Premature Preterm Rupture Of Membranes, Nifedipine, Tocolysis
Conditions
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).
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactT.S. Lange, de
Academic Medical Centre Dept Obstetrics and Gynaecology
Outcome results
None listed