Methods |
2‐arm active‐controlled double‐dummy randomised trial. |
Participants |
Between 2005 and 2006, 200 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria were not specified. |
Interventions |
400 mcg of misoprostol administered sublingually (n = 100) versus 200 mcg of ergometrine administered intramuscularly (n = 100). |
Outcomes |
The study recorded the following outcomes: PPH at 500, additional uterotonics, manual removal of placenta, blood loss (mL), change in Hb level, third‐stage duration (min), nausea, 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) |
Unclear risk |
Randomisation sequence generation was not reported. |
Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
The study was "double‐blind": active treatments and placebo treatments were "identical‐looking." |
Blinding of outcome assessment (detection bias) All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
Objective assessment of blood loss |
Low risk |
Investigators evaluated blood loss "accurately with a specially designed calibrated blood collection drape (BRASS‐V drape)." |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
The study 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 |
It was unclear from the study report 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 |
Unclear risk |
Source(s) of funding for the study were unclear. |