Ezeama 2014

Methods	2‐arm active‐controlled double‐dummy randomised trial.
Participants	Between 1st September 2011 and 31st May 2012, 300 parturients were randomised in a hospital setting in Nigeria. 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 caesarean section, or those with premature labour (less than 28 weeks), multiple pregnancy, antepartum haemorrhage, hypertension in pregnancy, severe anaemia or haemoglobinopathy.
Interventions	10 IU of oxytocin administered intramuscularly (n = 151) versus 500 mcg of ergometrine administered intramuscularly (n = 149).
Outcomes	The study recorded the following outcomes: PPH at 500, additional uterotonics, transfusion, manual removal of placenta, blood loss (mL), third‐stage duration (min), nausea, vomiting, hypertension, headache.
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	Randomisation was achieved using computer‐generated random tables.
Allocation concealment (selection bias)	Low risk	A person uninvolved with the study prepared the study drugs. The labels on the ampoules (which were similar in size and colour) were removed and the ampoules were placed in opaque sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"A person uninvolved with the study prepared the study drugs… The labels on the ampoules (which were similar in size and colour) were removed and the ampoules were placed in opaque sealed envelopes, such that only the computer‐generated randomisation numbers on the envelopes were available to identify the study drug during unblinding."
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 fresh large perineal pad with plastic backing." They placed all the gauzes and perineal pads used to absorb the blood into a polythene bag, and subtracted the dry weight from the wet weight. Volume of blood loss was calculated 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)	Low risk	The study protocol was registered (PACTR 201105000292708).
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 institution of the authors.