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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Hepacivirus
• Intervention / Treatment: Other: HCV infection status

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Ditan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCV Ab(+）HCVRNA（-）; HCV Ab（+） HCVRNA(-) in pregnant women	Other: HCV infection status; Divided into 3 groups based on HCVAb and HCVRNA status
HCV Ab(+）HCVRNA（+）; HCV Ab(+）HCVRNA（+）in pregnant women	Other: HCV infection status; Divided into 3 groups based on HCVAb and HCVRNA status
HCVAb(-) HCVRNA(-); HCV Ab(-）HCVRNA（-）in pregnant women	Other: HCV infection status; Divided into 3 groups based on HCVAb and HCVRNA status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Ditan Hospital
• Investigators: Principal Investigator: Yao Xie, Doctor, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): February 20, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Pregnancy Complications; Hepatitis; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hepatitis C; Virus Diseases; Pregnancy Complications, Infectious
• Other Study ID Numbers: DTXY28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No