LATe Cerclage in High-risk Pregnancies (LATCH) (LATCH)

May 27, 2026 updated by: Thomas Jefferson University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

329

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerclage
Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
Procedure: Cervical cerclage
Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
Other Names:
  • Cerclage
Drug: Vaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Other Names:
  • Vaginal progesterone
Other: Control
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Drug: Vaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Other Names:
  • Vaginal progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of preterm birth <37 weeks
Time Frame: At delivery
At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age at delivery
Time Frame: At delivery
At delivery
Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
Time Frame: At delivery
At delivery
Time interval from randomization to delivery
Time Frame: At delivery
At delivery
Incidence of preterm prelabor rupture of membranes (PPROM)
Time Frame: At occurrence up to 36 weeks and 6 days of gestation
At occurrence up to 36 weeks and 6 days of gestation
Neonatal outcomes: incidence of low birthweight (<2500g)
Time Frame: At delivery
At delivery
Neonatal outcomes: incidence of very low birthweight (<1500g)
Time Frame: At delivery
At delivery
Neonatal outcomes: incidence of admission to neonatal intensive care unit
Time Frame: At delivery
At delivery
Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality
Time Frame: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
Incidence of intraamniotic infection
Time Frame: At the time of delivery at any gestational age
Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature > 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [white blood cell count > 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [<15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation.
At the time of delivery at any gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Moti Gulersen, MD, MSc, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iRISID-2023-2321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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