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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05929963
• Other study ID #: DTXY28
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Hepacivirus
• Hepatitis C
• Pregnancy
• Pregnancy Complications, Infectious
• Virus Diseases

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