NCT06122506 Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
| NCT ID | NCT06122506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2024-01-31 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Niels Uldbjerg, DMSc
STUDY DIRECTOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06122506 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06122506 currently recruiting?
Yes, NCT06122506 is actively recruiting participants. Contact the research team at lea.hansen@clin.au.dk for enrollment information.
Where is the NCT06122506 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT06122506 clinical trial?
NCT06122506 is sponsored by University of Aarhus. The principal investigator is Niels Uldbjerg, DMSc at Aarhus University Hospital. The trial plans to enroll 188 participants.