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Recruiting NCT06036446

NCT06036446 LATe Cerclage in High-risk Pregnancies (LATCH)

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Clinical Trial Summary
NCT ID NCT06036446
Status Recruiting
Phase
Sponsor Thomas Jefferson University
Condition Premature Birth
Study Type INTERVENTIONAL
Enrollment 329 participants
Start Date 2023-11-10
Primary Completion 2028-10

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 50 Years
Study Type INTERVENTIONAL
Interventions
Cervical cerclageVaginal Suppository Progesterone

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 329 participants in total. It began in 2023-11-10 with a primary completion date of 2028-10.

⚠ 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

The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.

Eligibility 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

Contact & Investigator

Central Contact

Moti Gulersen, MD, MSc

✉ moti.gulersen@jefferson.edu

📞 215-955-5000

Principal Investigator

Moti Gulersen, MD, MSc

PRINCIPAL INVESTIGATOR

Thomas Jefferson University

Frequently Asked Questions

Who can join the NCT06036446 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06036446 currently recruiting?

Yes, NCT06036446 is actively recruiting participants. Contact the research team at moti.gulersen@jefferson.edu for enrollment information.

Where is the NCT06036446 trial being conducted?

This trial is being conducted at Charlotte, United States, Philadelphia, United States.

Who is sponsoring the NCT06036446 clinical trial?

NCT06036446 is sponsored by Thomas Jefferson University. The principal investigator is Moti Gulersen, MD, MSc at Thomas Jefferson University. The trial plans to enroll 329 participants.

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