An Observational Study of Hepatitis C Virus in Pregnancy

Hepatitis C Clinical Trial

— HCV  

Official title:

An Observational Study of Hepatitis C Virus in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959321
• Other study ID #: HD36801-HCV
• Secondary ID: U10HD036801UG1HD
• Status: Completed
• Start date: October 2012
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2024
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 772
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Texas - Galveston	Galveston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	Columbia University	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Magee Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Brown University	Providence	Rhode Island
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV infection of the offspring	The primary outcome is HCV infection of the offspring, where infection is defined by satisfying any one of the following criteria: HCV RNA positive (i.e. presence of viral load) by polymerase chain reaction (PCR) test at 2-6 months (2 month visit); HCV RNA positive and HCV antibody positive at the 18-24 months (18 month visit); HCV RNA positive at 18-24 months with a negative HCV antibody at 18-24 months and negative RNA at 2-6 months. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify.; HCV antibody positive at 18-24 months with negative HCV RNA at both visits. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify.; Clinical result that is either HCV RNA positive or HCV antibody positive obtained at 18 months or older with a confirmed clinical diagnosis of HCV, if a central laboratory sample could not be obtained at 18-24 months.	at 2 months and/or 18 months of age
Secondary	Gestational age at delivery		at birth
Secondary	Preterm delivery < 37 weeks of gestation		at birth
Secondary	Gestational diabetes mellitus (GDM)		during pregnancy
Secondary	Vaginal bleeding during pregnancy		during pregnancy
Secondary	Preeclampsia		during pregnancy
Secondary	Cholestasis		during pregnancy
Secondary	Viral load in infant		at birth, 2 months, and 18 months
Secondary	HCV antibody status in infant	positive or negative	at 18 months of age
Secondary	Birth weight of infant		at birth
Secondary	Hyperbilirubinemia	Peak total bilirubin of at least 15 mg% or the use of phototherapy	at birth
Secondary	Neonatal intensive care unit (NICU) admission		at birth
Secondary	Small for gestational age	Defined as less than the 5th percentile birth weight for gestational age at birth, assessed specifically by sex and race of the infant based on United States birth certificate data	at birth
Secondary	Neonatal infections	sepsis and pneumonia	at birth