| Methods |
2‐arm placebo‐controlled randomised trial |
| Participants |
352 women were randomised in a hospital setting in the USA. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at high risk for PPH, who delivered by both elective or emergency caesarean. Exclusion criteria were not specified. |
| Interventions |
200 mcg plus 20 IU of misoprostol plus oxytocin administered sublingually plus by an IV infusion versus 20 IU of oxytocin administered by an IV infusion |
| Outcomes |
The study recorded the following outcomes: PPH at 1000; additional uterotonics; transfusion; blood loss (mL); change in Hb |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Sequence generation was not reported. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The group assignments were available only to the pharmacy. The nurse selected an opaque vial from the drug cabinet that contained either a 200‐mg misoprostol tablet or placebo. The vial number (which had been assigned in the pharmacy) and patient identification were sent to the pharmacy." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Study participants and caregivers were blinded to treatment allocations. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Unclear risk |
Methods of appraising blood loss were not reported. |
| 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 unclear. |
