The effect on the delevopment of infants in mothers with hepatitis B who received tenofovir-DF treatment during the second or third pregnancy

The effect on the delevopment of infants in mothers who received tenofovir-DF for preventing mother to child transimission of hepatitis B virus during the second or third pregnancy

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900025111

Enrollment

Unknown

Registered

2019-08-11

Start date

2019-08-01

Completion date

Unknown

Last updated

2019-08-27

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

Conditions

vertical transmission of hepatitis B virus

Interventions

observational group:Tenofovir will be administered orally from 24 to 28 weeks of gestation. The newborns will be given hepatitis B vaccine 10 ug, 0-1-6 months, and hepatitis B immunoglobulin 100 IU at

control:Antiviral drugs will not be taken during pregnancy. The newborns will be given hepatitis B vaccine 10 ug, 0-1-6 months, and hepatitis B immunoglobulin 100 IU at birth.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants of mothers with HBsAg positive >= 6months (observation group: HBsAg positive infants with HBV-DNA>1*10E+6IU/ml, infants born to mothers who received tenofovir antiviral therapy at 24-28 weeks gestation to block mother-to-child transmission.Control group: infants delivered by HBsAg positive mothers with HBV-DNA<1*10E+6IU/ml during the same period, who did not need to take antiviral drugs during pregnancy.)Before delivery, the mother had consecutive HBV-markers, HBV-DNA, genotype, HBV-DNA Sequence,Liver Function, Blood Routine, B-ultrasonography of liver, with complete relevant information. The pregnancy examination and delivery would be conducted in the department of obstetrics in our hospital. After delivery, the mothers and infants could continue to follow up as required by advised program, and the informed consent was signed. The compliance was good.

Exclusion criteria

Exclusion criteria: Mothers co-infection with hepatitis C, D, E, HIV or TP; concurrent treatment with immune modulators,cytotoxic drugs, or steroids; allergy to NAs; evidence of foetal deformity before delivery; initiating TDF treatment brfore conception.

Design outcomes

Primary

Measure	Time frame
Infant bone density;	—

Secondary

Measure	Time frame
Gross growth developmental;Intellectual development;adverse events of infant;congenital defect;	—

Countries

China

Contacts

Public ContactMing Wang

Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University

18763431543@163.com+86 18810438127

Outcome results

None listed

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