Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor.
Suspended
- Conditions
- Pregnancy, Preterm birth, Threatened preterm labor, Pessary
- Registration Number
- NL-OMON28719
- Lead Sponsor
- Academic Medical Center AmsterdamMeibergdreef 9Postbus 22660 1100 DD AmsterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
singleton/twin pregnancy
-GA between 24+0 and 34+6 weeks
- Cervical length >15mm-<30mm and positive fibronectin
- undelivered after 48 hours
Exclusion Criteria
-major fetal abnormalities
-signs of intra-uterine infection
-ruptured membranes
-cervical dilatation > 3cm
-Residual cervical length that makes it impossible to place a pessary
-randomisation >72 hours after becoming eligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preterm delivery <37 weeks of gestation.
- Secondary Outcome Measures
Name Time Method eonatal outcomes; composite of neonatal morbidity (e.g. RDS, BPD, IVH, NEC, PVL, sepsis) and death.<br>Delivery outcomes: e.g. GA at delivery, time to delivery and preterm birth rates <34 and <32 weeks. <br>Maternal outcomes: side-effects, complications of pessary