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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01959321
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : March 1, 2018
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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

Condition or disease
Hepatitis C

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 Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: An Observational Study of Hepatitis C Virus in Pregnancy
Study Start Date : October 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. Gestational age at delivery [ Time Frame: at birth ]
  2. Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ]
  3. Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ]
  4. Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ]
  5. Preeclampsia [ Time Frame: during pregnancy ]
  6. Cholestasis [ Time Frame: during pregnancy ]
  7. Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ]
  8. HCV antibody status in infant [ Time Frame: at 18 months of age ]
    positive or negative

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

  11. Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ]
  12. 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

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

Biospecimen Retention:   None Retained
maternal serum maternal plasma infant serum infant plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01959321

Contact: Uma Reddy, MD 301-496-1074

United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, BSN    205-996-6262   
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   
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   
Principal Investigator: Steven Pelton, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, RNC MSN MPH    212-305-4348   
Principal Investigator: Cynthia Gymafi-Bannerman, 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   
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   
Principal Investigator: Edward Chien, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN, BSN    614-685-3229   
Principal Investigator: Catalin S Buhimschi, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Hammond, RN    215-662-2657   
Principal Investigator: Samuel Parry, MD         
Magee Women's Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS, RN    412-641-4072   
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   
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   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN BSN    713-500-6467   
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   
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)
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

Responsible Party: The George Washington University Biostatistics Center Identifier: NCT01959321     History of Changes
Other Study ID Numbers: HD36801-HCV
U10HD036801 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD027869 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD068282 ( U.S. NIH Grant/Contract )
UG1HD068258 ( U.S. NIH Grant/Contract )
UG1HD068268 ( U.S. NIH Grant/Contract )
UG1HD034116 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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

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