Comparing laparoscopic and vaginal cerclage for preventing preterm birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.