Study information


APOSTEL III study

 

Assessment of Perinatal Outcome by use of SpecificTocolytics in Early Labour.
Subtitle: Nifedipine versus Atosiban in the treatmentof threatened preterm labour.


Objective
Preterm labour is one of the most importantobstetric 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 aperiod of two days is crucial in the treatment of threatened preterm labour, inorder to allow for corticosteroids to exert their optimal effect on fetal lungdevelopment. The optimal tocolytic drug however, is subject to controversy. Wehypothesize that Nifedipine as compared to Atosiban will result in an improvedneonatal outcome.

Study design
Multicenter randomized controlled trial.

Study population
500 pregnant women with threatened preterm labour between 25 and 34 weeks gestational age.

Intervention [or: Methods]
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/hourfor 3 hours followed by a maintenance dosage of 6 mg/hour for 45 hours) for 48hours.

Outcome measures
The primary outcome of the study will be a composite for poor neonataloutcome. 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 aliveoutside the hospital counted from a gestational age of 37 weeks and maternalside effects.

Power/data analysis
The analysis will be by intention to treat. Adverse neonatal outcome will betested for a differenceof 10%.

Time schedule
Total 36 months.

Projectleaders
Drs. K.Y. Heida, PhD student, UMCU

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

Contact
Drs. E.O.G. van Vliet, UMCU.