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APOSTEL II study

Assessment of Perinatal Outcome after Sustained Tocolysis for Early Labour (APOSTEL)


Go to the Apostel website.

 

Objective

It is evident that tocolysis with administration of corticosteroids is effective for 48 hours. At present, no unanimity exists among obstetricians, regarding benefits of sustained tocolysis. On the one hand, tocolytics maintenance therapy with calcium channel blockers might be beneficial due to its positive effect on gestational age. On the other hand, its use of tocolytics can be associated with side effects for mother and child. Moreover, prolongation of pregnancy might also increase the chance for perinatal complications such as infection.

Study design
Multicentre randomised placebo-controlled trial. The study
will be performed within a consortium of ten perinatal centres, which are collaborating in several proposed studies. Study population: women with a gestational age between 24 and 31+6 weeks who have been treated with tocolysis and steroids for preterm birth for 48 hours are eligible for the trial.

 

Inclusion criteria:
Gestational age between 26 and 32+2 weeks

Diagnosis of threatened preterm birth

Treatment with tocolysis according to local protocol for 48 hours

Completed course of corticosteroids

 

Exclusion criteria:
Signs of intrauterine infection
Signs of fetal distress

Placenta praevia
Maternal disease (ie. severe preeclampsia, HELLP syndrome)

Maternal hypertension

Contra-indication for use of nifedipine

 

Intervention
Treatment with 80 mgs Nifedipine or placebo for 12 days.

 

Outcome measures
Main outcome will be neonatal mortality, neonatal morbidity (severe respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage more than grade 2, periventricular leucomalacia more than grade 1, proven sepsis, necrotising enterocolitis) and birth weight. Secondary outcome will be gestational age at delivery, days on supported ventilation, days on additional oxygen, days in NICU, total days in hospital until 3 months corrected age, costs.

 

Power/data analysis
The analysis will be by intention to treat. A difference in reduction of compound morbidity from 25% to 15%, with beta of 0,2 and alpha of 0,05 can be detected if 400 patients can be analysed (200 in each arm).

Time schedule
36 months. Three months preparation. Thirty months inclusion. Three months analysis and report.

 

Projectleaders
Prof. dr. F.K. Lotgering, gynaecologist, Radboud University Nijmegen

Prof. dr. J.A. van der Post, gynaecologist, AMC Amsterdam

Health Technology Assessment & Methodology
Dr. B.W. Mol, gynaecologist, AMC Amsterdam

Dr.  B.C. Opmeer, clinical epidemiologist, AMC Amsterdam
 
Subsidy
ZonMw -
www.zonmw.nl