Nonnenmacher 2009.
Methods | Prospective, randomised, controlled trial. | |
Participants | 105 women > 18 years at 24‐33 completed weeks' gestation, ≥ 4 contractions every 30 min lasting ≥ 30 seconds, opening of the uterine orifice and/or an ultrasound‐verified residual cervix < 25 mm for single pregnancies and < 20 mm for multiple pregnancies. Exclusion criteria: heavy vaginal bleeding, severe pre‐eclampsia, extreme high blood pressure, temperature > 37.5ºC, fetal or placental abnormalities (e.g. chorioamnionitis, premature separation of the placenta, delayed intrauterine growth, fetus in a stressed state, intrauterine fetal death, severe dysplasia, severe maternal health problems, e.g. heart or circulatory disease, hyperthyroidism, alcohol or drug abuse and hypersensitivity to any component of the study drug. |
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Interventions | ORA group: atosiban. Bolus injection of 6.75 mg, then 18 mg/h for 3 h (i.v.) and thereafter 6 mg/h up to 45 h. Control group: fenoterol. 2 x 0.5 mg ampoules in 50 mL NaCl solution by pulsatile administration with an allowance of 1000 IU heparin. Initial dose 1.5 µg/min or 2.0 µg/min; if no improvement was seen after 30 min, the dose was incrementally increased to 3.5 µg/min. At cessation of labour the dose was reduced within 3‐6 h to 1 µg/min and 0.5 µg/min. |
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Outcomes | Percentage of women who experienced a prolongation of pregnancy. Primary endpoints: proportion of women who experienced a prolongation of pregnancy of 48 h and 7 days. Secondary endpoints: time to reduction of contractions to ≤ 1/30min, maternal and fetal side effects and neonatal outcomes. |
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Notes | Publication has been translated to English by the Cochrane Pregnancy and Childbirth Group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unable to determine how randomisation was performed. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unlikely. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomised were included in analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported as expected. |
Other bias | Low risk | None apparent. |