An Observational Study of Hepatitis C Virus in Pregnancy
Trial ID or NCT#
NCT01959321
Status
RECRUITING
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
Eligibility Criteria
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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
Investigator(s)
Yasser El-Sayed, Professor
Obstetrician and Gynecologist (OB-GYN)
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
Contact us to find out if this trial is right for you.
Contact
Cynthia Willson, RN, BSN
650-724-6372
View on ClinicalTrials.gov
