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An Observational Study of Hepatitis C Virus in Pregnancy (HCV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by The George Washington University Biostatistics Center
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:
NCT01959321
First received: October 8, 2013
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
This multi-center observational study examines risk factors for HCV transmission from mother to baby.

Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Observational Study of Hepatitis C Virus in Pregnancy

Resource links provided by NLM:


Further study details as provided by The George Washington University Biostatistics Center:

Primary Outcome Measures:
  • HCV infection of the offspring [ Time Frame: 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:
  • Gestational age at delivery [ Time Frame: at birth ]
  • Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ]
  • Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ]
  • Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ]
  • Preeclampsia [ Time Frame: during pregnancy ]
  • Cholestasis [ Time Frame: during pregnancy ]
  • Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ]
  • HCV antibody status in infant [ Time Frame: at 18 months of age ]
    positive or negative

  • Birth weight of infant [ Time Frame: at birth ]
  • Hyperbilirubinemia [ Time Frame: at birth ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy

  • Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ]
  • Small for gestational age [ Time Frame: 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

  • Neonatal infections [ Time Frame: at birth ]
    sepsis and pneumonia


Biospecimen Retention:   Samples With DNA
maternal serum maternal plasma infant serum infant plasma

Estimated Enrollment: 1250
Study Start Date: October 2012
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Seropositive for Anti-HCV
Anti-HCV positive (includes seropositive viremic and seropositive non-viremic)
Seronegative for Anti-HCV
Anti-HCV negative

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with singleton pregnancies presenting for prenatal care prior to 23 weeks, 6 days gestation at Maternal-Fetal Medicine Units (MFMU) Network hospital sites.
Criteria

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. Eligible for the Maternal-Fetal Medicine Units (MFMU) Network Cytomegalovirus (CMV) trial (positive CMV Immunoglobulin M (IgM) and Immunoglobulin G (IgG) with low avidity) or potentially eligible (positive IgM, negative IgG)
  2. Planned termination of pregnancy
  3. Known major fetal anomalies or demise
  4. 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.
  5. Participation in this study in a previous pregnancy.
  6. Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959321

Contacts
Contact: Uma Reddy, MD 301-496-1074 uma.reddy@nih.gov

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262    stacylharris@uabmc.edu   
Principal Investigator: Alan TN Tita, MD         
United States, California
Stanford University Active, not recruiting
Stanford, California, United States, 94305-5317
United States, Colorado
University of Colorado Active, not recruiting
Denver, Colorado, United States, 80045
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN BSN CCRC    312-503-3200    g-mallett@northwestern.edu   
Principal Investigator: William Grobman, MD         
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States
Contact: Debra McLaud, RN    617-414-5813    debra.mclaud@bmc.org   
Principal Investigator: Steven Pelton, MD         
United States, New York
Columbia University Recruiting
New York City, New York, United States, 10032
Contact: Sabine Bousleiman, RNC MSN MPH    212-305-4348    sb1080@columbia.edu   
Principal Investigator: Ronald J Wapner, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M Thorp, Jr., MD         
Duke University Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RNC    216-778-7533    wdalton@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN, BSN    614-685-3229    anna.bartholomew@osumc.edu   
Principal Investigator: Catalin S Buhimschi, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Hammond, RN    215-662-2657    Mary.Hammond@uphs.upenn.edu   
Principal Investigator: Samuel Parry, MD         
Magee Women's Hospital of UPMC Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS, RN    412-641-4072    mbickus@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, MD, MS         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RNC    401-274-1122    dallard@wihri.org   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75235-9032
University of Texas - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN BSN    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Baha Sibai, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN    801-585-7645    Kim.Hill@hsc.utah.edu   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Uma Reddy, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth A Thom, PhD The George Washington University Biostatistics Center
Study Chair: Mona Prasad, DO, MPH Ohio State University
  More Information

Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01959321     History of Changes
Other Study ID Numbers: HD36801-HCV
U10HD036801 ( US NIH Grant/Contract Award Number )
UG1HD087230 ( US NIH Grant/Contract Award Number )
UG1HD027869 ( US NIH Grant/Contract Award Number )
UG1HD027915 ( US NIH Grant/Contract Award Number )
UG1HD034208 ( US NIH Grant/Contract Award Number )
UG1HD040500 ( US NIH Grant/Contract Award Number )
UG1HD040485 ( US NIH Grant/Contract Award Number )
UG1HD053097 ( US NIH Grant/Contract Award Number )
UG1HD040544 ( US NIH Grant/Contract Award Number )
UG1HD040545 ( US NIH Grant/Contract Award Number )
UG1HD040560 ( US NIH Grant/Contract Award Number )
UG1HD040512 ( US NIH Grant/Contract Award Number )
UG1HD068282 ( US NIH Grant/Contract Award Number )
UG1HD068258 ( US NIH Grant/Contract Award Number )
UG1HD068268 ( US NIH Grant/Contract Award Number )
UG1HD034116 ( US NIH Grant/Contract Award Number )
UG1HD087192 ( US NIH Grant/Contract Award Number )
Study First Received: October 8, 2013
Last Updated: March 7, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis C Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017