RecruitingNot ApplicableNCT06036446

LATe Cerclage in High-risk Pregnancies (LATCH)

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


Sponsor

Thomas Jefferson University

Enrollment

329 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

  • -50 years old, pregnant, assigned female at birth
  • Singleton pregnancy
  • TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation

Exclusion Criteria10

  • 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

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Interventions

PROCEDURECervical cerclage

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

DRUGVaginal Suppository Progesterone

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


Locations(1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

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NCT06036446


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