| Methods | 3‐arm controlled randomised trial. | |
| Participants | Between November 1999 and June 2000, 602 parturients were randomised in a hospital setting in France. 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 parturients undergoing caesarean section, or those with gestational age less than 32 weeks, previous PPH, intrauterine fetal death, previous uterine scar, multiple pregnancy or pre‐eclampsia. | |
| Interventions | Placebo or control (n = 220) versus 2.5 IU of oxytocin (n = 196) administered intramuscularly versus 600 mcg of misoprostol administered orally (n = 186). | |
| Outcomes | The study recorded the following outcomes: PPH at 500, PPH at 1000, blood loss (mL), change in Hb level, 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) | Low risk | Slips with the words “control,” “Syntocinon,” and “Cytotec” were placed into envelopes which were then drawn at random upon admission into the delivery room to determine to which group the woman would belong. |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported. |
| 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 | Low risk | Investigators evaluated blood loss by weighing (methods of collecting blood 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 not reported. |