Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Observational Study of Hepatitis C Virus in Pregnancy (HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959321
Recruitment Status : Active, not recruiting
First Posted : October 10, 2013
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Tracking Information
First Submitted Date October 8, 2013
First Posted Date October 10, 2013
Last Update Posted Date February 27, 2020
Study Start Date October 2012
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2017)
HCV infection of the offspring [ Time Frame: at 2 months and/or 18 months of age ]
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.
Original Primary Outcome Measures
 (submitted: October 8, 2013)
HCV infection of the offspring [ Time Frame: at 2 months and/or 18 months of age ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: October 8, 2013)
  • Gestational age at delivery [ Time Frame: at birth ]
  • Preterm delivery < 37 weeks of gestation [ Time Frame: at birth ]
  • Gestational diabetes mellitus (GDM) [ Time Frame: during pregnancy ]
  • Vaginal bleeding during pregnancy [ Time Frame: during pregnancy ]
  • Preeclampsia [ Time Frame: during pregnancy ]
  • Cholestasis [ Time Frame: during pregnancy ]
  • Viral load in infant [ Time Frame: at birth, 2 months, and 18 months ]
  • HCV antibody status in infant [ Time Frame: at 18 months of age ]
    positive or negative
  • Birth weight of infant [ Time Frame: at birth ]
  • Hyperbilirubinemia [ Time Frame: at birth ]
    Peak total bilirubin of at least 15 mg% or the use of phototherapy
  • Neonatal intensive care unit (NICU) admission [ Time Frame: at birth ]
  • Small for gestational age [ Time Frame: at birth ]
    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
  • Neonatal infections [ Time Frame: at birth ]
    sepsis and pneumonia
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Hepatitis C Virus in Pregnancy
Official Title An Observational Study of Hepatitis C Virus in Pregnancy
Brief Summary This multi-center observational study examines risk factors for HCV transmission from mother to baby.
Detailed 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
maternal serum maternal plasma infant serum infant plasma cord blood plasma cord blood buffy coat
Sampling Method Non-Probability Sample
Study Population Women with singleton pregnancies presenting for prenatal care prior to 23 weeks, 6 days gestation at Maternal-Fetal Medicine Units (MFMU) Network hospital sites.
Condition Hepatitis C
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Prasad M, Saade GR, Sandoval G, Hughes BL, Reddy UM, Mele L, Salazar A, Varner MW, Gyamfi-Bannerman C, Thorp JM Jr, Tita ATN, Swamy GK, Chien EK, Casey BM, Peaceman AM, El-Sayed YY, Iams JD, Gibbs RS, Sibai B, Wiese N, Kamili S, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Hepatitis C Virus Antibody Screening in a Cohort of Pregnant Women: Identifying Seroprevalence and Risk Factors. Obstet Gynecol. 2020 Apr;135(4):778-788. doi: 10.1097/AOG.0000000000003754.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 8, 2019)
772
Original Estimated Enrollment
 (submitted: October 8, 2013)
1800
Estimated Study Completion Date July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01959321
Other Study ID Numbers HD36801-HCV
U10HD036801 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD027869 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD068282 ( U.S. NIH Grant/Contract )
UG1HD068258 ( U.S. NIH Grant/Contract )
UG1HD068268 ( U.S. NIH Grant/Contract )
UG1HD034116 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.
Responsible Party The George Washington University Biostatistics Center
Study Sponsor The George Washington University Biostatistics Center
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Caroline Signore, M.D., MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center
Study Chair: Mona Prasad, DO, MPH Ohio State University
PRS Account The George Washington University Biostatistics Center
Verification Date February 2020