Prevalence of HBV in Pregnancy

NCT ID: NCT05442372

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-04-15

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.

Conditions

Hepatitis B

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• all pregnant women

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Amira Maher

Lecturer of Tropical Medicine and Gastroenterology, Faculty of Medicine, Sohag University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira Maher, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Sohag University

Locations

Sohag University Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Amira Maher, MD

Role: CONTACT

amiramaher@med.sohag.edu.eg

01006789652

Facility Contacts

Amira Maher, MD

Role: primary

amiramaher@med.edu.sohag.eg

00201006789652

Other Identifiers

Hepatitis B in pregnancy

Identifier Type: -

Identifier Source: org_study_id