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Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Sponsor: University of Aarhus
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 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2024-01-31
Completion Date
2028-03
Last Updated
2024-12-10
Healthy Volunteers
No
Conditions
Interventions
Laparoscopic cerclage
Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.
Vaginal cerclage
Transvaginal cerclage in pregnant women.
Locations (2)
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark