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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959321
Recruitment Status : Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : February 27, 2020
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

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.

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Study Type : Observational
Actual Enrollment : 772 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:   Samples With DNA
maternal serum maternal plasma infant serum infant plasma cord blood plasma cord blood buffy coat


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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.
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. 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 ClinicalTrials.gov identifier (NCT number): NCT01959321


Locations
Show Show 17 study locations
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Director: Caroline Signore, M.D., MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center
Study Chair: Mona Prasad, DO, MPH Ohio State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01959321    
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: February 27, 2020
Last Verified: February 2020
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 mfmudatasets@bsc.gwu.edu.
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections