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. 2018 Apr 25;2018(4):CD011689. doi: 10.1002/14651858.CD011689.pub2
Methods 3‐arm active‐controlled randomised trial.
Participants Over 10 months between dates unspecified, 200 parturients 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 parturients with grand multiparity (more than 4), multiple pregnancy, preterm labour (less than 32 weeks), HELLP syndrome, polyhydramnios, coagulopathy, asthma, cardiac/renal disorder, epilepsy, hypertension, Hb less than 80 g/L or known drug allergy.
Interventions 400 mcg of misoprostol administered sublingually (n = 66) versus 200 mcg of ergometrine administered intramuscularly (n = 67).
Outcomes The study recorded the following outcomes: PPH at 500, Additional uterotonics, transfusion, manual removal of placenta, nausea, vomiting, fever, shivering, abdominal pain.
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 Treatment was allocated by a computer‐generated random number.
Allocation concealment (selection bias) Unclear risk Allocation concealment was not reported.
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 After the drainage of amniotic fluid, investigators evaluated blood loss by collection with a sterile calibrated BRASS‐V drape placed under the mother. The drape remained in place for 1 hour. Furthermore, "blood loss in gauze pieces was calculated by subtracting the weight of dry gauze from the weight of blood‐soaked gauze pieces."
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.
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.