Cervical cerclage for preventing premature birth in high-risk pregnancies
Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
This study is testing if a procedure called cervical cerclage can help prevent early birth in pregnant people who are at high risk due to a short cervix.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 329 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06036446 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18-50 with singleton pregnancies and a cervical length of 25mm or less between 24 and 26 weeks of gestation.
Not a fit: Patients with multifetal pregnancies, active preterm labor, or other contraindications to cerclage placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of preterm births in high-risk pregnancies.
How similar studies have performed: Previous studies have shown varying degrees of success with cervical cerclage in preventing preterm birth, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania
- 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
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.