Comparing laparoscopic and vaginal cerclage for preventing preterm birth
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
This study is testing whether a laparoscopic or vaginal stitch can better help women with weak cervixes prevent early births.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus N and 1 other locations) |
| Trial ID | NCT06122506 on ClinicalTrials.gov |
What this trial studies
This trial aims to determine the most effective method for preventing preterm birth in women with cervical insufficiency by comparing laparoscopic cerclage and vaginal cerclage. Women at risk will be randomly assigned to receive either type of cerclage before pregnancy or early in pregnancy. The study will include participants from Nordic countries and England, with a total of 188 women targeted for enrollment. The primary outcomes will focus on the rates of delivery before 32 weeks of gestation and infant mortality.
Who should consider this trial
Good fit: Ideal candidates are women who are not yet pregnant or are less than 10 weeks pregnant and for whom the clinician is uncertain whether vaginal or laparoscopic cerclage is the best option.
Not a fit: Patients who are already more than 10 weeks pregnant or have contraindications for either type of cerclage will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the best surgical approach to prevent preterm birth, potentially improving outcomes for mothers and infants.
How similar studies have performed: Previous studies, such as the MAVRIC trial, have shown some success in comparing these approaches, but this trial aims to provide more definitive answers.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus N and 1 other locations
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Julie Glavind, MD, PhD — Aarhus University Hospital
- Study coordinator: Lea K Hansen, MD
- Email: lea.hansen@clin.au.dk
- Phone: +45 51910993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.