Preterm delivery threatened preterm birth
Conditions
Interventions
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 fol
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Vaginal bleeding - Cerclage - Cervical dilatation > 30 mm - Previous treatment for preterm contractions - Hypertension / anti-hypertensive agent - Myocardial infarction (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed