Recruiting

LATe Cerclage

Sponsor:

Thomas Jefferson University

Code:

NCT06036446

Conditions

Premature Birth

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Cervical cerclage

Vaginal Suppository Progesterone

Study Details

Brief 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.

Conditions

Premature Birth

Study ID

NCT06036446

Start date

Nov 10, 2023

Status verified date

May, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

329 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cervical cerclage

Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.

Vaginal Suppository Progesterone

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 and Locations

Central contacts

Moti Gulersen, MD, MSc

215-955-5000moti.gulersen@jefferson.edu

Vincenzo Berghella, MD

215-955-5000vincenzo.berghella@jefferson.edu

Locations

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Lorene Temming, MD, MSCI

704-448-0305Lorene.Temming@advocatehealth.org

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Moti Gulersen, MD, MSc

215-955-5000moti.gulersen@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Cervical length
  • Short cervix
  • Shortened cervix
  • Prematurity
  • Preterm birth
  • Viability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-05-29.