An Observational Study of Hepatitis C Virus in Pregnancy


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Trial ID: NCT01959321


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

Official Title

An Observational Study of Hepatitis C Virus in Pregnancy

Stanford Investigator(s)

Yasser El-Sayed, Professor
Yasser El-Sayed, Professor

Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery


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


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Willson, RN, BSN