen weighed in some centres. |
| Notes |
Management of third stage: uterotonics, clamping and cutting of cord immediately after delivery, fundal or suprapubic pressure with cord traction after signs of placental separation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random allocation sequence, generated centrally. |
| Allocation concealment (selection bias) |
Low risk |
Sequentially‐numbered, identical treatment packs drawn from a treatment pack dispenser. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double blinding achieved by use of double placebos. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
50/9264 (0.54%) excluded after randomisation in the misoprostol group, 37 because of an emergency caesarean section, and 13 for loss to follow‐up.
38/9226 (0.41%) excluded after randomisation in the oxytocin group, 34 for emergency caesarean section and 4 lost to follow‐up. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review were reported. |
| Other bias |
Low risk |
The 2 groups were comparable. |
