HCV in Pregnancy

Overview

Status: Recruiting
Keywords: Hepatitis C and pregnancy , HCV
IRB Number: 00059147
Specialty: Women and Children's Health
Sub Specialties:

Brief Summary

Approximately 3.2 million persons in the U.S are estimated to have chronic Hepatitis C Virus (HCV) infection.1 Chronic HCV infection may result in chronic liver disease, cirrhosis of the liver or, more rarely, death due to the consequences of chronic liver infection.

It is known that almost all cases of pediatric HCV are the result of transmission of the HCV infection from mother to baby. Studies suggest that the prevalence of HCV infection in pregnancy ranges from 0.6% to 2.4%. Several European studies suggest that the rate of mother to child transmission of HCV is 5% to 10%. However, it is unclear what percentage of these children will spontaneously clear the infection and what percentage will have persistent HCV infection. While maternal co-infection of HIV has emerged as a significant risk factor, study results regarding other possible risk factors associated with mother to child transmission have been mixed.

The purpose of this study is to understand risk factors associated with mother to child transmission of HCV.

 

Study Design Summary

The study is a multi-center observational cohort study of women at participating MFMU Network clinical centers. In addition selected centers of the NICHD International and Domestic Pediatric and Maternal HIV Studies Network will enroll patients into the HCV study. Women who have an HCV antibody positive screen, as determined by the test, before 236 weeks gestation will be eligible to enroll in the study. Approximately 1,200 seropositive viremic and 600 seropositive non-viremic women are expected to be enrolled in the study.

It is estimated that approximately 2,500 women who have an HCV antibody negative screen will be included in the control cohort. At MFMU Network sites, controls will be matched to case cohort patients by clinical center and gestational age +/- two weeks.

 

 

Principal Investigator: Michael Varner
Department: Maternal-Fetal Medicine
Co Investigator:

Contact Information

Name:Amber Sowles
Phone: 801-585-5499
Email: amber.sowles@hsc.utah.edu

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.

Gestational Age Determination

Gestational age is determined using criteria proposed by the American Congress of Obstetricians and Gynecologists, the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine and is denoted “project gestational age”. The “project EDC”, which is based on the project gestational age, cannot be revised once a determination has been made. In the case of in-vitro fertilization, project gestational age is calculated from the date of embryo transfer and the embryo age at transfer.

The following algorithm is used:

1. The first day of the last menstrual period (LMP) is determined, and a judgment made as to whether or not the patient has a “sure” LMP date.

2. If the LMP date is unsure, the ultrasound measurements obtained at the patient’s first dating ultrasound examination are used to determine the project gestational age. If the first dating ultrasound was conducted before 14 weeks 0 days, the measurement must be based on crown rump length (CRL).

3. If the LMP date is sure, project gestational age is determined by a comparison between the gestational age by LMP and by the earliest dating ultrasound.

  • If the earliest dating ultrasound confirms the gestational age by LMP within the number of days specified in Table 3 below, the LMP-derived gestational age is used to determine the project gestational age.

  • If the ultrasound determined gestational age does not confirm the LMP generated gestational age within the number of days specified in Table 3, the ultrasound is used to determine the project gestational age.

     

Table 3. Cutoffs for Using LMP to Determine Gestational Age for Sure LMP

Gestational age at first ultrasound by LMP

Ultrasound method of measurement

Ultrasound agreement with LMP

Up to 8 weeks 6 days

 

CRL

± 5 days

9 weeks 0 days to 13 weeks 6 days

 

CRL

± 7 days

14 weeks 0 days to 15 weeks 6 days

 

Per institution

± 7 days

16 weeks 0 days to 21 weeks 6 days

 

Per institution

± 10 days

22 weeks 0 days to 27 weeks 6 days

 

Per institution

± 14 days

 

Exclusion Criteria

1. Eligible for the CMV trial (positive CMV IgM and 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 participating Network center

5.  Participation in this study in a previous pregnancy. 

6. For the case cohort only: unwilling or unable to commit to 18 months of follow-up for HCV positive infants