Khan 1995

Methods	2‐arm active‐controlled double‐blinded randomised trial.
Participants	Between 1st January 1991 and 30th June 1991, 2040 parturients were randomised in a hospital setting in United Arab Emirates. 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 induction or augmentation of labour, caesarean section or instrumental delivery, or requiring general anaesthesia, epidural or diazepam, or those with antenatal hypertension (160/100 mmHg or more), hypertension on antihypertensive drugs, multiple pregnancy, cardiac disease or Hb of 90 g/L or less.
Interventions	10 IU of oxytocin administered intramuscularly (n = 1017) versus 500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 1023).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, transfusion, manual removal of placenta, vomiting, 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)	Unclear risk	Treatment was allocated as per a number code generated by the hospital pharmacist who alone was aware of the content of the ampoules.
Allocation concealment (selection bias)	Low risk	Participants were assigned an opaque sealed envelope. Each envelope carried the instruction to use a numbered vial of the study drug.
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	Low risk	Investigators evaluated blood loss "in the standard way" by measurement of blood and clots in a graduated jug, and by weighing swabs and linen.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"12 patients had to be excluded from the trial (oxytocin 5; syntometrine [ergometrine plus oxytocin] 7) after randomisation because they no longer fulfilled the inclusion criteria... [including] 2 who required caesarean section (1 in each group) and 10 who were delivered by forceps or ventouse (oxytocin 4; syntometrine [ergometrine plus oxytocin] 6)."
Selective reporting (reporting bias)	Unclear risk	The protocol of the study was unavailable for verification.
Intention to treat analysis	High risk	Those who withdrew from the study after randomisation were not included in the analysis.
Funding source	Unclear risk	Source(s) of funding for the study were not reported.