Pessaries in mulitple pregnancy as a prevention of preterm birth
Completed
- Conditions
- multiple pregnancypreterm birth10010273
- Registration Number
- NL-OMON33360
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion Criteria
All women presenting with a multiple pregnancy (monochorionic and bichorionic) between 12 and 20 weeks of gestation are eligible for the study
Exclusion Criteria
Women with multiple pregnancies in which at least one of the fetus(es) has major congenital anomalies known at study entry will not be included
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome parameter is the composite morbidity rate of children in the<br /><br>two groups. This composite morbidity rate contains the following variables:<br /><br>severe Respiratory Distress Syndrome (RDS), Broncho Pulmonal Dysplasia (BPD),<br /><br>Intraventricular Haemorrhage II B or worse, Necrotizing Enterocolitis (NEC),<br /><br>proven sepsis and death before discharge from the nursery (6). They will be<br /><br>measured until 6 weeks after the date of delivery. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are time to delivery, preterm birth rate before 32<br /><br>and 37 weeks, days of admission in neonatal intensive care unit, maternal<br /><br>morbidity, maternal admission days for preterm labour and costs. At present, a<br /><br>longer follow-up is not planned.</p><br>