| Methods |
2‐arm active‐controlled double‐blinded randomised trial |
| Participants |
216 women were randomised in a hospital setting in Iran. The population comprised women of parity 4 or less, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with hypertension, pre‐eclampsia, uterine rupture, cervical tear, asthma, cardiovascular/renal/liver disorders, grand multiparity (not defined), fibroids or previous PPH. |
| Interventions |
100 mcg of carbetocin administered IM versus 200 mcg plus 5 IU of ergometrine plus oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: severe maternal morbidity: intensive care admissions; additional uterotonics; death; change in Hb; nausea; vomiting; tachycardia; hypotension; shivering abdominal pain. |
| 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 |
Randomisation was performed using a random number table. |
| Allocation concealment (selection bias) |
Unclear risk |
Allocation concealment was not reported. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote "Patients and medical personnel were blinded to the type of drug". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors were blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Blood loss was not measured. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
At 24 hours postpartum, blood samples could not be collected from 16 women (9 in the carbetocin group and 7 in the ergometrine plus oxytocin group). |
| Selective reporting (reporting bias) |
Low risk |
The study report matches the study protocol that was registered (Iranian registry of clinical trials number 138810212854N2). |
| Intention to treat analysis |
High risk |
The authors excluded 16 study participants from the analysis because postpartum haemoglobin measurements were not available. |
| Funding source |
Unclear risk |
The study was supported by funding from the Kashan University of Medical Sciences (the institution of the authors). |
