Rashwan 2011.
Methods | Randomised controlled trial. | |
Participants | Inclusion: induction of labour, maternal age 20‐30 years, gestational age 36‐42 weeks, vertex presentation, Bishop score > 4, no indication for caesarean section (inadequate pelvis, cephalopelvic disproportion, persistent non‐reassuring fetal heart rate, scarred uterus), no chronic or pregnancy‐induced illness. Setting: Kasr Al‐Aini Maternity Hospital, Cairo, Egypt, 1 st of September 2008 to the 15th of June 2010 (period of inclusion). Number of included participants: 200 women (continued group 100 women (60 nulliparous and 40 multiparous) versus discontinued group 100 women (60 nulliparous and 40 multiparous)). |
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Interventions |
In group I, oxytocin was continued throughout labour. In group II, oxytocin was discontinued when the active phase of labour was established (not defined by the authors). Induction of labour was started in all patients using the low‐dose protocol suggested by ACOG by oxytocin intravenous drip infusion at a rate of 1 mIU/minute (5 IU of oxytocin was diluted in 500 mL of 0.9% NaCl). The dose was increased every 20 minutes by 1 mIU/minute until regular contractions at a rate of 3 to 5 per 10 minutes were reached. The maximal allowed dose of oxytocin was 20 mIU/minute. |
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Outcomes | Primary outcome
Secondary outcome
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Notes | Trial was unregistered. Sources of trial funding: no information provided. Information on declaration of interest is absent from the trial report. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding of outcome assessor is not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No data on number of eligible women. No Consort flow diagram. Timing of randomisation in relation to labour not stated. No statement about post‐randomisation exclusions. |
Selective reporting (reporting bias) | High risk | No protocol published prior to trial initiation. Trial was unregistered. |
Other bias | Unclear risk | No other sources of bias noted |