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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05929963
Other study ID # DTXY28
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 9, 2023
Est. completion date January 1, 2025

Study information

Verified date June 2023
Source Beijing Ditan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date January 1, 2025
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design


Intervention

Other:
HCV infection status
Divided into 3 groups based on HCVAb and HCVRNA status

Locations

Country Name City State
China Beijing Ditan Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mother-to-child transmission rate of HCV Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load 2023-2025
Secondary Development of children born to HCV pregnant women We will follow up on the child's weight (weight in kilograms), heigh(height in meters),Body mass index(BMI described in kg/m^2) ,head circumference(Head circumference described in metres),Head up, roll over, sit, crawl, stand and talk start time(Describe time in months). 2023-2025
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