An Observational Study of Hepatitis C Virus in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01959321
First received: October 8, 2013
Last updated: May 8, 2014
Last verified: March 2014

October 8, 2013
May 8, 2014
October 2012
October 2018   (final data collection date for primary outcome measure)
HCV infection of the offspring [ Time Frame: at 2 months and/or 18 months of age ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01959321 on ClinicalTrials.gov Archive Site
  • Gestational age at delivery [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Preeclampsia [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Cholestasis [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
  • Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ] [ Designated as safety issue: No ]
  • HCV antibody status in infant [ Time Frame: at 18 months of age ] [ Designated as safety issue: No ]
    positive or negative
  • Birth weight of infant [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Hyperbilirubinemia [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy
  • Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
  • Small for gestational age [ Time Frame: at birth ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    sepsis and pneumonia
Same as current
Not Provided
Not Provided
 
An Observational Study of Hepatitis C Virus in Pregnancy
Not Provided

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 1,800 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 3,600 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
1800
April 2019
October 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Singleton pregnancy
  2. An HCV antibody positive screen (case) OR a randomly selected HCV antibody negative screen (control) matched to a case patient by project gestational age (see below) +/- 2 weeks and clinical center site. HCV antibody screen will be 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 236 weeks and gestational age at enrollment no later than 276 weeks, 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
  5. For the case cohort only: unwilling or unable to commit to 18 months of follow-up for HCV positive infants
Female
Not Provided
No
Contact: Uma Reddy, MD 301-496-1074 uma.reddy@nih.gov
United States
 
NCT01959321
HD36801
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2014

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