Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission

NCT03977987 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 233

Last updated 2019-06-12

No results posted yet for this study

Summary

The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.

Conditions

Interventions

DRUG

nucleos(t)ide analogue

Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Yonglan Pu · The First People's Hospital of Taicang

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03977987 on ClinicalTrials.gov