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. 2018 Apr 25;2018(4):CD011689. doi: 10.1002/14651858.CD011689.pub2
Methods 2‐arm active‐controlled double‐blinded randomised trial.
Participants Between dates unspecified, 200 parturients were randomised in a hospital setting in India. The population comprised women of unspecified parity, unspecified whether singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria were not specified.
Interventions 600 mcg of misoprostol administered rectally (n = 100) versus 10 IU of oxytocin administered intramuscularly (n = 100).
Outcomes The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, 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: no. Additional data from authors: no.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was achieved using computer‐generated random tables.
Allocation concealment (selection bias) Unclear risk A sealed envelope with a code number was opened when vaginal delivery was imminent. The code was not broken till the end of the study.
Blinding of participants and personnel (performance bias) All outcomes Low risk The study was "double‐blind." "Each envelope contained either 3 tablets of 200 mcg misoprostol and an ampoule of normal saline or 3 identical looking placebo tablets and an ampoule of 10 IU oxytocin."
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 by collection with a BRASS‐V calibrated drape placed under the mother. Pre‐weighed gauzes were used to clean any perineal tears or episiotomy. After 1 hour the dry weight of the sponges was subtracted from the soiled weight, and added to the volume of blood collected in the drape on the basis that 1 g is equivalent to 1 mL.
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.