Chopra 2015.
Methods | Randomised controlled trial. | |
Participants | Inclusion: induction of labour, singleton fetus in cephalic presentation, 36–42 weeks of gestation. Exclusion: associated medical‐surgical disorders, previous uterine scar, parity > 3, fetal major congenital malformations or intrauterine demise, persistent non‐reassuring fetal heart rate pattern. Setting: Post Graduate Institute of Medical Education and Research, Chandigarh, India 2009‐2010 (period of inclusion). Number of included participants: 51 in discontinued group versus 53 in continued group. |
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Interventions |
Oxytocin infusion was initiated at a rate of 3 mlU/minute and was increased every 30 minutes by 3 mlU/minute until regular contractions at a rate of 3–5 contractions/10 minutes were achieved. The maximum dose of oxytocin was 42 mu/minute. Infusion of oxytocin was incremental until 4 cm to 6 cm cervical dilation, which, along with 3–5 contractions in 10 minutes, marked the active stage of labour. At cervical dilatation of 4 cm to 6 cm, amniotomy was performed in those with intact membranes and the patients were randomised. |
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Outcomes |
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Notes | No funding was provided for the trial. Trial authors declare no conflict of interest. The trial was not registered. Discontinued group 3.8% non‐compliance (had oxytocin restarted due to lack of progression). Additional data on outcomes not reported in the paper were provided by the author. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation programme. |
Allocation concealment (selection bias) | Unclear risk | Sealed opaque envelopes were used. Envelopes were not numbered. No flow diagram or record of missing envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Possible blinding of participants. Participants in discontinued group receive isotonic saline when active phase is established. No blinding of personnel is described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding is described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | No flow diagram to illustrate allocation. No information on the number of eligible women. 2% post‐randomisation exclusion. 106 included participants. Data are reported for 104 participants (51 in discontinued group versus 53 in continued group). Missing values are not reported. Additional data on postpartum haemorrhage, need for resuscitation, incidence of neonatal respiratory distress, neonatal hypoglycaemia, Apgar scores and neonatal hyperbilirubinaemia provided by author since only reported as quote: "not significantly different between the two groups" in the publication. |
Selective reporting (reporting bias) | High risk | No published protocol prior to article. |
Other bias | Unclear risk | No other source of bias noted. |