| Methods |
3‐arm active‐controlled double‐dummy randomised trial |
| Participants |
150 women were randomised in a hospital setting in Iran. 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 with any risk factor of postpartum haemorrhage i.e. anaemia (Hb < 8 g/dL), multiple pregnancy, antepartum haemorrhage, polyhydramnios, 2 or more previous caesarean sections and/or a history of previous uterine rupture, cardiac/liver/renal disorders, or known coagulopathy. |
| Interventions |
400 mcg of misoprostol administered sublingually versus 200 mcg plus 5 IU of misoprostol plus oxytocin administered sublingually plus by an IV bolus versus 20 IU of oxytocin administered by an IV infusion |
| Outcomes |
The study recorded the following outcomes: additional uterotonics; change in Hb; 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) |
Unclear risk |
Sequence generation was not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
The study is stated to be double‐blinded but blinding (of study participants and caregivers) was unclear. The study used dummy infusion and tablets but there was no mention of a dummy for the IV bolus that 1 of the groups received. There is insufficient detail reported to decide on the adequacy of the blinding. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
The volume of blood in the suction bottle and blood‐soaked sponges was measured. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data were collected completely from all randomised study participants. |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered prospectively (NCT01571323). |
| 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. |
