An Observational Study of Hepatitis C Virus in Pregnancy
- Conditions
- Hepatitis C
- Registration Number
- NCT01959321
- Lead Sponsor
- The George Washington University Biostatistics Center
- Brief Summary
This multi-center observational study examines risk factors for HCV transmission from mother to baby.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 772
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HCV infection of the offspring 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
Name Time Method Gestational diabetes mellitus (GDM) during pregnancy Preeclampsia during pregnancy Birth weight of infant at birth Small for gestational age 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
Vaginal bleeding during pregnancy during pregnancy Cholestasis during pregnancy HCV antibody status in infant at 18 months of age positive or negative
Neonatal intensive care unit (NICU) admission at birth Neonatal infections at birth sepsis and pneumonia
Gestational age at delivery at birth Viral load in infant at birth, 2 months, and 18 months Hyperbilirubinemia at birth Peak total bilirubin of at least 15 mg% or the use of phototherapy
Preterm delivery < 37 weeks of gestation at birth
Trial Locations
- Locations (17)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Brown University
🇺🇸Providence, Rhode Island, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Duke University
🇺🇸Durham, North Carolina, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Columbia University
🇺🇸New York, New York, United States
Stanford University
🇺🇸Stanford, California, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of Texas - Galveston
🇺🇸Galveston, Texas, United States
University of Texas - Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States