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

• Conditions: Hepacivirus; Pregnancy
• Interventions: Other: HCV infection status

• Registration Number: NCT05929963
• Lead Sponsor: Beijing Ditan Hospital

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-08
• Study Start: 2023-05-09
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-24
• Last Update Submitted: 2023-06-24
• Study First Posted: 2023-07-05
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-02-20
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV Ab(+）HCVRNA（-）	HCV infection status	HCV Ab（+） HCVRNA(-) in pregnant women
HCVAb(-) HCVRNA(-)	HCV infection status	HCV Ab(-）HCVRNA（-）in pregnant women
HCV Ab(+）HCVRNA（+）	HCV infection status	HCV Ab(+）HCVRNA（+）in pregnant women

Primary Outcome Measures

Name	Time	Method
Incidence of various adverse pregnancy outcomes	2023-2025	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

Secondary Outcome Measures

Name	Time	Method
Development of children born to HCV pregnant women	2023-2025	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）.
Mother-to-child transmission rate of HCV	2023-2025	Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load

Trial Locations

Locations (1)

Beijing Ditan Hospital; 🇨🇳 Beijing, China