| Methods |
2‐arm active‐controlled randomised trial |
| Participants |
100 women were randomised in a hospital setting in India. 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 grand multiparity (more than 4), anaemia, malpresentation, polyhydramnios, antepartum haemorrhage, liver/renal disorder, previous caesarean, previous PPH, uterine anomaly, traumatic PPH or contraindications to use misoprostol or oxytocin. |
| Interventions |
10 IU of oxytocin administered by an IV infusion versus 600 mcg of misoprostol administered sublingually |
| Outcomes |
The study recorded the following outcomes: PPH at 500. PPH at 1000; severe maternal morbidity: intensive care admissions; additional uterotonics; transfusion; death; blood loss (mL); change in Hb; third stage duration (minutes); diarrhoea; nausea; vomiting; fever; 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 |
Computer‐generated random number sequence. |
| Allocation concealment (selection bias) |
Unclear risk |
Used sequentially‐numbered, opaque envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote "Due to [the] nature of administration of the drugs, [the] patient or clinical care team could not be blinded. However, [the] statistician was unaware of the group allocation". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Investigators removed any linen soiled with amniotic fluid, and placed a calibrated plastic bag under the mother to collect blood from the uterine cavity. After delivery of the placenta, a pre‐weighed pad was placed high up in vagina until 1 hour afterwards. In cases of episiotomy, a separate pad was applied to the episiotomy site, and the fluid collected by this pad was not included in blood loss measurements. |
| 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. |
