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

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 772

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama - Birmingham
  • California
    • Stanford, California, United States, 94305-5317
      • Stanford University
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of UPMC
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Brown University
  • Texas
    • Dallas, Texas, United States, 75235-9032
      • University of Texas Southwestern Medical Center
    • Galveston, Texas, United States, 77555
      • University of Texas - Galveston
    • Houston, Texas, United States, 77030
      • University of Texas - Houston
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV infection of the offspring	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.	at 2 months and/or 18 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery		at birth
Preterm delivery < 37 weeks of gestation		at birth
Gestational diabetes mellitus (GDM)		during pregnancy
Vaginal bleeding during pregnancy		during pregnancy
Preeclampsia		during pregnancy
Cholestasis		during pregnancy
Viral load in infant		at birth, 2 months, and 18 months
HCV antibody status in infant	positive or negative	at 18 months of age
Birth weight of infant		at birth
Hyperbilirubinemia	Peak total bilirubin of at least 15 mg% or the use of phototherapy	at birth
Neonatal intensive care unit (NICU) admission		at birth
Small for gestational age	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	at birth
Neonatal infections	sepsis and pneumonia	at birth

Collaborators and Investigators

• Sponsor: The George Washington University Biostatistics Center
• Collaborators: 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); Study Chair: Mona Prasad, DO, MPH, Ohio State University; Principal Investigator: Rebecca Clifton, PhD, The George Washington University Biostatistics Center

Publications and helpful links

General Publications

• Prasad M, Saade GR, Sandoval G, Hughes BL, Reddy UM, Mele L, Salazar A, Varner MW, Gyamfi-Bannerman C, Thorp JM Jr, Tita ATN, Swamy GK, Chien EK, Casey BM, Peaceman AM, El-Sayed YY, Iams JD, Gibbs RS, Sibai B, Wiese N, Kamili S, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Hepatitis C Virus Antibody Screening in a Cohort of Pregnant Women: Identifying Seroprevalence and Risk Factors. Obstet Gynecol. 2020 Apr;135(4):778-788. doi: 10.1097/AOG.0000000000003754.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimated): October 10, 2013

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: HD36801-HCV; U10HD036801 (U.S. NIH Grant/Contract); UG1HD087230 (U.S. NIH Grant/Contract); UG1HD027869 (U.S. NIH Grant/Contract); UG1HD040500 (U.S. NIH Grant/Contract); UG1HD034208 (U.S. NIH Grant/Contract); UG1HD027915 (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); UG1HD087192 (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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses.