Diven 2012.
Methods | Randomised controlled trial. | |
Participants | Inclusion: induction of labour (regardless of indication for induction, Bishop score, parity, or cervical ripening prior to stimulation), singleton gestation > 37 weeks. Exclusion: multiple gestations, previous caesarean delivery, active labour, documented fetal anomalies. Setting: Lehigh Valley Health Network, Allentown, PA, USA, February 2009 to August 2011 (trial inclusion period). Number of included participants: 252 women (125 discontinued group and 127 continued group). |
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Interventions |
Intravenous infusion of oxytocin, 30 IU in 500 mL of 0.9% NaCl, titrated to target 3‐5 contractions in a 10‐minute period. The continued group followed a standard institutional oxytocin protocol in which usual practice is to continue oxytocin until delivery, unless there was an indication to stop the infusion. The discontinued group had oxytocin discontinued once the patient was deemed to be in active labour by the obstetrician. Active labour was defined by the clinician’s assessment of regular uterine contractions with a cervical examination that confirmed dilatation of 4 cm. |
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Outcomes | Primary outcome
Secondary outcomes
Maternal
Neonatal
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Notes | Discontinued group: 24.8% never had oxytocin discontinued when they reached active phase of labour and 46.4% had oxytocin restarted due to lack of progression. 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 | Allocation was random, but method not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
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 | Low risk | Flow diagram illustrates enrolment. No post‐randomisation exclusions. Intention‐to‐treat analysis was performed. |
Selective reporting (reporting bias) | Low risk | Protocol published on clinicaltrials.gov (NCT00957593). Primary outcome registered as mode of delivery and secondary outcome: perinatal outcome (not further defined). All pre‐specified outcomes in the article were reported. |
Other bias | High risk | According to the power calculation, 304 participants were to be included, but recruitment was terminated at 252 participants due to low inclusion rate and high number of protocol violations (> 70% in the intervention group). |