NCT02708264

Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DEVICE	Cervical pessary	The cervical pessary is a silicone device that has been used to prevent SPTB

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-01-01
• Completion: 2021-03-01
• First posted: 2016-03-15
• Last updated: 2018-11-16

Locations

1 site across 1 country: Italy