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. 2018 Apr 25;2018(4):CD011689. doi: 10.1002/14651858.CD011689.pub2
Methods 2‐arm active‐controlled randomised trial.
Participants Between dates unspecified, 200 parturients were randomised in a hospital setting in India. 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 parturients undergoing elective caesarean section, or those with pre‐term labour (less than 32 weeks), prolonged labour, antepartum haemorrhage, pre‐eclampsia, intrauterine death, multiple pregnancy, epilepsy, asthma, cardiac/kidney disorder, coagulopathy or anaemia.
Interventions 400 mcg of misoprostol administered orally (n = 100) versus an unspecified dose of ergometrine administered by an unspecified injectable method (n = 100).
Outcomes The study recorded the following outcomes: additional uterotonics, transfusion, manual removal of placenta, hypertension.
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 Unclear risk Study participants and caregivers were blinded to treatment allocations.
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Assessor blinding was not reported.
Objective assessment of blood loss Unclear risk Investigators evaluated blood loss in the first 2 hours after delivery of the placenta, by "clinical estimation." However, blood loss data were not reported in a format that could be extracted for the purpose of this review.
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, but not all of the outcomes projected by methodological descriptions were reported as results in the study report.
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 Unclear risk Source(s) of funding for the study were not reported.