Mitchell 1993

Methods	2‐arm active‐controlled double‐blinded randomised trial.
Participants	Between dates unspecified in 1984, 461 parturients were randomised in a hospital setting in UK. The population comprised women of unspecified parity, either singleton or multiple 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 significant hypertension or cardiac disease.
Interventions	500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 230) versus 5 IU of oxytocin administered intramuscularly (n = 231).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, manual removal of placenta, blood loss (mL), third‐stage duration (min).
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	Unclear sequence: described as without any blocking or stratification.
Allocation concealment (selection bias)	Low risk	Investigators used identical study boxes prepared by third party (Sandoz).
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study participants and caregivers were blinded to treatment allocations.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded to treatment allocations.
Objective assessment of blood loss	High risk	Investigators evaluated blood loss "in the standard way by graduated jug measurement plus an allowance for spillage."
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	Low risk	The study was supported by funding from the Perinatal Trials Service (public funding), for the Department of Health for England and Wales, and for Birthright (the charitable arm of the RCOG). Coded medication ampoules were provided by Sandoz.