| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
250 women were randomised in a hospital setting in Tunisia. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by both elective or emergency caesarean. Exclusion criteria comprised women undergoing caesarean section with general anaesthesia, or those with placenta praevia, retroplacental clot, multiple pregnancy, premature labour (less than 32 weeks), intrauterine death, Hb less than 80 g/L, coagulopathy, HELLP syndrome, antepartum haemorrhage, ruptured uterus, previous more than 2 caesareans or other uterine scar, prolonged labour (more than 12 hours) or pyrexia. |
| Interventions |
200 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an IV bolus and infusion versus 20 IU of oxytocin administered by an IV bolus + infusion |
| Outcomes |
The study recorded the following outcomes: PPH at 1000; transfusion; blood loss (mL); change in Hb; nausea; vomiting; headache; 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 |
The randomisation was computer‐generated. |
| Allocation concealment (selection bias) |
Low risk |
A slip of paper was placed inside an opaque, sealed envelope. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
High risk |
Investigators appraised perioperative blood loss as a combination of the volume of liquid in the suction collection jar, and the weight of swabs and pads. |
| 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 |
Unclear risk |
Source(s) of funding for the study were not reported. |
