Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy
1 other identifier
observational
300
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2023
CompletedStudy Start
First participant enrolled
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 5, 2023
June 1, 2023
10 months
May 8, 2023
June 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of various adverse pregnancy outcomes
The probability of postpartum haemorrhage, gestational diabetes mellitus and gestational hypertension in pregnant women infected with hepatitis C virus and the associated factors affecting them
2023-2025
Secondary Outcomes (2)
Mother-to-child transmission rate of HCV
2023-2025
Development of children born to HCV pregnant women
2023-2025
Study Arms (3)
HCV Ab(+）HCVRNA（-）
HCV Ab（+） HCVRNA(-) in pregnant women
HCV Ab(+）HCVRNA（+）
HCV Ab(+）HCVRNA（+）in pregnant women
HCVAb(-) HCVRNA(-)
HCV Ab(-）HCVRNA（-）in pregnant women
Interventions
Divided into 3 groups based on HCVAb and HCVRNA status
Eligibility Criteria
Pregnant women with hepatitis C:RNA negative (anti-HCV positive and HCV RNA negative) or RNA positive (anti-HCV positive and HCV RNA positive) pregnant women
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Ditan Hospital
Beijing, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yao Xie, Doctor
Beijing Ditan Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
May 8, 2023
First Posted
July 5, 2023
Study Start
May 9, 2023
Primary Completion
February 20, 2024
Study Completion
January 1, 2025
Last Updated
July 5, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share