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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test

NCT01312012

Hepatitis B Virus Infection, Pregnancy

UNKNOWN PHASE4

A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk

NCT02901418

Chronic Hepatitis B

UNKNOWN

Clinical Study on the Effect of IVF-ET on Mother-to-child Transmission of Hepatitis B Virus

NCT03932851

Pregnancy

UNKNOWN

Mother-to-child Transmission of HBV in China

NCT05172453

Hepatitis B, Chronic Mother to Child Transmission

RECRUITING

Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin

NCT00000580

Hepatitis B Hepatitis, Viral, Human Liver Diseases

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The treatment group

Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who agree to receive the antiviral treatment during the late pregnancy.

nucleos(t)ide analogue

Intervention Type 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.

The control group with high HBV DNA level

Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who decline to receive the antiviral treatment during the late pregnancy.

No interventions assigned to this group

The control group with low HBV DNA level

Pregnant women with high HBV DNA level \< 2\*10\^6 IU/ml

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No