[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633995":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":16,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":17,"locations":11,"responsibleParty":23,"collaborators":11,"id":25,"slug":11,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":11,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":11,"studyType":37,"phases":11,"briefSummary":38,"conditions":39,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":11},{"fullName":5,"class":6},"The Third Affiliated Hospital of Guangzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence of ALT elevation within 28 weeks postpartum in CHB pregnant women after 24 weeks of gestation in the antiviral treatment group and the non-antiviral treatment group",null,"2024-07-01 to 2029-12-31",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":14,"timePerspective":15,"maskingInfo":11},"COHORT","PROSPECTIVE","Postpartum condition of pregnant women with chronic hepatitis B",[18],{"name":19,"role":20,"phone":21,"phoneExt":11,"email":22},"Xingfei Pan","CONTACT","18127862160","panxf0125@163.com",{"type":24,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100633995",false,"NCT07533929","Incidence and Predictors of Elevated ALT in Postpartum CHB Mothers","Incidence and Predictors of Elevated Alanine Aminotransferase in Postpartum Chronic Hepatitis B Mothers","Inclusion Criteria:\n\nFemale; Between 20-40 years old; HBsAg positive for more than 6 months; ALT ≤40 U\u002FL; Any time point from 24 weeks of pregnancy to delivery; For HBV viral load \\>2x10\\^5 IU\u002Fml, regular TDF medication is required and should be stopped immediately after delivery; For HBV viral load \\\u003C2x10\\^5 IU\u002Fml, antiviral treatment is not needed; All patients should have good adherence.\n\nExclusion Criteria:\n\nAccompanied by hepatitis A, C, E viruses or other hepatotropic viral infections or AIDS; accompanied by cirrhosis, liver cancer, or other chronic liver diseases; accompanied by diseases of vital organs such as heart, lungs, or kidneys; accompanied by autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, thyroid diseases; previous pregnancy with complications; previous pregnancy with fetal or neonatal growth and developmental defects; previous or current use of nephrotoxic drugs, glucocorticoids, cytotoxic drugs, or immunomodulators; ultrasound before medication indicates fetal malformations, abnormal fetal development, placental abnormalities, or threatened miscarriage; use of anti-hepatitis B virus drugs within six months before pregnancy; failure to follow up regularly according to the study plan.","FEMALE","20 Years","40 Years",{"count":35,"type":36},352,"ESTIMATED","OBSERVATIONAL","China currently has about 86 million people with chronic hepatitis B virus infection, and infections caused by mother-to-child transmission account for 40% to 50% of new hepatitis B infections. Domestic and international guidelines both recommend that for pregnant women with high viral loads at 24-28 weeks of gestation, oral antiviral therapy should be administered based on a balance of risks and benefits and informed consent, continuing until after delivery, which can significantly reduce the rate of HBV mother-to-child transmission. Studies have reported that antiviral drugs such as tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) can reduce mother-to-child transmission rates in pregnant women with hepatitis B.\n\nIt has been reported that among pregnant women with hepatitis B infection and high viral loads but no obvious hepatitis, the incidence of postpartum hepatitis ranges from 15% to 35%. Among pregnant women who received antiviral therapy during pregnancy, 36.3% developed postpartum hepatitis. In a multicenter prospective randomized controlled trial (RCT), Pan and colleagues observed that the proportion of mothers with elevated ALT levels postpartum was 45% for those treated with tenofovir disoproxil fumarate (TDF) during pregnancy versus 30% for those untreated. A large retrospective cohort study involving 4,236 hepatitis B mothers in China found that the rate of postpartum ALT elevation in chronic hepatitis B pregnant women who did not receive antiviral therapy during pregnancy was 28.27%. This study also identified independent risk factors for postpartum ALT elevation, including high viral load during pregnancy. The peak periods of ALT elevation occurred between 4-6 weeks and 9-12 weeks postpartum, showing a bimodal distribution.\n\nTo explore the differences in prognosis between groups that did and did not receive antiviral therapy, we will conduct a prospective cohort study to assess the incidence of postpartum ALT elevation in mothers with chronic hepatitis B and identify independent risk factors that can predict postpartum ALT elevation. Our data will help healthcare providers better manage pregnant women with chronic hepatitis B.",[40,41],"Elevated Alanine Aminotransferase","Postpartum Chronic Hepatitis B Mothers","NOT_YET_RECRUITING","2026-04-09",{"date":45,"type":46},"2026-04-16","ACTUAL",{"date":48,"type":36},"2026-08-01",{"date":50,"type":36},"2029-12-31",{"name":5,"class":6}]