Prevalence of HBV in Pregnancy

Recruiting

• Conditions: Hepatitis B

• Registration Number: NCT05442372
• Lead Sponsor: Sohag University

Brief Summary

The most common mode of HBV transmission is materno-fetal transmission mainly during labor. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Detailed Description

Hepatitis B virus (HBV) is a cause of a vaccine-preventable life-threatening infection of the liver. Worldwide, the estimated number of cases of chronic HBV infection is 296 million cases with about 820 000 deaths, mostly due to liver cirrhosis and hepatocellular carcinoma. The prevalence of HBV infection among pregnant women is estimated to be 1.5-9.5%. The most important risk factor of materno-fetal transmission is high viremia. Other factors include hepatitis B e antigen (HBeAg) seropositivity, HBV S variant, and threatened preterm labor. Quantitative hepatitis B surface antigen (HBsAg) was postulated as a surrogate marker for HBV high viremia in pregnant women by many authors. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23
• Primary Completion: 2023-02-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• all pregnant women

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HBsAg	6 months	HBsAg prevalence in pregnancy
Risk factors of HBV in pregnancy	6 months	Operations, blood transfusion, dental procedures, tattooing, family history of HBV

Secondary Outcome Measures

Name	Time	Method
correlation between HBeAg and quantitative HBsAg with viral load	6 months	to evaluate the predictive value of HBeAg and quantitative HBsAGg as surogate markers for high viraemia in pregnant women hbe ag

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt