| Methods |
3‐arm controlled randomised trial |
| Participants |
120 women were randomised in a hospital setting in Egypt. The population comprised women of parity 4 or less, a singleton pregnancy, at both high and low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women undergoing induction of labour or instrumental delivery, or those with previous caesarean section, extensive perineal, vaginal or cervical lacerations, bleeding disorders, HB less than 100 g/L, uterine malformations, grand multiparity, multiple pregnancy, polyhydramnios, intrauterine fetal death, medical problems such as pre‐eclampsia, diabetes, cardiopulmonary problems, bowel disease, or allergy to prostaglandins. |
| Interventions |
No treatment versus 200 mcg of misoprostol administered sublingually versus 5 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; blood loss (mL); change in Hb. |
| 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) |
Unclear risk |
Sequence generation was not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Used closed envelopes. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding (of study participants and caregivers) was not reported. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Assessor blinding was not reported. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by collection with sterile packs weighed beforehand and afterwards. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "Following randomisation, 16 study participants were excluded from our analysis. Of these, 14 patients received intrapartum oxytocin, 1 patient experienced extensive vaginal laceration and another experienced a cervical laceration". |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
High risk |
Those who withdrew 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. |
