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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)
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
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