An Observational Study of Hepatitis C Virus in Pregnancy

NCT01959321 | Completed

• 18 other identifiers: HD36801-HCVU10HD036801UG1HD087230UG1HD027869UG1HD027915UG1HD034208UG1HD040500UG1HD040485UG1HD053097UG1HD040544UG1HD040545UG1HD040560UG1HD040512UG1HD068282UG1HD068258UG1HD068268UG1HD034116UG1HD087192
• Study Type: observational
• Target: 772
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Gestational age at delivery

  at birth

• Preterm delivery < 37 weeks of gestation

  at birth

• Gestational diabetes mellitus (GDM)

  during pregnancy

• Vaginal bleeding during pregnancy

  during pregnancy

• Preeclampsia

  during pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Singleton pregnancy
• 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.
• 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.

You may not qualify if:

• Planned termination of pregnancy
• Known major fetal anomalies or demise
• 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.
• Participation in this study in a previous pregnancy.
• Unwilling or unable to commit to 18 months of follow-up for HCV positive infants

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (17)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Stanford, California, 94305-5317, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Boston Medical Center

Boston, Massachusetts, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235-9032, United States

Location

University of Texas - Galveston

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• Grasch JL, de Voest JA, Saade GR, Hughes BL, Reddy UM, Costantine MM, Chien EK, Tita ATN, Thorp JM Jr, Metz TD, Wapner RJ, Sabharwal V, Simhan HN, Swamy GK, Heyborne KD, Sibai BM, Grobman WA, El-Sayed YY, Casey BM, Parry S; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Breastfeeding Initiation, Duration, and Associated Factors Among People With Hepatitis C Virus Infection. Obstet Gynecol. 2024 Mar 1;143(3):449-455. doi: 10.1097/AOG.0000000000005499. Epub 2024 Jan 4.

  PMID: 38176013 DERIVED

• 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.

  PMID: 32168224 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

maternal serum maternal plasma infant serum infant plasma cord blood plasma cord blood buffy coat

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Monica Longo, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

• Rebecca Clifton, PhD

  The George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Mona Prasad, DO, MPH

  Ohio State University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2012
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (17)