| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
304 women were randomised in a hospital setting in Senegal. 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 who could not give their consent, those requiring a caesarean delivery and those with asthma allergy to misoprostol, pregnancies of less than 36 weeks, temperature above 38°C, chorioamnionitis, multiple pregnancy, severe cardiopathy, severe anaemia, clotting disorders, or complex perineal tear. |
| Interventions |
400 mcg of misoprostol administered orally versus 5 IU of oxytocin administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion' blood loss (mL); change in Hb; diarrhoea; 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) |
Low risk |
A computer‐generated randomised sequence. |
| Allocation concealment (selection bias) |
Low risk |
Cards assigning patients into groups were placed in envelopes which were then sealed and numbered as and when patients were included. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
If an oxytocin drip was used during labour, it was continued for patients in the “oxytocin” group and replaced by a bottle of 5% glucose solution in the “misoprostol” group. The patient was then attended by the midwife who was not informed of the type of uterotonic administered. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The patient was then attended by the midwife who was not informed of the type of uterotonic administered." |
| Objective assessment of blood loss |
Low risk |
The blood lost was collected in a basin placed after the clamping of the umbilical cord and the removal of the amniotic fluid. Episiotomies were repaired immediately after delivery. Blood loss was collected for up to 2 hours after delivery. This blood was transferred into a graduated jar to measure its exact volume. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
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 |
Low risk |
No funding sought for this study. |
