Status:
RECRUITING
LATe Cerclage in High-risk Pregnancies (LATCH)
Lead Sponsor:
Thomas Jefferson University
Conditions:
Premature Birth
Eligibility:
FEMALE
18-50 years
Phase:
NA
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...
Detailed Description
Singleton high-risk pregnancies \< 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT06036446
Start Date
November 10 2023
End Date
February 1 2029
Last Update
April 16 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107