NCT05968794

Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation

The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age. The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age? Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.

Detailed description

Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at \< 28 weeks per year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking. Objective: To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth \< 28 weeks of gestational age. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. The results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. If proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
PROCEDURE	Vaginal cerclage	A vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency.

Timeline

• Start date: 2023-05-15
• Primary completion: 2028-01-01
• Completion: 2028-12-01
• First posted: 2023-08-01
• Last updated: 2023-11-13

Locations

13 sites across 2 countries: Belgium, Netherlands