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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAF group | take propofol fumarate for Maternal and child blockade treatment |
| |
| TDF group | take difenofurate fumarate for Maternal and child blockade treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAF | Drug | Propofol tenofovir fumarate |
| |
| TDF |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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High HBV viral load (HBV DNA ≥ 106 IU / mL) pregnant women with chronic HBV infection. All pregnant women with chronic HBV infection were in compliance with the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Yi, Doctor | Contact | 13683687062 | yiwei1215@163.com | |
| Yao Xie, Doctor | Contact | 13501093293 | xieyao00120184@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Yi, Doctor | Beijing Ditan Hospital | Principal Investigator |
| Yao Xie, Doctor | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Drug |
Dipirofurate fumarate tenofovir |
|
| at birth, at the 7 months after birth |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |