premature preterm rupture of membranes
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
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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: Women with *3 contractions per 10 minutes, woman with symptoms justifying start of tocolysis, women with ruptured membranes longer than 72 hour, women having signs of chorioamnionitis or signs of intra uterine infection, women whose child has signs of fetal distress (abnormal CTG, abnormal biophysical profile) or women with any contraindication for the use of nifedipine or having a maternal disease (hypertension, HELLP syndrome, preeclampsia or other) as reason for delivery.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will be birth weight, gestational age at delivery, number of days on additional oxygen, days on supported ventilation, number of days in intensive care and total days in hospital until 3 months corrected age. | — |
Primary
| Measure | Time frame |
|---|---|
| The main outcome measure will be a composite neonatal morbidity status, including perinatal death, chronic lung disease, severe intraventricular haemorrhage grade 3 and 4, periventricular leucomalacia more than grade 1, proven sepsis and necrotising enterocolitis. | — |
Countries
Netherlands
Outcome results
None listed