| Methods |
Random allocation to pharmacy coded identical boxes containing trial medications. Outcome assessments were blinded. Placebo use. |
| Participants |
69 women with a history of previous postpartum blood loss of more than 1000 mL were eligible for this trial conducted in Leiden, Holland. Exclusion criteria: coagulation disorders, anticoagulant treatment, fibroids, multiple pregnancy, hypertension and induction of labour were excluded. |
| Interventions |
Sulprostone** 0.5 mg IM at delivery of anterior shoulder + placebo after delivery of placenta vs oxytocin 5 IU IM at delivery of anterior shoulder + methylergometrine 0.2 mg IM after delivery of placenta. |
| Outcomes |
Blood loss, duration of third stage, side‐effects.
Measurement of blood loss: blood and clots were collected in trays and linen weighed. |
| Notes |
Management of third stage: fundal pressure while holding lower segment of the uterus after signs of placental detachment.
12/81 (15%) excluded after randomisation and before the intervention. No further exclusions after participation in the trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"pharmacy coded boxes." |
| Allocation concealment (selection bias) |
Low risk |
Random allocation to pharmacy coded identical boxes containing trial medications. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
12/81 (15%) excluded after randomisation and before the intervention. No further exclusions after participation in the trial. |
| Selective reporting (reporting bias) |
Unclear risk |
Not all of the primary outcomes of the review were reported. |
| Other bias |
Unclear risk |
No mention of the comparability between groups. |
