An Observational Study of Hepatitis C Virus in Pregnancy



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/14/2019
Start Date:October 2012
End Date:July 2021

Use our guide to learn which trials are right for you!

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

This multi-center observational study examines risk factors for HCV transmission from mother
to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV)
infection in pregnant women. Also, the study will describe the outcomes of pregnant women
with HCV as well as the outcomes of their infants to 18 months of age.

Approximately 750 HCV antibody positive pregnant women and their infants will be followed
from baseline until the infant is 18 months. A randomly selected control cohort of 500
pregnant women who are HCV antibody negative will be followed until delivery.

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
We found this trial at
17
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Michael W Varner, MD
Phone: 801-585-7645
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Alan TN Tita, MD
Phone: 205-996-6262
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: John M Thorp, Jr., MD
Phone: 919-350-6117
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Geeta K Swamy, MD
Phone: 919-668-7475
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Cynthia Gymafi-Bannerman, MD
Phone: 212-305-4348
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
?
mi
from
New York, NY
Click here to add this to my saved trials
Boston, Massachusetts 02118
Principal Investigator: Steven Pelton, MD
Phone: 617-414-5813
?
mi
from
Boston, MA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: William Grobman, MD
Phone: 312-503-3200
?
mi
from
Chicago, IL
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Edward Chien, MD
Phone: 216-778-7533
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Catalin S Buhimschi, MD
Phone: 614-685-3229
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Brian M Casey, MD
Phone: 214-648-2591
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80210
Principal Investigator: Ronald Gibbs, MD
Phone: 303-724-6685
?
mi
from
Denver, CO
Click here to add this to my saved trials
Galveston, Texas 77555
Principal Investigator: George R Saade, MD
Phone: 409-772-0312
?
mi
from
Galveston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Baha Sibai, MD
Phone: 713-500-6467
?
mi
from
Houston, TX
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Samuel Parry, MD
Phone: 215-662-2657
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Hyagriv Simhan, MD, MS
Phone: 412-641-4072
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Dwight J Rouse, MD
Phone: 401-274-1122
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
?
mi
from
Providence, RI
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Yasser El-Sayed, MD
Phone: 650-724-6372
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials