| Methods |
2‐arm controlled randomised trial |
| Participants |
1802 women were randomised in a hospital setting in Sweden. 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 undergoing elective caesarean section, or those who were non‐Swedish speaking or with previous PPH, pre‐eclampsia, grand multiparity (more than 4) or intrauterine death. |
| Interventions |
10 IU of oxytocin administered by an IV bolus versus no treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 1000; transfusion; manual removal of placenta; blood loss (mL); change in Hb; third stage duration (minutes); maternal satisfaction. |
| 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 |
Computer‐generated sequence. |
| Allocation concealment (selection bias) |
Low risk |
Used sealed envelopes containing the randomisation group prepared in consecutive order and kept in another unit. At randomisation, midwives phoned the staff at the other unit who opened the envelopes and disclosed the assigned intervention and trial number. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "Because of the nature of the study, blinding was not possible for the midwives, but the women were not informed of which management was to be used for them". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Assessors were not blinded to treatment allocations. |
| Objective assessment of blood loss |
Low risk |
Investigators appraised blood loss by removing pads soaked with amniotic fluid and placing a dry sanitary pad under the mother, immediately after the birth of the baby. They weighed all sanitary towels and pads before and after use. Blood loss was recorded (a) between the birth of the baby and the expulsion of the placenta, and (b) from expulsion of the placenta up to 2 hours postpartum. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
171 randomised women were not included in the study analysis. Among those randomised to receive oxytocin, 4 withdrew consent, 75 had caesareans, and 14 were lost to follow up. In the control group, 2 withdrew consent, 56 had caesareans, and 20 were lost to follow up. |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol of the study was unavailable for verification. |
| Intention to treat analysis |
High risk |
The authors excluded 131 randomised study participants from the analysis because they experienced caesarean deliveries. |
| Funding source |
Low risk |
The study was supported by funding from the Research and Development Board in Göteborg and Bohuslän, Baby Bag and the SU Foundation in Sweden (public funding). |
