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APOSTEL IV Study

 

 

Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour - Nifedipine versus placebo in the treatment of preterm premature rupture of membranes

 

Note: the Apostel IV study has been stopped. Please refer to the website for additional details.


Go to the APOSTEL IV website.


Objective
In the Netherlands, preterm birth is responsible for over 75% of all neonatal deaths and 50% of childhood neurological morbidities. 25 to 40% of the cases of preterm birth start with premature preterm rupture of membranes (PPROM). This makes PPROM, in combination with preterm labor (contractions before 37 weeks' gestation) the leading identifiable cause for preterm delivery. PPROM itself complicates in approximately 3 to 5% of all pregnancies. At present, in women with PPROM tocolysis is sometimes applied, but there is no uniform guideline. It is not clear if tocolytic treatment is effective in patients with PPROM and, if so, whether the effects justify the additional costs of this treatment.

 

Study design
Randomized double-blind placebo-controlled trial performed in all ten perinatal centers in The Netherlands.


Study population
Women with PPROM between 24+0/7 and 33+6/7 weeks gestational age.

 

Intervention [or: Methods]
Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour ( >= 3 contractions per 10 minutes).

 

Outcome measures
Primary study parameters/outcome of the study:

The main outcome measure will be a composite poor neonatal outcome, including chronic lung disease, PVL grade > 1, IVH grade > 2, NEC, proven sepsis and perinatal death.

 

Secundary study parameters/outcome of the study:

Secondary outcomes will be gestational age at delivery, birth weight, number of days on ventilation support, in NICU and total days in hospital. In case of a not optimal maternal or neonatal condition at 6 weeks post partum, the mother and/or her child will be followed until 12 months.

 

Power/data analysis
The initial analysis will be according to the intention to treat principle. A difference in reduction of compound morbidity from 30% to 10%, with a beta of 0,2 at alpha of 0.05 can be detected if 120 patients can be analysed (60 in each arm).


Time schedule
Start in 2012

Projectleaders
Prof. dr. B.W. Mol, gynaecologist and clinical epidemiologist, AMC Amsterdam

Health Technology Assessment and methodology
Prof. dr. B.W. Mol, gynaecologist and clinical epidemiologist,
AMC Amsterdam
Dr
.  B.C. Opmeer, clinical epidemiologist,AMC Amsterdam


Contact

Drs. T.A.J. Nijman

Dept. Obstetrics/Gynaecology

UMCU (Utrecht)

Tel: +31 (0)887554913

apostel4@studies-obsgyn.nl