An Observational Study of Hepatitis C Virus in Pregnancy

N/ACompletedNCT01959321

The George Washington University Biostatistics Center772 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

772

Conditions

Hepatitis C

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (17)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

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.

Time frame: at 2 months and/or 18 months of age

Secondary Outcomes

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

Data from ClinicalTrials.gov

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