| Methods |
2‐arm placebo‐controlled randomised trial |
| Participants |
661 women were randomised in a community setting in Guinea‐Bissau. The population comprised women of parity 3 or less, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria were not specified. |
| Interventions |
600 mcg of misoprostol administered sublingually versus placebo |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; manual removal of placenta; death; blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; nausea; vomiting; fever; shivering. |
| Notes |
Contact with study authors for additional information: no. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Using a list of random numbers. |
| Allocation concealment (selection bias) |
Low risk |
Used opaque envelopes that were consecutively‐numbered and filled with the study drugs. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Misoprostol and placebo tablets of identical form, size, colour, and packing were produced". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
After delivery of the baby and drainage of the amniotic fluid, investigators placed a clean plastic‐lined absorbent drape under the mother. They changed the drape as many times as needed. The mother stayed on the drape or was asked to wear a pad over the next 60 minutes. All drapes and pads were weighed with an electronic scale and the known dry weights were subtracted in order to ascertain the volume of blood loss on the basis that 1 g is equivalent to 1 mL. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
| 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 |
Low risk |
The study was supported by funding from the Danish Society of Obstetrics and Gynaecology, the Illum Foundation, and the Danish International Development Agency (public funding). |
