|- candidate number||12099|
|- NTR Number||NTR3363|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mrt-2012|
|- Secondary IDs||11/092 MEC AMC |
|- Public Title||Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour: Nifedipine versus placebo in the treatment of preterm premature rupture of membranes.|
|- Scientific Title||Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour: Nifedipine versus placebo in the treatment of preterm premature rupture of membranes.|
|- ACRONYM||APOSTEL IV|
|- hypothesis||The aim of the study is to assess whether in women with early PPROM tocolytics improve perinatal outcome.|
|- Healt Condition(s) or Problem(s) studied||Premature Preterm Rupture Of Membranes, Nifedipine, Tocolysis|
|- Inclusion criteria||All women with a gestational age between 24+0/7 and 33+6/7 weeks with ruptured membranes without other signs of active labour are eligible for the trial. |
|- Exclusion criteria||1. Women with ≥3 contractions per 10 minutes;|
2. Woman with symptoms justifying start of tocolysis;
3. Women with ruptured membranes longer than 72 hour;
4. Women having signs of chorioamnionitis or signs of intra uterine infection;
5. Women whose child has signs of fetal distress (abnormal CTG, abnormal biophysical profile);
6. Women with any contraindication for the use of nifedipine;
7. Having a maternal disease (hypertension, HELLP syndrome, preeclampsia or other) as reason for delivery.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||31-dec-2014|
|- Target number of participants||120|
|- Interventions||Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes). |
|- Primary outcome||1. Neonatal mortality;|
2. Composite neonatal morbidity (ie. chronic lung disease, severe intraventricular hemorrhage more than grade 2, periventricular leucomalacia more than grade 1, proven sepsis, necrotising enterocolitis).
|- Secondary outcome||1. Gestational age at delivery;|
2. Birth weight;
3. Number of days in neonatal intensive care;
4. Number of days on supported ventilation;
5. Number of days on additional oxygen;
6. Total days in hospital until 3 months corrected age;
7. Economic analysis.
|- Timepoints||In view of the relatively small sample size, the fact that both treatments are already applied and are both mentioned in the Dutch guidelines, an interim analysis is not planned.|
|- Trial web site||www.studies-obsgyn.nl/apostel4|
|- CONTACT FOR PUBLIC QUERIES|| T.S. Lange, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. B.W.M. Mol|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Consortium for women's health and reproductivity studies, Obstetric research consortium|
|- Publications||Nijman, Tobias AJ, et al. "Nifedipine versus placebo in the treatment of preterm prelabor rupture of membranes: a randomized controlled trial: Assessment of perinatal outcome by use of tocolysis in early labor—APOSTEL IV trial." European Journal of Obstetrics & Gynecology and Reproductive Biology 205 (2016): 79-84.|
|- Brief summary||Rationale: |
At present, women with premature preterm rupture of membranes (PPROM) are in some cases treated with tocolytics and in other cases not. It is unclear whether treatment with tocolytics should take place in order to delay labor.
To assess whether in women with early PPROM tocolytics improve perinatal outcome.
Randomized placebo controlled trial.
Women with PPROM between 24+0/7 and 33+6/7 weeks gestational age.
Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes).
Main study parameters/endpoints:
Primary outcome is composite neonatal morbidity status, i.e. severe morbidity and death at 6 months. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days in hospital.
|- Main changes (audit trail)|
|- RECORD||20-mrt-2012 - 10-nov-2016|