LATe Cerclage in High-risk Pregnancies (LATCH)

Thomas Jefferson University329 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

329

Conditions

Premature Birth

Interventions

Cervical cerclagePROCEDURE

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

Vaginal Suppository ProgesteroneDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of preterm birth <37 weeks

Time frame: At delivery

Secondary Outcomes

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

Time frame: At delivery

Gestational age at delivery

Time frame: At delivery

Time interval from randomization to delivery

Time frame: At delivery

Incidence of preterm prelabor rupture of membranes (PPROM)

Time frame: At occurrence up to 36 weeks and 6 days of gestation

Incidence of intraamniotic infection

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.

Time frame: At the time of delivery at any gestational age

Neonatal outcomes: incidence of low birthweight (<2500g)

Time frame: At delivery

Neonatal outcomes: incidence of very low birthweight (<1500g)

Time frame: At delivery

Neonatal outcomes: incidence of admission to neonatal intensive care unit

Time frame: At delivery

Central Contacts

Moti Gulersen, MD, MSc

CONTACT

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

Vincenzo Berghella, MD

CONTACT

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

Data from ClinicalTrials.gov

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