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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by The George Washington University Biostatistics Center
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
ClinicalTrials.gov Identifier:
NCT01959321
First received: October 8, 2013
Last updated: March 7, 2017
Last verified: March 2017

October 8, 2013
March 7, 2017
October 2012
December 2020   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01959321 on ClinicalTrials.gov Archive Site
  • Gestational age at delivery [ Time Frame: at birth ]
  • Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ]
  • Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ]
  • Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ]
  • Preeclampsia [ Time Frame: during pregnancy ]
  • Cholestasis [ Time Frame: during pregnancy ]
  • Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ]
  • HCV antibody status in infant [ Time Frame: at 18 months of age ]
    positive or negative
  • Birth weight of infant [ Time Frame: at birth ]
  • Hyperbilirubinemia [ Time Frame: at birth ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy
  • Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ]
  • 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
  • Neonatal infections [ Time Frame: at birth ]
    sepsis and pneumonia
Same as current
Not Provided
Not Provided
 
An Observational Study of Hepatitis C Virus in Pregnancy
An Observational Study of Hepatitis C Virus in Pregnancy
This multi-center observational study examines risk factors for HCV transmission from mother to baby.

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.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
maternal serum maternal plasma infant serum infant plasma
Non-Probability Sample
Women with singleton pregnancies presenting for prenatal care prior to 23 weeks, 6 days gestation at Maternal-Fetal Medicine Units (MFMU) Network hospital sites.
Hepatitis C
Not Provided
  • Seropositive for Anti-HCV
    Anti-HCV positive (includes seropositive viremic and seropositive non-viremic)
  • Seronegative for Anti-HCV
    Anti-HCV negative
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1250
July 2021
December 2020   (Final data collection date for primary outcome measure)

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. 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, unless special provisions are made to insure infant follow-up at two and 18 months of age.
  5. Participation in this study in a previous pregnancy.
  6. Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Uma Reddy, MD 301-496-1074 uma.reddy@nih.gov
United States
 
 
NCT01959321
HD36801-HCV
U10HD036801 ( US NIH Grant/Contract Award Number )
UG1HD087230 ( US NIH Grant/Contract Award Number )
UG1HD027869 ( US NIH Grant/Contract Award Number )
UG1HD027915 ( US NIH Grant/Contract Award Number )
UG1HD034208 ( US NIH Grant/Contract Award Number )
UG1HD040500 ( US NIH Grant/Contract Award Number )
UG1HD040485 ( US NIH Grant/Contract Award Number )
UG1HD053097 ( US NIH Grant/Contract Award Number )
UG1HD040544 ( US NIH Grant/Contract Award Number )
UG1HD040545 ( US NIH Grant/Contract Award Number )
UG1HD040560 ( US NIH Grant/Contract Award Number )
UG1HD040512 ( US NIH Grant/Contract Award Number )
UG1HD068282 ( US NIH Grant/Contract Award Number )
UG1HD068258 ( US NIH Grant/Contract Award Number )
UG1HD068268 ( US NIH Grant/Contract Award Number )
UG1HD034116 ( US NIH Grant/Contract Award Number )
UG1HD087192 ( US NIH Grant/Contract Award Number )
No
Not Provided
Yes
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.
The George Washington University Biostatistics Center
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
The George Washington University Biostatistics Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP