Clinical trial NCT03977987: Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission
Official title: Maternal Nucleos(t)Ide Analogue Use and Infants Immunoprophylaxis to Eliminate Hepatitis B Infection in the Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: hepatitis B
mother-to-children transmission
antiviral treatment
immunoprophylaxis
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 233
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the real-world setting, we recruited consecutively 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. Patients were excluded from participation if they had been treated with antiviral drugs during pregnancy. Additional exclusion criteria were drug hypersensitivity, abnormal renal laboratory results, coinfection with human immunodeficiency virus or other human hepatitis viruses.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.
timeFrame: December, 2018
Secondary outcomes:
measure: 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
timeFrame: December, 2018
measure: 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
timeFrame: December, 2018
measure: The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood
timeFrame: At delivery
measure: The HBV DNA level of mothers among three groups
timeFrame: Within one week before delivery.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First People's Hospital of Taicang
state: Jiangsu
Study officials:
affiliation: The First People's Hospital of Taicang
name: Yonglan Pu
role: STUDY_DIRECTOR
References: