NCT03591042

Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth

Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,334 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cervical length screening	transvaginal ultrasound cervical length

Timeline

• Start date: 2018-07-21
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2018-07-18
• Last updated: 2021-04-06

Locations

2 sites across 1 country: Italy