| Methods |
2‐arm active‐controlled double‐dummy randomised trial |
| Participants |
400 women were randomised in a hospital setting in Iran. 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 women with placenta praevia, placental abruption, coagulopathy, previous caesarean, macrosomia (more than 4 kg), polyhydramnios or uncontrolled asthma. |
| Interventions |
20 IU of oxytocin administered by an IV infusion versus 400 mcg of misoprostol administered orally |
| Outcomes |
The study recorded the following outcomes: additional uterotonics; transfusion; blood loss (mL); change in Hb; hypotension; fever; shivering. |
| Notes |
Contact with study authors for additional information: yes. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Allocation using simple randomisation with computer‐generated numbers in 1:1 ratio. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
The study was quote: "double‐blind": "for blinding the study, identical‐appearing solutions and tablets corresponding to the 2 pharmacological groups were prepared by the pharmacy and kept in the fridge until required". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss during the first hour after delivery, by collection with pads weighed before and after absorbance of blood. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
The study authors did not mention any incomplete outcome data. |
| Selective reporting (reporting bias) |
High risk |
The study protocol was registered (ClinicalTrials.gov NCT01863706) but not all of the outcomes projected by methodological descriptions were reported as results in the study report (cases of diarrhoea, nausea and vomiting were not completely reported). Moreover, the study publication reports outcomes (hypotension, nausea, transfusion) not listed in the registered protocol. |
| 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 |
Low risk |
The study was supported by funding from the Hormozgan University of Medical Sciences (the institution of the authors). |
