NCT06036446

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2023Feb 2029

First Submitted

Initial submission to the registry

August 18, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

4.9 years

First QC Date

August 18, 2023

Last Update Submit

April 11, 2025

Conditions

Premature Birth

Keywords

Cervical lengthShort cervixShortened cervixPrematurityPreterm birthViability

Outcome Measures

Primary Outcomes (1)

  • Incidence of preterm birth <37 weeks

    At delivery

Secondary Outcomes (9)

  • Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks

    At delivery

  • Gestational age at delivery

    At delivery

  • Time interval from randomization to delivery

    At delivery

  • Incidence of preterm prelabor rupture of membranes (PPROM)

    At occurrence up to 36 weeks and 6 days of gestation

  • Incidence of intraamniotic infection

    At the time of delivery at any gestational age

  • +4 more secondary outcomes

Study Arms (2)

Cerclage

EXPERIMENTAL

Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.

Procedure: Cervical cerclageDrug: Vaginal Suppository Progesterone

Control

OTHER

Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Drug: Vaginal Suppository Progesterone

Interventions

Cervical cerclagePROCEDURE

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

Also known as: Cerclage
Cerclage
Vaginal Suppository ProgesteroneDRUG

Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Also known as: Vaginal progesterone
CerclageControl

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old, pregnant, assigned female at birth
  • Singleton pregnancy
  • TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.

    PMID: 36924844BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Cerclage, Cervical

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Moti Gulersen, MD, MSc

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moti Gulersen, MD, MSc

CONTACT

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

Vincenzo Berghella, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 14, 2023

Study Start

November 10, 2023

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations

US(1)