Begum 2013.
Methods | Randomised controlled trial. | |
Participants | Inclusion: women with a singleton fetus in vertex presentation at ≥ 37 weeks to 40 weeks of gestation and induction due to prolonged pregnancy (40‐42 weeks), premature rupture of membranes, or mild pre‐eclampsia/hypertension ≥ 39 weeks. Exclusion: non‐vertex presentation, previous caesarean, multiple pregnancy/hydramnios, cervical dilatation of > 3 cm on admission, congenital fetal anomaly, fetal distress on admission, estimated fetal weight > 4 kg, severe maternal disease/complication (i.e. pre‐eclampsia/eclampsia, APH, diabetes, or heart disease). Setting: Chittagong Medical College & Hospital, Bangladesh, June to December 2004 (period of inclusion). Number of included participants: 50 with continued versus 50 with discontinued oxytocin. No Consort trial flow diagram was provided. Primigravid and multiparous participants were both included and induced with different dose oxytocin regimens. But the rate of each parity was not reported. Participants were recruited prior to induction of labour and quote: "when the cervix was not ripened per vaginal prostaglandin was given first". The rate of prostaglandin use by group was not reported. |
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Interventions |
5 IU and 2.5 IU in 500 mL ringer lactate solution or 5% dextrose in normal saline in primigravid and multigravid patients. Starting dose 10 drops/minute. Drip was increased every half hour until there was effective contractions and 5 cm cervical dilatation was reached. Maximum dose: 20 mu/minute. |
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Outcomes |
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Notes | Sources of trial funding: no information provided. The trial was not registered. 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) | Low risk | Computer‐generated number sequence. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes were opened before dividing the patients in 2 groups. Envelopes were not reported to be numbered and there was no statement about missing envelopes Lack of CONSORT flow diagram. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding and no placebo used. Prostaglandin was administered after envelope opening but the rate by group was not reported. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on the number of eligible women. No flow diagram presented. |
Selective reporting (reporting bias) | High risk | No protocol was published prior to article. Unregistered trial. |
Other bias | High risk | Randomisation was performed when oxytocin infusion was initiated and not when continued or discontinued. |