Actively Recruiting
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Led by University of Aarhus · Updated on 2024-12-10
188
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy. To evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England
CONDITIONS
Official Title
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 10 weeks pregnant.
You will not qualify if you...
- Any circumstance under which the clinician is not willing to randomize.
- Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated, including ongoing pregnancy of more than 10 weeks gestation.
- Language difficulties.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus N, Denmark
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
L
Lea K Hansen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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