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LATe Cerclage in High-risk Pregnancies (LATCH) (LATCH)

Primary Purpose

Premature Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical cerclage
Vaginal Suppository Progesterone
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Cerclage

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Incidence of preterm birth <37 weeks

    Secondary Outcome Measures

    Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
    Gestational age at delivery
    Time interval from randomization to delivery
    Incidence of preterm prelabor rupture of membranes (PPROM)
    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.
    Neonatal outcomes: incidence of low birthweight (<2500g)
    Neonatal outcomes: incidence of very low birthweight (<1500g)
    Neonatal outcomes: incidence of admission to neonatal intensive care unit
    Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality

    Full Information

    First Posted
    August 18, 2023
    Last Updated
    September 29, 2023
    Sponsor
    Thomas Jefferson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06036446
    Brief Title
    LATe Cerclage in High-risk Pregnancies (LATCH)
    Acronym
    LATCH
    Official Title
    Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2026 (Anticipated)
    Study Completion Date
    February 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Thomas Jefferson University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 cervical length (TVU CL, ≤25mm) between 24 0/7-26 6/7 weeks.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Birth
    Keywords
    Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    329 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cerclage
    Arm Type
    Experimental
    Arm Description
    Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cervical cerclage
    Other Intervention Name(s)
    Cerclage
    Intervention Description
    Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
    Intervention Type
    Drug
    Intervention Name(s)
    Vaginal Suppository Progesterone
    Other Intervention Name(s)
    Vaginal progesterone
    Intervention Description
    Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
    Primary Outcome Measure Information:
    Title
    Incidence of preterm birth <37 weeks
    Time Frame
    At delivery
    Secondary Outcome Measure Information:
    Title
    Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
    Time Frame
    At delivery
    Title
    Gestational age at delivery
    Time Frame
    At delivery
    Title
    Time interval from randomization to delivery
    Time Frame
    At delivery
    Title
    Incidence of preterm prelabor rupture of membranes (PPROM)
    Time Frame
    At occurrence up to 36 weeks and 6 days of gestation
    Title
    Incidence of intraamniotic infection
    Description
    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
    Title
    Neonatal outcomes: incidence of low birthweight (<2500g)
    Time Frame
    At delivery
    Title
    Neonatal outcomes: incidence of very low birthweight (<1500g)
    Time Frame
    At delivery
    Title
    Neonatal outcomes: incidence of admission to neonatal intensive care unit
    Time Frame
    At delivery
    Title
    Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality
    Time Frame
    At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moti Gulersen, MD, MSc
    Phone
    215-955-5000
    Email
    moti.gulersen@jefferson.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincenzo Berghella, MD
    Phone
    215-955-5000
    Email
    vincenzo.berghella@jefferson.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Moti Gulersen, MD, MSc
    Organizational Affiliation
    Thomas Jefferson University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36924844
    Citation
    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.
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    LATe Cerclage in High-risk Pregnancies (LATCH)

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