NCT07533929

Incidence and Predictors of Elevated ALT in Postpartum CHB Mothers

Incidence and Predictors of Elevated Alanine Aminotransferase in Postpartum Chronic Hepatitis B Mothers

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 352 (estimated)
• Sponsor: The Third Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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. It 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. To 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.

Conditions

• Elevated Alanine Aminotransferase
• Postpartum Chronic Hepatitis B Mothers

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-04-16
• Last updated: 2026-04-16