Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV); Nifedipine versus placebo in the treatment of preterm premature rupture of membranes
Phase 3
Completed
- Conditions
- premature preterm rupture of membranes10010273
- Registration Number
- NL-OMON35899
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome measure will be a composite neonatal morbidity status,<br /><br>including perinatal death, chronic lung disease, severe intraventricular<br /><br>haemorrhage grade 3 and 4, periventricular leucomalacia more than grade 1,<br /><br>proven sepsis and necrotising enterocolitis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome will be birth weight, gestational age at delivery, number of<br /><br>days on additional oxygen, days on supported ventilation, number of days in<br /><br>intensive care and total days in hospital until 3 months corrected age.</p><br>