| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
120 women were randomised in a hospital setting in Egypt. The population comprised women of unspecified parity, a singleton pregnancy, at high risk for PPH, who delivered by elective caesarean section. Exclusion criteria comprised women with anaemia (Hb < 8 g/dL), multiple pregnancy, placental abnormality (e.g. placenta praevia, placenta abruption), polyhydramnios, 2 or more previous caesarean deliveries, current or previous history of heart disease, liver, renal disorders or known coagulopathy. |
| Interventions |
400 mcg of misoprostol administered sublingually versus 20 IU of oxytocin administered by an IV infusion |
| Outcomes |
The study recorded the following outcomes: additional uterotonics; blood loss (mL); vomiting; headache; 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 |
Randomisation was done using a computer‐generated random table. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labelled with a serial number and had a card noting the intervention type inside. Allocation was never changed after opening the envelopes." |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Quote: "The volume of blood loss during caesarean delivery and 2 hours postoperatively was assessed. Total blood loss during caesarean delivery was measured by adding the volume of the suction bottle with the blood soaked sponges (know dry weight). Blood loss 2 hours after caesarean delivery was measured by using blood collection drape. The whole blood loss was estimated by adding the blood in the suction bottle, blood soaked sponges and blood collection drape." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
120 women were randomised in the study, but 10 were excluded from the analysis from the oxytocin group after randomisation. |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered prospectively (NCT02562300). |
| Intention to treat analysis |
High risk |
Those who were excluded 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. |
