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RECRUITING
NCT05968794
NA

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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2023-05-15

Completion Date

2028-12-01

Last Updated

2023-11-13

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (13)

University Medical Center Antwerpen

Antwerp, Belgium

University Medical Center Sint-Lucas Brugge

Bruges, Belgium

Hospital Oost-Limburg Genk

Genk, Belgium

University Medical Center Gent

Ghent, Belgium

University Medical Center Leuven

Leuven, Belgium

University Medical Center Amsterdam

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

University Medical Center Leiden

Leiden, Netherlands

University Medical Center Maastricht

Maastricht, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Erasmus Medical Centre

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Maxima Medical Centre

Veldhoven, Netherlands