An Observational Study of Hepatitis C Virus in Pregnancy – (HCV)
IRB#: UNC: 12-1895, Wake: 364159
Approximately 3.2 million persons in the U.S are estimated to have chronic Hepatitis C Virus (HCV) infection. 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.
The purpose of this study is to understand risk factors associated with transmission of HCV from mom to baby and to try to determine if all women should be screened for HCV during pregnancy.
The screening part of this study can be done at your OB appointment. About a teaspoon of blood will be drawn for the antibody test, hopefully at the same time as your routine prenatal labs.
Is you are found to have been exposed to HCV, you may be approached by a research nurse to consent to a research study which will follow you and your baby. The study involves being followed with blood draws at various time points for you and your baby.
A group of pregnant women who have not been exposed to HCV will also be asked to join the study for comparison. Those women will be randomly chosen and will be asked to allow the research staff to collect information on their pregnancy and delivery, but they will not be asked for additional blood samples.
You may be qualified if the following applies to you:
- You are pregnant with one baby
- You have a positive HCV antibody on your screening test
- You have been randomly selected as an HCV antibody negative control
- You are less than 28 weeks pregnant
- You have had an ultrasound
You may not be able to participate if:
- You are participating in the CMV trial or are eligible to participate in the CMV but chose not to.
- You plan to terminate your pregnancy.
- Your baby has known serious abnormalities.
- You do not plan to deliver your baby at WakeMed or UNC Hospital Systems.
- You are unwilling or unable to commit to 18 months of follow-up for HCV positive infants
If you’re not sure if you qualify please contact us so we can help guide you.
Dates of Study
Fall 2013 to December 2018
This study is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Conducted by the NICHD Maternal-Fetal Medicine Units (MFMU). All biostatistical information is the responsibility of the Biostatistical Coordinating Center (BCC) at George Washington University.
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