LATe Cerclage in High-risk Pregnancies (LATCH)
Start Date
11/10/2023
Completion Date
2/1/2029
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.
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 cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth \<37 weeks.
Eligibility Criteria
Age Range: 18 years to 50 years
Interventions
Cervical cerclage
Vaginal Suppository Progesterone
Conditions
Locations
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28204
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States