NCT06036446

LATe Cerclage in High-risk Pregnancies (LATCH)

Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 329 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
PROCEDURE	Cervical cerclage	Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
DRUG	Vaginal Suppository Progesterone	Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Timeline

• Start date: 2023-11-10
• Primary completion: 2028-10-01
• Completion: 2029-02-01
• First posted: 2023-09-14
• Last updated: 2025-04-16

Locations

1 site across 1 country: United States