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RECRUITING
NCT06122506
NA

Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Laparoscopic cerclage

Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.

PROCEDURE

Vaginal cerclage

Transvaginal cerclage in pregnant women.

Locations (2)

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark