| Methods |
4‐arm active‐controlled double‐dummy randomised trial |
| Participants |
300 women were randomised in a hospital setting in India. The population comprised women of unspecified parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing augmentation of labour, or those with intrauterine death, antepartum haemorrhage, multiple pregnancy, malpresentation, cardiac disorder, Rhesus‐negative mother, hypertension, Hb less than 70 g/L or hypersensitivity/contraindication to prostaglandins. |
| Interventions |
400 or 600 mcg of misoprostol administered sublingually versus 5 IU of oxytocin administered by an IV bolus versus 200 mcg of ergometrine administered by an IV bolus |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); third stage duration (minutes); fever; 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 |
The drug packets were sealed and coded using a computer‐generated random number chart by the same individual. |
| Allocation concealment (selection bias) |
Unclear risk |
Used sealed drug packets. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study was quote "double‐blind": active treatments and placebo treatments were "identical" and investigators were "thus blinded". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators removed any linen soiled with amniotic fluid, and placed a disposable and absorbent pre‐weighed linen saver sheet with a pre‐weighed polythene bag under the mother to collect blood from the uterine cavity. Any blood clots were expressed from the vagina into the polythene bag, which was then removed and weighed. A fresh pre‐weighed sanitary napkin was applied. Separate swabs were not included in the final calculation (addition of the various gravimetric measurements), that was performed 1 hour after delivery. Quote "The specific gravity of blood being 1.08, the amount of blood lost in mL was equal to the weight in grams". |
| 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 (changes in Hb measurements were unspecified beyond textual summary that quote "all groups showed a slight decrease in mean haemoglobin concentration 24 hours postpartum [maximum decrease of 0.6 g/dL]; however, the difference was not significant [ANOVA, P > 0.05]"). |
| 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. |
