| Methods |
2‐arm controlled randomised trial |
| Participants |
1704 women were randomised in a community setting in the Netherlands. The population comprised women of any parity, a singleton pregnancy, at low risk for PPH, who delivered by vaginal delivery. Exclusion criteria comprised women with indications for a prophylactic approach to the third stage management in primary midwifery care and women with poor command of the Dutch language. |
| Interventions |
5 IU of oxytocin administered IM versus no treatment |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000.;additional uterotonics; transfusion; third stage duration (minutes); breastfeeding; nausea; vomiting; headache; abdominal pain; maternal well‐being. |
| 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 |
Randomisation was carried out by a lottery method Quote: "Randomization was achieved using two numbered and sealed opaque envelopes. Each envelope contained a sticker indicating one of the allotted treatments. When the midwife was confident that the birth would be completed in her care (defined for primigravid women when a large part of the baby’s head was presenting and for multiparous women at the beginning of the second stage of labor), the woman herself or someone else designated by her would choose one of the two envelopes." |
| Allocation concealment (selection bias) |
High risk |
Allocation concealment was not reported but unlikely to have been implemented with a lottery method of randomisation. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded. |
| Objective assessment of blood loss |
Low risk |
Used digital scales, 10 disposable pre‐weighed incontinence pads (a small impermeable multilayered sheet with high absorbency) and graduated measuring cups. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1704 women were randomised in the study, but 18 were excluded because of referral to hospital (n = 16) and were lost to follow‐up or withdrew from the study (n = 2) after randomisation. |
| 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 |
Low risk |
The trial was funded by the Prevention Fund of the Netherlands. |
