The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an

April 23, 2025 updated by: He Yingli, First Affiliated Hospital Xi'an Jiaotong University

The Epidemic Status and Development Trend of Hepatitis C Virus Infection in Pregnant Women in Xi'an: A 10-Year Retrospective Study

The objectives of this study are to improve HCV linkage-to-care in Chinese women and provide theoretical basis for the scientific formulation of HCV prevention and control strategies for pregnant women.

To understand the epidemiological changes and status of hepatitis C virus (HCV) infection in pregnant women in Shaanxi province in recent 10 years, and to analyze the main influencing factors of hepatitis C infection in pregnant women.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who had an antenatal visit or gave birth between 2014 and 2023.

Description

Inclusion Criteria:

  1. Pregnant women or parturient women confirmed by blood HCG test.
  2. Patients aged 18 years old and above.
  3. Patients with HCV antibody seropositive or HCV RNA positive from 2014-2023.

Exclusion Criteria:

  1. Patients without valid telephone numbers.
  2. Duplicate records: For duplicate records of the same pregnant woman, only one record should be kept.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women who had an antenatal visit or gave birth between 2014 and 2023.
Procedure: Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C
Initiated Standard DAA treatment among HCV RNA positive patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relink rate
Time Frame: From enrollment to the end of treatment at 12 weeks
The percentage of patients receiving DAA treatment among the diagnosed but untreated patients.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2024LSYY-413

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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