| Methods |
Random allocation by computer‐generated, random sequence for sealed opaque envelopes. No placebo use. Outcome assessments were not blinded. |
| Participants |
491 women at low risk for postpartum haemorrhage at Natalspruit Hospital, Johannesburg, South Africa.
Exclusion criteria: not noted. |
| Interventions |
Misoprostol 400 mcg rectally vs ergometrine‐oxytocin 1 ampoule IM. |
| Outcomes |
Blood loss, duration of third stage, side‐effects.
Measurement of blood loss: by estimation. |
| Notes |
Third stage management was active. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"computer‐generated random sequence." |
| Allocation concealment (selection bias) |
Low risk |
"sealed opaque envelopes." |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not clear if blinding occurred. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Loss to follow‐up was minimal for primary outcomes (2‐3%) with the exception of postpartum haemoglobin which was measured in 67% and 65% of women in the misoprostol and ergometrine‐oxytocin groups respectively.
A small number of women (unspecified) allocated to ergometrine‐oxytocin were excluded because of high blood pressure discovered after randomisation. However, results were similar to the whole group when all hypertensives were excluded in a subgroup analysis. |
| Selective reporting (reporting bias) |
Unclear risk |
Not all of the primary outcomes of the review were reported. |
| Other bias |
Low risk |
Baseline variables were comparable between 2 groups except systolic BP during labour. |
