Methods |
4‐arm active‐controlled double‐dummy randomised trial |
Participants |
1800 women were randomised in a hospital setting in Turkey. The population comprised women of any parity, either singleton or multiple pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing caesarean section, or those with gestational age less than 32 weeks or hypersensitivity to prostaglandins. |
Interventions |
400 mcg plus 10 IU of misoprostol plus oxytocin administered orally plus by an IV infusion versus 400 mcg of misoprostol administered orally versus 10 IU of oxytocin administered by an IV versus 200 mcg plus 10 IU of ergometrine plus oxytocin administered IM plus by an IV infusion |
Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; vomiting; 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 without any blocking or stratification. |
Allocation concealment (selection bias) |
Low risk |
Used sealed, consecutively‐numbered opaque envelopes. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The placebo tablets were similar in size and colour but were not identical in shape to the misoprostol tablets. To minimise this limitation, the preparation and administration of the medication were carried out by a midwife who had not been involved in the management of the patient except for drug administration." |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The placebo tablets were similar in size and colour but were not identical in shape to the misoprostol tablets. To minimise this limitation, the preparation and administration of the medication were carried out by a midwife who had not been involved in the management of the patient except for drug administration." |
Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by collection with a sterile steel bedpan and plastic bed linen from immediately after delivery. Gauzes and pads were also collected 1 hour after delivery of the placenta and weighed. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "The data for 226 patients were excluded because of caesarean deliveries performed after randomisation (n = 206) and the lack of predelivery (n = 6) or postpartum (n = 14, short hospital stay) haemoglobin concentrations." |
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. |