An Observational Study of Hepatitis C Virus in Pregnancy

Not Recruiting

Trial ID: NCT01959321

Purpose

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

Eligibility

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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Willson, RN, BSN
650-724-6372