| Methods |
Random allocation was by allocating identical numbered boxes containing trial medications. Method of generation of numbers was not stated. Outcome assessments were not blinded. Saline injections were used as placebo. |
| Participants |
74 low‐risk women with spontaneous labour and vaginal delivery in Nijmegen and Bergen op Zoom, Holland. |
| Interventions |
Sulprostone** 0.5 mg IM vs oxytocin 5 IU IM vs saline. |
| Outcomes |
Blood loss, duration of third stage, side‐effects.
Measurement of blood loss: blood and clots collected in trays, swabs and linen weighed for the first hour after delivery. |
| Notes |
Management of third stage: 'conservatively', cord clamped within 1 minute, women asked to push after signs of separation, no cord traction or fundal pressure.
3/77 excluded (2 because of induction of labour, 1 vacuum delivery). There were more multiparous women with fewer episiotomies in the sulprostone group despite randomisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"randomization was within each block of 10." |
| Allocation concealment (selection bias) |
Low risk |
"allocating identical numbered boxes containing trial medications." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinded, placebo controlled. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
3 women were excluded due to induction of labour and vacuum extraction. |
| Selective reporting (reporting bias) |
Low risk |
Primary outcomes of the review have been reported. |
| Other bias |
High risk |
There were more multiparous women with fewer episiotomies in the sulprostone group. To adjust for these factors, the authors used a linear regression model. The trial was stopped after 2 years for organisational reasons. |
