| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
500 women were randomised in a hospital setting in Venezuela. The population comprised women of parity 4 or less, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing caesareans, grand multiparous (>= 5), multiple pregnancy, previous caesareans, precipitate labour, anaemia (< 6 g/dL), chorioamnionitis, previous PPH, polyhydramnios, intrauterine fetal death, APH, asthma and hypersensitivity in any of the agents, clotting disorders, renal/liver disorders, epilepsy, hypertension, or those who did not consent to the study. |
| Interventions |
600 mcg of misoprostol administered rectally versus 20 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; death; blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; nausea; vomiting; headache; 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 |
The numbers for the assignment to each treatment group were generated with a table of random numbers. |
| Allocation concealment (selection bias) |
Unclear risk |
A sealed system was used that contained the location of each patient to the treatment groups. The envelopes were opened at the beginning of each treatment. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was unclear. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
The blood lost was collected in a calibrated and all the gauzes used were weighed. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
500 women were randomised in the study, but 108 were excluded because of missing data after randomisation. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
High risk |
Those who were excluded from the study after randomisation were not included in the analysis. |
| Funding source |
Unclear risk |
Source(s) of funding for the study were not reported. |
