LATe Cerclage in High-risk Pregnancies (LATCH)

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Thomas Jefferson University
Study ID
NCT06036446
Status
Recruiting
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Conditions

  • Premature Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
May 2026
Primary completion
Oct 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
329 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cerclage
    Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
  • Other: Control
    Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Primary Outcome Measure

Incidence of preterm birth <37 weeks [ Time Frame: At delivery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28204
Lorene Temming, MD, MSCI
[email protected]
704-448-0305
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Moti Gulersen, MD, MSc
[email protected]
215-955-5000

Find similar trials in Charlotte, NC

By research site
Atrium Health Carolinas Medical Center· Charlotte, NCThomas Jefferson University· Philadelphia, PA

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