|- candidate number||9804|
|- NTR Number||NTR2947|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jun-2011|
|- Secondary IDs||09/258 METC AMC|
|- Public Title||Nifedipine versus Atosiban in the treatment of threatened preterm labour: APOSTEL III.|
|- Scientific Title||Assessment of Perinatal Outcome by use of SpecificTocolytics in Early Labour.|
|- ACRONYM||APOSTEL III|
|- hypothesis||The aim of the study is to compare the effectiveness of tocolysis with Nifedipine or Atosiban in pregnant women with threatened preterm labour with a gestational age between 25 – 34 weeks. We will look at neonatal mortality and morbidity, duration of pregnancy and to maternal side effects.|
|- Healt Condition(s) or Problem(s) studied||Nifedipine, Tocolysis, Preterm birth, Atosiban|
|- Inclusion criteria||Women ≥ 18 years old with a singleton pregnancy with a gestational age of 25-34 weeks in threatened preterm labour, as defined by:|
Uterine contractions, at least 3 contractions per 30 minutes, and one of the following:
1. Cervical length of ≤ 10 mm ór;
2. Cervical length of 11-30 mm ánd a positive Fibronectin test ór;
3. Ruptured amniotic membranes.
|- Exclusion criteria||1. Vaginal bleeding;|
3. Cervical dilatation > 30 mm;
4. Previous treatment for preterm contractions;
5. Hypertension / anti-hypertensiva;
6. Myocard infarction (<1 month);
7. Unstable angina pectoris.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-jun-2011|
|- planned closingdate||1-jul-2014|
|- Target number of participants||500|
|- Interventions||1. In the Nifedipine group, the initial dose will be 20 mg orally in the first hour, followed by 20 mg per 6 hours for the next 47 hours;|
2. In the Atosiban group, a Bolus injection of 6,75 mg i.v. in 1 minute, followed by a 18 mg/hour for 3 hours followed by a maintenance dosage of 6 mg/hour for 45 hours.
|- Primary outcome||The primary outcome measure will be a composite poor neonatal outcome, including broncho pulmonary dysplasia (BPD), periventricular leucomalacia (PVL) > grade 1, intracerebral haemorrhage > grade 2, necrotising enterocolitis (NEC) > stage 1, proven sepsis and in-hospital death. |
|- Secondary outcome||Secondary outcomes will be time to delivery, gestational age at delivery, number of days on ventilation support, in NICU, total days of the baby alive outside the hospital counted from a gestational age of 37 weeks and maternal side effects.|
|- Timepoints||The outcomes will be registered at time of discharge home or at 36 weeks of corrected GA in case of BPD. |
|- Trial web site||http://www.studies-obsgyn.nl/apostel3|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. K. Heida|
|- CONTACT for SCIENTIFIC QUERIES||Drs. K. Heida|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam, Consortium for women's health and reproductivity studies, Obstetric research consortium|
|- Brief summary||Rationale: |
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.
To compare the effectiveness of the tocolytic agents Nifedipine (a calcium channel blocking agent) versus Atosiban (an oxytocin receptor antagonist) in the improvement of neonatal outcome in women with threatened preterm labour (25-34 weeks gestation).
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.
Main study parameters/endpoints:
The primary outcome measure will be a composite poor neonatal outcome, including broncho pulmonary dysplasia (BPD), periventricular leucomalacia (PVL) > grade 1, intracerebral haemorrhage > grade 2, necrotising enterocolitis (NEC) > 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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As we compare two strategies that are already applied in current practice, no additional risks or burden are expected from the study.
|- Main changes (audit trail)|
|- RECORD||20-jun-2011 - 14-jul-2014|