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

NCT06952036 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2024LSYY-413
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HCV Infection; HCV Elimination

Keywords

Hepatitis C; HCV elimination; Women of childbearing age

Outcome Measures

Primary Outcomes (1)

• Relink rate

  The percentage of patients receiving DAA treatment among the diagnosed but untreated patients.

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

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

Interventions

Standard Direct-acting antivirals (DAA) treatment procedures for patients with hepatitis C PROCEDURE

Initiated Standard DAA treatment among HCV RNA positive patients.

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

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

Central Study Contacts

Yingli He

CONTACT

+86-18991232863; heyingli2000@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Infectious Diseases, the First Affiliated Hospital of Jiaotong University

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: April 25, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04