Assessment of Perinatal Outcome by use of Specific Tocolytics in Early Labour.
Subtitle: Nifedipine versus Atosiban in the treatment of threatened preterm labour.
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Preterm labour is one of the most important obstetric problems throughout the Western world and occurs in approximately 10% of all deliveries. Preterm birth is the leading cause of perinatal mortality(70 %) and accounts for 40 % of severe neurological morbidity. Tocolysis for a period of two days is crucial in the treatment of threatened preterm labour, in order to allow for corticosteroids to exert their optimal effect on fetal lung development. The optimal tocolytic drug however, is subject to controversy. We hypothesize that Nifedipine as compared to Atosiban will result in an improved neonatal outcome.
Multicenter randomized controlled trial.
500 pregnant women with threatened preterm labour between 25 and 34 weeks gestational age.
Nifedipine (dosage: 4 dd 20 mg orally for 48 hours) versus Atosiban (dosage: bolus injection of 6,75 mg i.v. in 1 minute, followed by 18 mg/hour for 3 hours followed by a maintenance dosage of 6 mg/hour for 45 hours) for 48 hours.
The primary outcome of the study will be a composite for poor neonatal outcome. This outcome will include bronchopulmonary dysplasia (BPD), periventricular leucomalacia > grade 1, intracerebral haemorrhage > grade2, necrotising enterocolitis > stage 1, proven sepsis and in-hospital death. Secondary outcomes will be time to delivery, gestational age at delivery, number of days on ventilation support, in NICU and total days of the baby alive outside the hospital counted from a gestational age of 37 weeks and maternal side effects.
The analysis will be by intention to treat. Adverse neonatal outcome will be tested for a differenceof 10%.
Total 36 months.
Dr. M.A. Oudijk, Gynaecologist, UMCU.
Health Technology Assessment
Prof. dr. B.W. Mol, gynaecologist and clinical epidemiologist, AMC Amsterdam
Dr. B.C. Opmeer, clinical epidemiologist,AMC Amsterdam
Drs. K. Heida, UMCU