Tocolysis Atosiban Nifedipine Preterm Labour Tocolyse Vroeggeboorte
Conditions
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.
Sponsors
AMC Amsterdam
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Vaginal bleeding; 2. Cerclage; 3. Cervical dilatation > 30 mm; 4. Previous treatment for preterm contractions; 5. Hypertension / anti-hypertensiva; 6. Myocard infarction (<1 month); 7. Unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactK. Heida
Dept. of Obstetrics UMC Utrecht
Outcome results
None listed