| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
1678 women were randomised in a hospital setting in Pakistan. The population comprised women of any parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with malpresentations such as breech, compound or transverse presentation, multiple pregnancy, placenta praevia type III, IV, placenta accreta, placental abruption, uterine rupture, myomectomy (uterine cavity opened), coagulation disorders, DIC, cardiac diseases, diabetes, and anaemia. |
| Interventions |
800 mcg of misoprostol administered rectally versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; blood loss (mL). |
| 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 |
A lottery method was used. |
| Allocation concealment (selection bias) |
High risk |
Allocation concealment was not reported but unlikely to have been implemented with a lottery method of randomisation. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was unclear. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Unclear risk |
Quote: "Pads soaked were used to asses the amount of blood loss." Methods of evaluating blood loss were not reported in sufficient detail. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Unclear risk |
The authors did not specify whether 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. |
