| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
100 women were randomised in a hospital setting in Equador. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised women with Hb less than 80 g/L, multiple pregnancy, polyhydramnios, previous uterine rupture, bleeding disorders, intrauterine death or hyperthermia (more than 38.5C). |
| Interventions |
400 mcg of misoprostol administered sublingually versus 10 IU of oxytocin administered by an IV infusion |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; blood loss (mL); nausea; vomiting; headache; shivering. |
| 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 randomisation. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Study participants and caregivers were not blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised postoperative blood loss by collection with quote: "suction apparatus and sterile drapes before irrigation" and by weighing the blood collected in abdominal swabs and gauzes with a calibrated scale (Zhongshan Camry Electronic Co Ltd, model EK 4052‐E, Guangdong, China). Investigators estimated the volume of blood loss quote: "by subtraction of amniotic fluid at 30 cc per each centimetre reported by amniotic fluid index". |
| 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. |
