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Long term efficacy and safety of antiviral therapy in the prevention of mother to child transmission of hepatitis B at stage of middle and late pregnancy

Long term efficacy and safety of antiviral therapy in the prevention of mother to child transmission of hepatitis B at stage of middle and late pregnancy

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17010869
Enrollment
Unknown
Registered
2017-03-14
Start date
2017-04-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

the prevention of mother to child transmission of hepatitis B

Interventions

Telbivudine group:oral administration
Tenofovir group :oral administration
Control group:No

Sponsors

Beijing Youan Hospital, CMU
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. CHB Pregnant woman HBsAg Postive =6 mouth HBV DNA=10E+6IU/ml; 2 Aged 18-45 years old; 3. Pregnancy women have all relevant documentation filing before12 weeks including HBsAg, HBsAb, HBeAg, HBeAb, HBcAb of hepatitis B, HBV-DNA, Genetype, HBV-DNA sequence, liver function, blood routine, liver B ultrasound et al; 4. The voluntary pregnancy received follow-up treatment antiviral nucleoside analogues and signed informed consent; 5. Pregnancy women agree to building obstetric filing pregnant childbirth in our hospital, and to follow-up according to the research project requirements in postpartum maternal; 6. According to the requirements of informed consent, Pregnancy women are able to make the corresponding testing, follow-up and intervention measures and have a good compliance.

Exclusion criteria

Exclusion criteria: 1. Combined infection with HCV, HIV, HDV, HEV, Treponema pallidum; 2. Diagnosis or suspected hepatocellular carcinoma or other malignant tumor; 3. Long term use of hormones or immunosuppressive agents; 4. Alcohol or drug addict; 5. Allergic history of nucleoside analogues; 6. Prenatal diagnosis of fetal congenital malformation; 7. Pregnant women with severe diseases of other organs affect follow-up compliance; 8. Those who need to take drugs after pregnancy or childbirth combined other disease; 9. Those who need to the long-term use of nucleoside analogues and the emergence of drug resistant before pregnancy.

Design outcomes

Primary

MeasureTime frame
serology index;Virological index;Biochemistry index;hormone;

Countries

China

Contacts

Public ContactZhang Hua

Beijing Youan Hospital, CMU

13717850635@163.com+86 13717850635

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 4, 2026