| Methods |
3‐arm active‐controlled randomised trial |
| Participants |
360 women were randomised in a hospital setting in Egypt. The population comprised women of parity 5 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with medical disorders as cardiac, hepatic, renal, neurologic disorders, thromboembolic disease, blood disorders, diabetes, gestational hypertension and pre‐eclampsia, grand multiparous (> 5), multiple pregnancy, polyhydramnios, macrosomia, APH, prolonged and obstructed labour, scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to tranexamic acid. |
| Interventions |
10 IU of oxytocin administered by an IV bolus versus 600 mcg of misoprostol administered sublingually |
| Outcomes |
The study recorded the following outcomes: PPH at 500; additional uterotonics; transfusion; diarrhoea; nausea; vomiting. |
| 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 |
A statistician prepared computer‐generated randomisation tables. |
| Allocation concealment (selection bias) |
Low risk |
Investigators placed the allocation data in serially numbered closed opaque envelopes. Each envelope had a card noting the intervention type inside. The envelopes were opened only by the principal investigator administering the study medications according to the order of attendance of women. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was unclear. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Immediately after delivery of the baby, and after liquor drainage, the patient was placed over a blood drape of known weight and a graduated container was placed under the delivery bed to collect blood. The amount of blood collected in the blood drape was measured. Then the patient was given pre‐weighed pads, which were weighed 4 hours postpartum. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
Unclear risk |
The authors did not specify whether 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. |
