Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy

NCT ID: NCT05929963

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-01-01

Brief Summary

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The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question\[s\] it aims to answer are:

Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C

Detailed Description

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This study aims to collect demographic data, biochemical indicators during pregnancy, pregnancy complications, and fetal outcomes through the hospital HIS and LIS systems to investigate the impact of HCV infection on pregnancy outcomes, mother-to-child transmission, and long-term child development, and to provide assistance in the clinical management of pregnant women with HCV infection.

Conditions

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Hepacivirus Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCV Ab(+)HCVRNA(-)

HCV Ab(+) HCVRNA(-) in pregnant women

HCV infection status

Intervention Type OTHER

Divided into 3 groups based on HCVAb and HCVRNA status

HCV Ab(+)HCVRNA(+)

HCV Ab(+)HCVRNA(+)in pregnant women

HCV infection status

Intervention Type OTHER

Divided into 3 groups based on HCVAb and HCVRNA status

HCVAb(-) HCVRNA(-)

HCV Ab(-)HCVRNA(-)in pregnant women

HCV infection status

Intervention Type OTHER

Divided into 3 groups based on HCVAb and HCVRNA status

Interventions

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HCV infection status

Divided into 3 groups based on HCVAb and HCVRNA status

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* normal (anti-HCV negative) or RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
* pregnant women aged 20-45 years
* complete pregnancy data available

Exclusion Criteria

* Combination of other liver diseases such as viral hepatitis (hepatitis A, B, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease
* Combination of other viral infections with potential loss of liver function
* Mental illness
* Patients with immunosuppression
* Mother with cirrhosis or liver tumour
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yao Xie

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao Xie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

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Beijing Ditan Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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DTXY28

Identifier Type: -

Identifier Source: org_study_id

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