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NCT Number: NCT03977987

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The First People's Hospital of Taicang

Suzhou, Jiangsu, 215400, China

About this study

From 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis B infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. The investigators recommended those pregnant women with HBV DNA > 2*10^6 IU/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. Patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high HBV DNA level. Meanwhile, those pregnant women with HBV DNA < 2*10^6 IU/ml was assigned as the control group with low HBV DNA level. All infants would be instructed to receive hepatitis B vaccine and hepatitis B virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. Umbilical cord blood were collected to determine the HBV serological markers and HBV DNA level. Children were followed every three to four years until December 2018.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy

Exclusion criteria

  • women treated with antiviral drugs during pregnancy.
  • drug hypersensitivity;
  • abnormal renal laboratory results;
  • coinfection with human immunodeficiency virus or other human hepatitis viruses.

Treatment and study plan

Nucleos(t)ide analogue

Drug

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

Primary outcomes

  1. The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.

    Time frame: December, 2018

    We compare the proportion of children with chronic HBV born to mothers from three groups in the real life setting

Secondary outcomes

  1. the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the standardized immunoprophylaxis strategy

    Time frame: December, 2018

    We compare the proportion of children with chronic HBV born to mothers from three groups who followed the standardized immunoprophylaxis strategy

  2. the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the aggressive immunoprophylaxis strategy

    Time frame: December, 2018

    We compare the proportion of children with chronic HBV born to mothers from three groups who followed the aggressive immunoprophylaxis strategy

  3. The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood

    Time frame: At delivery

    We compare the proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood born to mothers from three groups

  4. The HBV DNA level of mothers among three groups

    Time frame: Within one week before delivery.

    We compare the HBV DNA level of mothers among three groups within one week before delivery.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Maternal Nucleos(t)Ide Analogue Use and Infants Immunoprophylaxis to Eliminate Hepatitis B Infection in the Real World Setting

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2019
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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