17-Alpha hydroxyprogesterone in Multiple pregnancies to Prevent Handicapped InfAnts
Completed
- Conditions
- Multiple pregnancyPregnancy and Childbirth
- Registration Number
- ISRCTN40512715
- Lead Sponsor
- The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 700
Inclusion Criteria
1. Women with a multiple pregnancy
2. Gestational age between 15 and 19 weeks
3. Aged 18 and older
Exclusion Criteria
1. Major congenital anomaly of (one of) the fetuses
2. Death of (one of) the fetuses
3. Early signs of Twin-to-Twin Transfusion Syndrome
4. Primary cerclage
5. Previous preterm birth less than 34 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be composite neonatal morbidity, containing severe Respiratory Distress Syndrome (RDS), BronchoPulmonal Dysplasia (BPD), intraventricular haemorrhage stage IIB or worse, Necrotising EnteroColitis (NEC), proven sepsis and death before discharge.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are:<br>1. Time to delivery<br>2. Preterm birth rate before 32 and 37 weeks<br>3. Days of admission in neonatal intensive care unit<br>4. Maternal morbidity<br>5. Maternal admission days for preterm labour<br>6. Costs