Status:
RECRUITING
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Rigshospitalet, Denmark
Viborg Regional Hospital
Conditions:
Preterm Birth
Cervical Insufficiency
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel be...
Detailed Description
Both vaginal and abdominal cerclages are procedures that have been used to prevent preterm birth for more than 50 years. However, only one previous study (MAVRIC, Shennan et al. 2020) has compared the...
Eligibility Criteria
Inclusion
- Women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth.
- Not yet pregnant or \<10 weeks' pregnant.
Exclusion
- Any circumstance under which the clinician is not willing to randomize is an exclusion criterion.
- Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks).
- Language difficulties.
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06122506
Start Date
January 31 2024
End Date
March 1 2028
Last Update
December 10 2024
Active Locations (2)
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1
Aarhus University Hospital
Aarhus N, Denmark
2
Rigshospitalet
Copenhagen, Denmark