NCT02716922

Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size

Conditions

• Preterm Birth

Interventions

Type	Name	Description
PROCEDURE	Cervical cerclage	Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-04-01
• Completion: 2019-03-01
• First posted: 2016-03-23
• Last updated: 2016-03-23

Locations

1 site across 1 country: Italy