Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Antiviral Agents; Tenofovir

Criteria

Inclusion criteria:

• Women aged 20-45 years in 28 to 32 weeks of pregnancy

• Positive HBsAg and HBeAg

• Serum viral load above 6 log10 IU/mL

Exclusion criteria:

• Major systemic disease of the mother or fetus

• Positive anti-HIV or anti-HCV

• Under treatment of antiviral therapy

• Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus

• Pregnant woman whose amniocentesis reveals any genetic abnormality