Harriott 2009

Methods	2‐arm active‐controlled randomised trial.
Participants	Over 6 months between dates unspecified, 140 parturients were randomised in a hospital setting in West Indies. 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 comprised parturients with previous PPH, hypertension, previous caesarean, intrauterine death, sepsis/pyrexia (more than 38°C), antepartum haemorrhage or Hb less than 80 g/L.
Interventions	500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 70) versus 400 mcg of misoprostol administered rectally (n = 70).
Outcomes	The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, death, blood loss (mL), change in Hb level, third‐stage duration (min), nausea, vomiting, hypertension, 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	Computer‐generated block randomisation was used to randomly assign participants.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Both the patient and the midwife conducting the delivery were aware of the drug administered."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessors were not blinded to treatment allocations.
Objective assessment of blood loss	Low risk	Investigators evaluated blood loss by collection with a modified plastic drape placed under the mother from the commencement of the third stage of labour, until 1 hour after delivery. The collection drape measured 168 cm by 84 cm, and contained folded over side‐wings (to act as a chute) and a 34‐cm collection pouch made by folding the distal end of the drape. Standard sterile drapes were placed above the blood collection drape. Every effort was made to avoid soiling the sterile drapes before delivery of the baby, because they were not weighed. After delivery, overlying sterile drapes were removed to facilitate the use of the collection drape.
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 Mona Campus and Research Publication Committee of the University of the West Indies (the institution of the authors).