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…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study will be a composite for poor neonatal outcome.
This outcome will include chronic lung disease, periventricular leucomalacia >
grade 1, intraventricular haemorrhage > grade 2, 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, number of days in NICU, total days of
the baby alive outside the hospital counted from a gestational age of 37 weeks
and maternal side effects.
Background summary
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 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 is subject
to controversy.
Study objective
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).
Study design
Multicenter randomized controlled trial
Intervention
Nifedipine (dosage: first hour 20 mg followed by 4 dd 20 mg retard orally for
47 hours) versus Atosiban (dosage: 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) for 48 hours.
Study burden and risks
As we compare two strategies that are already applied in current practice, no
additional risks or burden are expected from the study.
Meibergdreef 9
Amsterdam 1105 ZA
NL
Meibergdreef 9
Amsterdam 1105 ZA
NL
Listed location countries
Age
Inclusion criteria
Women * 18 years old with a singleton pregnancy with a gestational age of 24-34 weeks in threatened preterm labour, as defined by:
* Uterine contractions, at least 3 contractions per 30 minutes and a cervical length of * 10 mm ór
* Uterine contractions, at least 3 contractions per 30 minutes and a cervical length of 11-30 mm ánd a positive Fibronectin test ór
* Ruptured amniotic membranes
Exclusion criteria
- Vaginal bleeding
- Cerclage
- Cervical dilatation > 30 mm
- Previous treatment for preterm contractions
- Hypertension / anti-hypertensive agent
- Myocardial infarction (<1 month)
- Unstable angina pectoris
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015782-30-NL |
| CCMO | NL29324.018.09 |