An Observational Study of Hepatitis C Virus in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01959321
First received: October 8, 2013
Last updated: May 8, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • HCV infection of the offspring [ Time Frame: at 2 months and/or 18 months of age ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Gestational age at delivery [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Preeclampsia [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Cholestasis [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ] [ Designated as safety issue: No ]
  • HCV antibody status in infant [ Time Frame: at 18 months of age ] [ Designated as safety issue: No ]
    positive or negative

  • Birth weight of infant [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Hyperbilirubinemia [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy

  • Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
  • Small for gestational age [ Time Frame: at birth ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    sepsis and pneumonia


Biospecimen Retention:   Samples With DNA

maternal serum maternal plasma infant serum infant plasma


Estimated Enrollment: 1800
Study Start Date: October 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: October 2018 (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 1,800 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 3,600 pregnant women who are HCV antibody negative will be followed until delivery.

  Eligibility

Genders 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) OR a randomly selected HCV antibody negative screen (control) matched to a case patient by project gestational age (see below) +/- 2 weeks and clinical center site. HCV antibody screen will be 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 236 weeks and gestational age at enrollment no later than 276 weeks, 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
  5. For the case cohort only: 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 Recruiting
Stanford, California, United States, 94305-5317
Contact: Karin Kushniruk, RN, PhD    650-724-0395    karink1@stanford.edu   
Principal Investigator: Yasser El-Sayed, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Kathy Hale, RN BSN    303-724-6685    kathy.a.hale@ucdenver.edu   
Principal Investigator: Ronald Gibbs, MD         
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: Alan M Peaceman, 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 Recruiting
Durham, North Carolina, United States, 27710
Contact: Tammy S Bishop, RNC MSN    919-668-7475    sincl008@mc.duke.edu   
Principal Investigator: Geeta K Swamy, MD         
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: Francee Johnson, BSN    614-293-5632    johnson.126@osu.edu   
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Francee Johnson, RN    614-293-5632    johnson.126@osu.edu   
Principal Investigator: Jay D Iams, MD         
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 Recruiting
Dallas, Texas, United States, 75235-9032
Contact: Lisa Moseley, RN    214-648-2591    lisa.moseley@utsouthwestern.edu   
Principal Investigator: Brian M Casey, MD         
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
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

No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01959321     History of Changes
Other Study ID Numbers: HD36801
Study First Received: October 8, 2013
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014