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

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Capital Medical University

Status

Invitation-only

Conditions

Hepacivirus
Pregnancy

Treatments

Other: HCV infection status

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full description

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.

Enrollment

300 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

HCV Ab(+)HCVRNA(-)
Description:
HCV Ab(+) HCVRNA(-) in pregnant women
Treatment:
Other: HCV infection status
HCV Ab(+)HCVRNA(+)
Description:
HCV Ab(+)HCVRNA(+)in pregnant women
Treatment:
Other: HCV infection status
HCVAb(-) HCVRNA(-)
Description:
HCV Ab(-)HCVRNA(-)in pregnant women
Treatment:
Other: HCV infection status

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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