| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
100 women were randomised in a hospital setting in Nigeria. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by both elective or emergency caesarean. Exclusion criteria comprised women requiring general anaesthesia, or those with multiple pregnancy, placenta praevia, antepartum haemorrhage, cardiac/renal/liver disorders, coagulopathy, asthma, glaucoma, pre‐eclampsia, eclampsia, prolonged labour or contraindications to administration of prostaglandins. |
| Interventions |
20 IU of oxytocin administered by an IV infusion versus 400 mcg of misoprostol administered sublingually |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; blood loss (mL); nausea; vomiting; headache; hypotension; shivering. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Allocation sequence was developed by a statistician who was not otherwise involved with the study using computer‐generated table of random numbers and varied permutated blocks. |
| Allocation concealment (selection bias) |
Low risk |
Used sealed, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "The anaesthetist was blind to the allocation until he opened each participant’s envelope at surgery. The obstetricians were unaware of what oxytocic was given as the faces of the patients were screened off during the surgery". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "The obstetricians were unaware of what oxytocic was given as the faces of the patients were screened off during the surgery". |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by collection in a suction bottle, and by weighing delivery drapes and gauzes on the basis that 1 g is equivalent to 1 mL of blood. Quote: "Both the surgeon and anaesthetist estimated blood loss independently. The scrub nurse weighed the drapes and gauze before and after the operation, noted the amount of blood in the suction bottle, and recorded these. The postoperative care nurse also recorded the blood loss during the first 4 hours after surgery". Finally a research assistant (not part of the medical team) calculated the mean estimated blood loss from all these values. |
| 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 |
Unclear risk |
Source(s) of funding for the study were not reported. |
