| Methods |
2‐arm placebo‐controlled randomised trial |
| Participants |
65 women were randomised in a Hospital setting in Switzerland. The population comprised women of unspecified parity, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing caesarean section, or those with multiple pregnancy, pre‐eclampsia, previous PPH or antepartum haemorrhage. |
| Interventions |
600 mcg of misoprostol administered orally versus placebo |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; blood loss (mL); third stage duration (minute); NNU admissions; shivering. |
| 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 |
Generated by random tables. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation performed by pharmacy. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study was quote "double‐masked": "for proper masking, the study drugs were prepared by the hospital pharmacy as three identical gelatine capsules". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
High risk |
Investigators appraised blood loss by the estimation of attending physicians. |
| 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, but not all of the outcomes projected by methodological descriptions were reported as results in the study report. |
| 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. |
