PC-study
Recruiting
- Conditions
- preterm birthhistory of preterm birth short cervical length
- Registration Number
- NL-OMON26958
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
none
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 440
Inclusion Criteria
1) Singleton pregnancy
2) previous preterm birth < 34 weeks of gestation
AND
3)cervical length < 25mm or less on transvaginal ultrasound before 24 weeks of GA
OR
Indication for primary cerclage before 16 weeks in current pregnancy based on obstetric history, according to local protocol
Exclusion Criteria
1) Maternal age less than 18 years
2) Inability to give informed consent
3) Placenta praevia
4) Vasa praevia
5) Premature Prelabour Rupture of the Membranes (PPROM)
6) Cervical dilatation iY3cm
7) Cervical length 2mm
8) Identified major congenital abnormalities.
9) Women with clinical signs of chorioamnionitis or signs of intra uterine infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preterm birth < 32 weeks of gestation
- Secondary Outcome Measures
Name Time Method eonatal outcomes<br><br>Maternal outcomes