| Methods |
3‐arm placebo‐controlled randomised trial |
| Participants |
371 women were randomised in a hospital and 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 undergoing induction or augmentation of labour or instrumental delivery, requiring tocolysis or those who refuse to take part or with cardiac disease, multiple pregnancy, non‐cephalic presentation, polyhydramnios, coagulopathy, stillbirth, antepartum haemorrhage, Hb less than 4.8 mmol/L or previous complication in third stage. |
| Interventions |
Placebo versus 5 IU of oxytocin administered IM |
| Outcomes |
The study recorded the following outcomes: PPH at 500; PPH at 1000; additional uterotonics; transfusion; manual removal of placenta; death;blood loss (mL). |
| Notes |
Contact with study authors for additional information: no. Additional data from authors: no |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation list. |
| Allocation concealment (selection bias) |
Low risk |
Used identical study boxes. Care was taken that no difference could be seen or heard between the packages of the ergometrine/placebo tablets and the oxytocin ampoules. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
The study made use of placebo tablets to minimise detection bias between the placebo and the oral ergometrine arm but also included an unblinded oxytocin arm and the comparison of oxytocin versus placebo was unblinded. |
| 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 a "fresh" perineal pad placed under the mother from immediately after birth until 1 hour after the delivery of the placenta. The difference in the weight of the pad before and after delivery was calculated on the basis that 1 g is equivalent to 1 mL of blood. "During delivery some blood was usually spattered on the drapes and gowns of the attendants, although attempts were made to minimise such losses. This gave a constant error of approximately 10%. In addition, the placental interstices contain maternal blood (about 9% of placental weight). As systematic overestimations (amniotic fluid) and underestimations (blood loss) are likely to be equally distributed among the groups, no corrections have been made for them". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "4 women with exclusion criteria were entered erroneously (3 forceps, 1 augmentation). They are considered as non‐participants". |
| 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. |
