An Observational Study of Hepatitis C Virus in Pregnancy

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

Detailed Description
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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.

Official Title
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An Observational Study of Hepatitis C Virus in Pregnancy

Conditions
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Hepatitis C

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV infection of the offspring | 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. | at 2 months and/or 18 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery |  | at birth | 
| Preterm delivery < 37 weeks of gestation |  | at birth | 
| Gestational diabetes mellitus (GDM) |  | during pregnancy | 
| Vaginal bleeding during pregnancy |  | during pregnancy | 
| Preeclampsia |  | during pregnancy | 
| Cholestasis |  | during pregnancy | 
| Viral load in infant |  | at birth, 2 months, and 18 months | 
| HCV antibody status in infant | positive or negative | at 18 months of age | 
| Birth weight of infant |  | at birth | 
| Hyperbilirubinemia | Peak total bilirubin of at least 15 mg% or the use of phototherapy | at birth | 
| Neonatal intensive care unit (NICU) admission |  | at birth | 
| Small for gestational age | 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 | at birth | 
| Neonatal infections | sepsis and pneumonia | at birth |