Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

Study Overview
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Brief Summary
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This study is a prospective study. The subject will select 440 cases of pregnant women with high hepatitis B virus load, and one group will take maternal and child blockade treatment with propofol fumarate. One group will take tenofovir disoproxil fumarate. Broken treatment, compare the failure rate of maternal and child blockade and the incidence of maternal and child adverse events in the two groups, and explore the efficacy and safety of propofol flavuril for the treatment of hepatitis B mother-infant block.

Detailed Description
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This study was a prospective cohort study. Because propofolofofovir is not covered by medical insurance and is more expensive, and there are factors such as renal function damage and the risk factors that can not use tenofovir, it is difficult to conduct randomized controlled cases. The subject will select 440 cases of pregnant women with high hepatitis B virus load. After signing the informed consent form, according to the patient's wishes, one group will take the mother-infant blockade of propofol fumarate, and one group will take fumaric acid. In the case of maternal and child blockade of benifovir, the incidence of maternal and child block failure and the incidence of maternal and child adverse events were compared between the two groups, and propofol fumarate was used for maternal and child blockade of hepatitis B. The effectiveness and safety of the treatment.

Official Title
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The Effect and Safety of Propofol Fumarate for Mother-to-child Blocking of Hepatitis B

Conditions
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Chronic Hepatitis B Infection, High Viral Load

Intervention / Treatment
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* Drug: TAF
* Drug: TDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No nucleoside analog antiviral drugs have been used in the past. HBsAg and HBeAg double positive, HBV DNA>106 IU/mL. Fully inform the risk to voluntarily join the study and sign the informed consent form. Exclusion Criteria: Combine other viral infections: such as HCV, HIV, CMV, etc.; amniocentesis during pregnancy; Liver cirrhosis and liver cancer; Other autoimmune diseases and liver diseases; fetal ultrasound screening in early and middle pregnancy found deformity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAF group<br>take propofol fumarate for Maternal and child blockade treatment | Drug: TAF<br>* Propofol tenofovir fumarate<br>|
| TDF group<br>take difenofurate fumarate for Maternal and child blockade treatment | Drug: TDF<br>* Dipirofurate fumarate tenofovir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the blocking successful rate of HBV mother-to-child transmission | HBV mother-to-child transmission blocking success rate (negative HBsAg and HBV DNA negative 7 months after birth) | 7 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of abnormal growth | The incidence of abnormal growth at birth | at birth, at the 7 months after birth | 
| The incidence of abnormal development | The incidence of abnormal development at birth | at birth, at the 7 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis B, Pregnant woman, High viral load, Tenofovir fumarate