| Methods |
2‐arm placebo‐controlled randomised trial |
| Participants |
550 women were randomised in a hospital setting in South Africa. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria were not specified. |
| Interventions |
400 mcg of misoprostol administered rectally versus placebo |
| Outcomes |
The study recorded the following outcomes: PPH at 1000; additional uterotonics; manual removal of placenta; third stage duration (minutes); diarrhoea; vomiting; shivering; abdominal pain. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| 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 |
Allocation concealment was by means of sealed, opaque containers containing 400 mg misoprostol or placebo tablets. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "The placebo tablets were similar in size and colour but were not identical in shape to the misoprostol tablets. Blinding of the midwife administering the tablets was therefore not possible". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by collection with an absorbent plastic‐backed linen saver and a low‐profile plastic “fracture” bedpan placed under the mother. Blood collection in the plastic bedpan continued until 1 hour after delivery of the baby. At 1 hour after delivery, all the blood on the linen saver was scooped into the bedpan with the blood already collected there, and quote: "the total blood was carefully measured". All the used linen savers and vaginal pads were weighed, and the known dry weights of these materials were subtracted from the measured total weight. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "Records of 4 of the 550 allocations (all from the placebo group) could not be traced". |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Low risk |
All those who were enrolled and randomly allocated to treatment were included in the analysis, in the groups to which they were randomised. |
| Funding source |
Unclear risk |
Source(s) of funding for the study were not reported. |
