chronic HBV infection
Conditions
Interventions
Second and third trimester treatment group:Oral TDF in the second and third trimester
Conventional block group:No intervention
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) serum HBsAg, HBeAg double positive; (2) HBV DNA = 1 × 10^6 IU / ml; (3) Aged 20-40 years old; (4) Guaranteed perinatal examination and childbirth in the subject research unit; (5) Complete information from 8 weeks of pregnancy; (6) Compliance, and appropriate interventions; (7) Understand research and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Serum alanylaminotransferase (ALT) = 10 ULN (upper limit); (2) Serum total bilirubin (TBIL) = 34.2 umol/L; (3) serum albumin (ALB) = 25g/L; (4) serum creatinine (Cr) = upper limit of normal value or creatinine clearance rate (CCr) <100 or blood phosphorus (P) is lower than normal; (5) Infection with any of HCV, HIV, EBV, CMV, HEV, Treponema pallidum, herpes virus, rubella virus, Toxoplasma, etc.; (6) There are more serious liver diseases such as cirrhosis, or thyroid disease, diabetes, severe kidney disease, cardiovascular and cerebrovascular diseases, or immunocompromised diseases (including malignant tumors); (7) Family history of congenital diseases or immune genetic defects or Down's screening abnormalities; (8) Any obstetric ultrasound examination before 12 weeks of pregnancy suspects or suggests fetal malformation and/or dysplasia; (9) Renal dysfunction occurred during the previous antiviral treatment with adefovir or tenofovir; (10) Anti-hepatitis B virus treatment in the first half of pregnancy; (11) used long-term (medication for more than 4 weeks) application of immunomodulators; (12) Passive immunity has still occurred in the previous delivery of infants; (13) The father of the baby is HBsAg positive (chronic HBV infection); (14) Currently participating in other clinical trial studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of mother-to-child transmission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Congenital malformation rate of infants;Characteristics of hepatitis episodes after drug withdrawal;Maternal and child safety; | — |
Countries
China
Contacts
Public ContactDuan Zhongping
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed