Cervical cerclage for preventing premature birth in high-risk pregnancies

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 clinical trial aims to evaluate the effectiveness of cervical cerclage in reducing the risk of preterm birth among singleton pregnancies identified as high-risk due to a short cervical length of 25mm or less. Pregnant individuals between 24 and 26 weeks of gestation will be screened and randomized to receive either cervical cerclage or no cerclage, while all participants will also be recommended to use vaginal progesterone. The primary outcome measured will be the incidence of preterm birth before 37 weeks of gestation. This approach seeks to provide a potential intervention for those at significant risk of early delivery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-50 years old, pregnant, assigned female at birth
* Singleton pregnancy
* TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation

Exclusion Criteria:

* Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed \>14 weeks, or cotwin pregnancy loss diagnosed \>14 weeks
* Cerclage in situ
* Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
* PPROM
* Active vaginal bleeding
* Suspected intraamniotic infection
* Major fetal structural abnormality or chromosomal disorder
* Placenta previa or accreta
* Other contraindication to cerclage placement
* Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone

Where it's running

• Atrium Health Carolinas Medical Center
  Charlotte, North Carolina, United States Recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Moti Gulersen, MD, MSc — Thomas Jefferson University
• Study coordinator: Moti Gulersen, MD, MSc
• Email: moti.gulersen@jefferson.edu
• Phone: 215-955-5000

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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.