Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With CHB Infection

Study Overview
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Brief Summary
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To date, several studies have manifested that high levels of adrenal corticosteroids and oestrogen hormones during pregnancy can lead to increased HBV viraemia. These hormonal and immune function status changes can result in minimal fluctuations in liver function tests. Serum alanine aminotransferase (ALT) tends to increase in late pregnancy and the postpartum period. Peripartum hepatitis flares leading to hepatic decompensation have been reported.Therefore, the investigators aim to detect and observe the immune function status and incidence of hepatitis in pregnant women with chronic hepatitis B virus infection in late pregnancy and the postpartum period.To provide a clinical evidence for the administration of chronic hepatitis B virus infection pregnant women.

Detailed Description
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In this trial, pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A, In addition ,the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group).In which, all pregnants were chronic HBV infection without compensated cirrhosis,hepatic adipose infiltration,ICP, hypertension ,heart disease, postpartum hemorrhage. None of the mothers were co-infected with hepatitis A,C,D,E,or HIV;syphilis, Epstein-Barr virus.Serum HBV DNA load(Roche, Pleasanton, CA, USA), HBsAg/anti-HBs level, HBeAg/anti-HBe routine blood test, liver function, renal function will be tested piror to delivery and postpartum 2,6,12 weeks. plasmacytoid dendritic cells(pDCs) and natural killer(NK)cells,CD4＋T cells and regulatory T (Treg) cells were detected by flow cytometry. Plasma cytokines Interferon-alpha 2(IFN-α2) / Interferon-gamma (IFN-γ) / Transforming growth factor beta1 (TGF-β1) / Interleukin-2 (IL-2) / Interleukin-6 (IL-6)/Interleukin-10(IL-10) / Interleukin-17A (IL-17A) / tumor necrosis factor-α1(TNF-α1)were measured by Luminex at the above time point except 2 weeks.

Official Title
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Immune Function Status and the Prevalence of Hepatitis in Postpartum Pregnant Women With Chronic Hepatitis B Virus Infection

Conditions
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Chronic Hepatitis B

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL/undetectable HBVDNA ,alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy Exclusion Criteria: compensated cirrhosis,hepatic adipose infiltration,ICP. hypertension ,heart disease. postpartum hemorrhage. pregnants who were co-infected with hepatitis A,C,D,E,or HIV;syphilis,Epstein-Barr virus.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| group A<br>pregnants who were positivity for serum HBsAg for more than 6 months and HBeAg , HBV DNA >106IU/mL, alanine aminotransferase (ALT) below 35 IU/mL (ULN=40IU/mL) and no received nucleoside analogue antiviral therapy were enrolled into group A | |
| group B<br>the CHB infection pregnants with undetectable HBVDNA were enrolled into group B(control group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of pDCs/ NK/CD4＋T/ Treg cells | the immune function of CHB infecion pregnant women will be evaluated by pDCs/ NK/CD4＋T/ Treg cells | in late pregnancy and postpartum 6,12weeks | 
| the change of IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1 | the immune function of CHB infecion pregnant women will be evaluated by IFN-α2 / IFN-γ)/ TGF-β1 /IL-2 / IL-6/ IL-10 / IL-17A / TNF-α1 | in late pregnancy and postpartum 6,12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of HBVDNA levels (IU/ML) | the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis B virus infection will be evaluated by HBV markers and HBV DNA levels and liver function | in late pregnancy and postpartum 2,6,12weeks | 
| the change of ALT levels(U/L) | the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis B virus infection will be evaluated by HBV markers and HBV DNA levels and liver function | in late pregnancy and postpartum 2,6,12weeks | 
| the change of AST levels(U/L) | the prevalence of hepatitis in postpartum pregnant women with chronic hepatitis | in late pregnancy and postpartum 2,6,12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis B, pregnancy, Cellular immune response, Clinical implications