Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Recruiting now · Not applicable
Conditions studied: Preterm Birth, Cervical Insufficiency
In brief
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 facts
- Study ID
- NCT06122506
- Run by
- University of Aarhus
- People needed
- 188
- Starts
- 2024-01-31
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2024-12-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Aarhus University Hospital — Aarhus N, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
Full record on ClinicalTrials.gov
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