RECRUITING

LATe Cerclage in High-risk Pregnancies (LATCH)

Conditions

Premature Birth Cervical length Short cervix Shortened cervix Prematurity Preterm birth Viability

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-10

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06036446

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Moti Gulersen, MD, MSc

CONTACT

215-955-5000

moti.gulersen@jefferson.edu

Vincenzo Berghella, MD

CONTACT

215-955-5000

vincenzo.berghella@jefferson.edu

Principal Investigator

Moti Gulersen, MD, MSc

PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Study Locations (Sites)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Moti Gulersen, MD, MSc, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

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 Registration Dates

Study Start Date2023-11-10

Study Completion Date2027-02

Study Record Updates

Study Start Date2023-11-10

Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

Cervical length
Short cervix
Shortened cervix
Prematurity
Preterm birth
Viability

Additional Relevant MeSH Terms

Premature Birth