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HCV: An Observational Study of Hepatitis C Virus in Pregnancy

Sponsor
The George Washington University Biostatistics Center (Other)
Overall Status
Completed
CT.gov ID
NCT01959321
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
772
Enrollment
17
Locations
104.9
Duration (Months)
45.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multi-center observational study examines risk factors for HCV transmission from mother to baby.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This multi-center observational study examines risk factors for HCV transmission from mother to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV) infection in pregnant women. Also, the study will describe the outcomes of pregnant women with HCV as well as the outcomes of their infants to 18 months of age.

    Approximately 750 HCV antibody positive pregnant women and their infants will be followed from baseline until the infant is 18 months. A randomly selected control cohort of 500 pregnant women who are HCV antibody negative will be followed until delivery.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    772 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of Hepatitis C Virus in Pregnancy
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. HCV infection of the offspring [at 2 months and/or 18 months of age]

      The primary outcome is HCV infection of the offspring, where infection is defined by satisfying any one of the following criteria: HCV RNA positive (i.e. presence of viral load) by polymerase chain reaction (PCR) test at 2-6 months (2 month visit) HCV RNA positive and HCV antibody positive at the 18-24 months (18 month visit) HCV RNA positive at 18-24 months with a negative HCV antibody at 18-24 months and negative RNA at 2-6 months. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify. HCV antibody positive at 18-24 months with negative HCV RNA at both visits. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify. Clinical result that is either HCV RNA positive or HCV antibody positive obtained at 18 months or older with a confirmed clinical diagnosis of HCV, if a central laboratory sample could not be obtained at 18-24 months.

    Secondary Outcome Measures

    1. Gestational age at delivery [at birth]

    2. Preterm delivery < 37 weeks of gestation [at birth]

    3. Gestational diabetes mellitus (GDM) [during pregnancy]

    4. Vaginal bleeding during pregnancy [during pregnancy]

    5. Preeclampsia [during pregnancy]

    6. Cholestasis [during pregnancy]

    7. Viral load in infant [at birth, 2 months, and 18 months]

    8. HCV antibody status in infant [at 18 months of age]

      positive or negative

    9. Birth weight of infant [at birth]

    10. Hyperbilirubinemia [at birth]

      Peak total bilirubin of at least 15 mg% or the use of phototherapy

    11. Neonatal intensive care unit (NICU) admission [at birth]

    12. Small for gestational age [at birth]

      Defined as less than the 5th percentile birth weight for gestational age at birth, assessed specifically by sex and race of the infant based on United States birth certificate data

    13. Neonatal infections [at birth]

      sepsis and pneumonia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Singleton pregnancy

    2. An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0.

    3. Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.

    Exclusion Criteria:

    1. Planned termination of pregnancy

    2. Known major fetal anomalies or demise

    3. Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age.

    4. Participation in this study in a previous pregnancy.

    5. Unwilling or unable to commit to 18 months of follow-up for HCV positive infants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama - Birmingham Birmingham Alabama United States 35233
    2 Stanford University Stanford California United States 94305-5317
    3 University of Colorado Denver Colorado United States 80045
    4 Northwestern University Chicago Illinois United States 60611
    5 Boston Medical Center Boston Massachusetts United States
    6 Columbia University New York New York United States 10032
    7 University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599
    8 Duke University Durham North Carolina United States 27710
    9 Case Western Reserve University Cleveland Ohio United States 44109
    10 Ohio State University Columbus Ohio United States 43210
    11 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    12 Magee Women's Hospital of UPMC Pittsburgh Pennsylvania United States 15213
    13 Brown University Providence Rhode Island United States 02905
    14 University of Texas Southwestern Medical Center Dallas Texas United States 75235-9032
    15 University of Texas - Galveston Galveston Texas United States 77555
    16 University of Texas - Houston Houston Texas United States 77030
    17 University of Utah Salt Lake City Utah United States 84132

    Sponsors and Collaborators

    • The George Washington University Biostatistics Center
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Study Director: Monica Longo, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    • Principal Investigator: Rebecca Clifton, PhD, The George Washington University Biostatistics Center
    • Study Chair: Mona Prasad, DO, MPH, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The George Washington University Biostatistics Center
    ClinicalTrials.gov Identifier:
    NCT01959321
    Other Study ID Numbers:
    • HD36801-HCV
    • U10HD036801
    • UG1HD087230
    • UG1HD027869
    • UG1HD027915
    • UG1HD034208
    • UG1HD040500
    • UG1HD040485
    • UG1HD053097
    • UG1HD040544
    • UG1HD040545
    • UG1HD040560
    • UG1HD040512
    • UG1HD068282
    • UG1HD068258
    • UG1HD068268
    • UG1HD034116
    • UG1HD087192
    First Posted:
    Oct 10, 2013
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis

    Study Results

    No Results Posted as of Jun 15, 2022