RecruitingNot ApplicableNCT06122506

Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage


Sponsor

University of Aarhus

Enrollment

188 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Laparoscopic cerclage and a procedure called Vaginal cerclage for people with cervical insufficiency and preterm birth. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic cerclage

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

PROCEDUREVaginal cerclage

Transvaginal cerclage in pregnant women.


Locations(2)

Aarhus University Hospital

Aarhus N, Denmark

Rigshospitalet

Copenhagen, Denmark

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NCT06122506


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