Chronic viral hepatitis B
Conditions
Interventions
HBsAg(+) pregnant women group and healthy pregnant women group:No
healthy pregnant women group:No
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. HBsAg(+) group: 20-35 years; HBsAg positive for > 6 months; singleton; gestational age between 12-24 weeks; normal ALT on 2 consecutive measurements (at least >= 30 days apart); LSM = 30 days apart); singleton; LSM < 7.4 KPa and CAP < 259 dB/m. (largely matched to the HBsAg(+) group of pregnant mothers in terms of age, BMI and gestational age). 3. Patients in both groups must be able to understand and sign a written informed consent form, which must be obtained prior to the start of the study procedure.
Exclusion criteria
Exclusion criteria: 1. Co-infection with human immunodeficiency virus (HIV), hepatitis D virus (HDV), hepatitis C virus (HCV), syphilis, etc; 2. History of miscarriage or congenital malformation in previous pregnancies; 3. Treatment experience (unless antiviral drugs were used to prevent mother-to-child transmission in a previous pregnancy and discontinued more than 6 months before the current pregnancy); 4. History of renal insufficiency; evidence of hepatocellular carcinoma or decompensation; estimated creatinine clearance (CLCr) 2 mg/dL; 5. Clinical signs of preterm abortion; ultrasound evidence of fetal malformation; 6. Concomitant treatment with nephrotoxic drugs, steroids, cytotoxic drugs, NSAIDs or immunomodulators; recipients of solid organ or bone marrow transplants; renal, cardiovascular, pulmonary or neurological disease considered severe by the investigator; 7. Elevated ALT during the current pregnancy prior to admission; 8. Thyroid dysfunction; 9. Chronic liver disease other than hepatitis B; 10. previous pregnancy complications such as intrahepatic cholestasis of pregnancy (ICP), gestational hypertension, diabetes mellitus and proteinuria. Subjects who met any of the above exclusion criteria were not allowed to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alanine aminotransferase; | — |
Countries
China
Contacts
Public ContactShi Ouyang
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed