Official Title

Hepatitis C Virus Immunity in Women and Children

Purpose

This is a study to find out how pregnancy affects a mother’s immune system. (The “immune system” is the part of the body that fights germs.) This study is also to find out why some babies who are exposed to infections during pregnancy get infected and others do not.

To do this project we need to study some women and babies who are infected with the hepatitis C virus and others who are not. This will allow us to compare their immune systems.

Could this study be right for you?

You may be eligible to participate if you are:

PREGNANCY COHORT eligibility criteria:
1) Pregnant (enrollment preferably during 1st or 2nd trimester, but may occur as late as the delivery hospitalization)
2) HCV-RNA positive (#150) or HCV-RNA negative (#50)
3) Willing and able to attend all study visits

Exclusion criteria for mothers:
1) Inability to provide informed consent
2) Incarceration

Inclusion criteria for infants:
1) Child born to study mother

Exclusion criteria for infants:
1) In custody of county children’s services (Enrolled infants who are temporarily in custody of children’s services will not have further study blood draws, but lab results from blood tests ordered by their pediatrician may be followed to monitor the outcome of their HCV exposure. Infants who are later placed back in the custody of their mother or relative may be re-enrolled.)

NON-PREGNANCY COHORT eligibility criteria:
1) Willing and able to attend all study visits

Exclusion criteria:
1) Currently pregnant
2) Inability to provide informed consent
3) Incarceration