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Completed

NCT Number: NCT01959321

An Observational Study of Hepatitis C Virus in Pregnancy

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy
  • 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.
  • 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

  • Planned termination of pregnancy
  • Known major fetal anomalies or demise
  • 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.
  • Participation in this study in a previous pregnancy.
  • Unwilling or unable to commit to 18 months of follow-up for HCV positive infants

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The George Washington University Biostatistics Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: HCV

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2013
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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