Turkey 2010.
Methods | Randomised controlled study. | |
Participants | 200 term singleton pregnancies undergoing spontaneous vaginal and elective caesarean section at the University Hospital in Eskisehir, Turkey. Exclusion criteria included known sensitivity to prostaglandins, excessive postpartum haemorrhage with haemodynamic instability that necessitated blood transfusion. Assisted vaginal delivery, use of epidural anaesthesia and cases with labour induction. |
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Interventions | Controlled release PGE2 vaginal insert (Dinoprostone) with a constant delivery of 0.3 mg/hr for 12 hours versus IV oxytocin infusion in balanced solution (10 IU for vaginal, 20 IU for caesarean delivery). | |
Outcomes | Main outcome measures: amount of bleeding, need for additional oxytocins, haemoglobin and haematocrit level changes during the postpartum period and drug related side‐effects such as nausea, vomiting, shivering, pyrexia and diarrhoea and postpartum vaginal or endometrial infections. Some of these results have been reported by subgroup only (caesarean section, vaginal delivery). |
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Notes | Active management of third stage of labour for the vaginal births. In cases undergoing caesarean section, 20 IU intravenous oxytocin infusion was given after the delivery of the placenta. Estimated amount of postpartum blood was assessed via a gravimetric method by counting the blood‐filled pads within 24 hours of postpartum. Dry weight of the pads was assessed prior to delivery. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear how the random sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Not clear how the allocation concealment was done. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not clear on blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up or postrandomisation exclusions were reported. |
Selective reporting (reporting bias) | Unclear risk | Not all of the primary outcomes of the review were reported and some of them have only been reported within the subgroups (vaginal/caesarean section). |
Other bias | Low risk | Demographic characteristics did not differ between the 2 groups. |