Ozturk 2015.
Methods | Randomised controlled trial. | |
Participants | Inclusion: nulliparity, gestational age between 36 and 42 weeks, singleton fetus, vertex presentation, expected fetal weight < 4000 g, no contraindication for labour induction or augmentation. Exclusion: Setting: Ministry of Health Ankara Etlik Zu¨beyde Hanım Maternity and Women’s Health Training and Research Hospital, Ankara, Turkey, April 2005 to September 2005 (period of inclusion). Number of included participants: 130 (64 continued group versus 66 in discontinued group). |
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Interventions |
In the continued group, incremental oxytocin infusion was administered until 5 cm cervical dilatation and then was maintained at the same level until delivery. In the discontinued group, the infusion was discontinued at the onset of the active phase of labour (defined as cervical dilatation of 5 cm). The starting dose of oxytocin was 1 to 2 mIU/minute and the dose was increased by 2 mIU/minute every 15 minutes. The maximum dose for oxytocin was 40 mIU/minute until regular contractions at a rate of 3–5 every 10 minutes were achieved. The oxytocin solution was prepared with 0.9% NaCl at a 1% concentration. |
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Outcomes | Duration of active phase
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Notes | The trial was unregistered. Sources of trial funding: no information provided. Trial authors declare no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information provided: participants were randomly chosen. |
Allocation concealment (selection bias) | High risk | A number was attributed to each patient and the numbers were randomly selected from a closed box to constitute the study and control groups. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7% post‐randomisation exclusions (70 were assigned to each group, analyses were conducted on 66 and 64 in each group). |
Selective reporting (reporting bias) | High risk | No protocol submitted prior to trial initiation and the trial was unregistered. |
Other bias | Unclear risk | No other source of bias noted. The timing of randomisation was not described. No Consort flow diagram was reported. |