Quadruple P
- Conditions
- Obstretic labor, prematurePessariesProgesteroncervical lengthPrevention
- Registration Number
- NL-OMON26394
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
one
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1020
Inclusion Criteria
1. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less (=35mm) OR
2. Multiple pregnancy and cervical length at 16 to 22 weeks of less than 38 mm (<38mm)
Exclusion Criteria
1. Cervical cerclage in this pregnancy
2. Maternal age less than 18 years
3. Identified major congenital abnormalities
4. Death of one or both of the foetuses
5. Previous spontaneous preterm birth before 34 weeks
6. Participation Quadruple P study in previous pregnancy
7. Cervical length < 2 mm
8. Cervical dilation >3cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite adverse neonatal outcome
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, birth weight, days of admission in neonatal intensive care unit, premature rupture of the membranes (PPROM), tocolysis (duration), use of corticosteroids, use of magnesium sulphate, mode of delivery, Twin Transfusion Syndrome (TTS), maternal morbidity, e.g. thrombo-embolic complications, infections, pneumonia, endometritis, eclampsia/HELLP, maternal death and admission days for preterm labour.<br>In addition, all components of the primary outcome will also be assessed separately as a secondary outcome measure. A cost-effectiveness analysis will be performed and reported separately from the primary trial results