Skip to content

The Pathogenesis of Hepatitis C Virus Vertical Transmission

The Pathogenesis of Hepatitis C Virus Vertical Transmission

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01921400
Enrollment
38
Registered
2013-08-13
Start date
2013-01-31
Completion date
2017-12-31
Last updated
2018-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Infection Transmission, Maternal-Fetal

Keywords

Hepatitis C (HCV), Infection Transmission, Maternal-Fetal, Placenta, Trophoblast

Brief summary

To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively. In parallel, we will assess placental tissue for evidence of HCV infection using a novel in situ hybridization technique and translate our in vitro findings to these in vivo samples. Our overall hypothesis is that cytotrophoblasts at the maternal-fetal interface within the placenta serve as a barrier that must be crossed during vertical transmission and that cytotrophoblasts are permissive to HCV at a low level that may be enhanced under certain conditions. By comparing the regulation of key steps in the intracellular life cycle of HCV in cytotrophoblasts to highly permissive hepatocytes, significant differences in HCV regulation should be revealed. Based on our preliminary data, our working hypothesis is that HCV Core protein is differentially processed in cytotrophoblasts compared to hepatocytes.

Interventions

None listed

Sponsors

University of Maryland
CollaboratorOTHER
Cairo University
CollaboratorOTHER
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women with HCV infection * Pregnant women without HCV infection

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
To evaluate for the presence of HCV Core protein, HCV RNA and SPP in the placenta and fetal membranes using paraffin-embedded sections and post-delivery specimens respectively.1 yearWe will begin by examining paraffin-embedded sections from HCV-infected mothers who had the placentas sent to pathology for analysis.We will perform a combination of immunohistochemistry (IHC) and immunofluorescence (IF) to analyze the level of SPP expression in the trophoblast cell layer, as well as if HCV Core protein expression was detectable in this layer or in any cell type within the placental section. We would also plan to identify other patient-derived tissues that were not paraffin embedded, both from uninfected patients and infected patients to validate different parts of our preliminary data. We would plan to use dissected fetal membranes, which contain both chorion and amnion, to investigate the level of SPP expression in these tissues.

Countries

Egypt, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026