Methods |
2‐arm active‐controlled randomised trial. |
Participants |
Between January 2003 and December 2003, 686 parturients were randomised in a hospital setting in Saudi Arabia. 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 requiring oxytocin infusion in the third stage, or those with pre‐eclampsia, cardiac disorder, hypertension on treatment, antepartum haemorrhage, pre‐term labour (less than 37 weeks), post maturity (more than 42 weeks) or Hb less or equal to 90 g/L. |
Interventions |
500 mcg plus 5 IU of ergometrine plus oxytocin administered intramuscularly (n = 340) versus 10 IU of oxytocin administered by an intravenous infusion (n = 346). |
Outcomes |
The study recorded the following outcomes: PPH at 500, PPH at 1000, additional uterotonics, transfusion, manual removal of placenta, blood loss (mL), third‐stage duration (min), nausea, vomiting headache. |
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 numbers. |
Allocation concealment (selection bias) |
Unclear risk |
Investigators used sequentially‐numbered, sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk |
Study participants and caregivers were not blinded to treatment allocations. |
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 "clinically in a standard way" by collection with a plastic sheet that was subsequently drained (with clots) into a graduated measuring jug, and by weighing swabs and towels. "Any delayed haemorrhage within 24 hours after delivery was calculated." |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Outcome data were collected completely from all randomised study participants. |
Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification, but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of requirement for additional syntometrine [ergometrine plus oxytocin] were omitted). |
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. |