| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
530 women were randomised in a hospital setting in India. The population comprised women of parity 4 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing augmentation of labour, caesarean section or instrumental delivery, or those with risk factors for PPH, including BMI more than 30, grand multiparity (5 or more), polyhydramnios, fetal macrosomia, antepartum haemorrhage, prolonged labour, previous PPH, Hb less than 80 g/L, severe pre‐eclampsia, asthma or coagulopathy. |
| Interventions |
400 mcg of misoprostol administered sublingually versus 10 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; death. Blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; nausea; vomiting; fever; shivering. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number sequence. |
| Allocation concealment (selection bias) |
Low risk |
Used pre‐prepared sealed and opaque packet. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The misoprostol and placebo tablets were similar in size, shape, and colour. The ampoules of oxytocin and placebo were also similar. Selection, enrolment, and randomisation were done by the resident doctors, whereas preparation of packets and confidential record maintenance was done by the labour room nursing staff in charge." |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Quote: "Investigators appraised blood loss by collection with specially designed, pre‐weighed absorbent thick cotton pads with plastic lining, placed under the mother. Blood clots, if any, were expressed from the vagina into a polythene bag. Any episiotomy wound was repaired immediately, and the swabs used for the purpose of episiotomy were not included in blood loss assessment. If necessary, pads were replaced during the observational hour after delivery. Then the soaked pad(s) and the blood clots were weighed. "The specific gravity of blood being 1.08, the amount of blood lost in mL was approximately equal to the weight in g". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "2 women in the study group and 1 woman in the control group refused sublingual administration of the drug". |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered (CTRI 2009/091/000672). |
| 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. |
