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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05929963
Enrollment
300
Registered
2023-07-05
Start date
2023-05-09
Completion date
2025-01-01
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepacivirus, Pregnancy

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.

Interventions

OTHERHCV infection status

Divided into 3 groups based on HCVAb and HCVRNA status

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of various adverse pregnancy outcomes2023-2025The 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

MeasureTime frameDescription
Mother-to-child transmission rate of HCV2023-2025Mother-to-child transmission rate of HCV in pregnant women and correlation with HCV RNA viral load
Development of children born to HCV pregnant women2023-2025We 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026