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Prevalence of HBV in Pregnancy

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05442372
Collaborator
(none)
200
Enrollment
1
Location
6
Anticipated Duration (Months)
33.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Hepatitis B Virus Infection in Pregnancy
    Actual Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Nov 15, 2022
    Anticipated Study Completion Date :
    Dec 15, 2022

    Outcome Measures

    Primary Outcome Measures

    1. HBsAg [6 months]

      HBsAg prevalence in pregnancy

    2. Risk factors of HBV in pregnancy [6 months]

      Operations, blood transfusion, dental procedures, tattooing, family history of HBV

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all pregnant women
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Amira Maher, MD, Faculty of Medicine, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Maher, Lecturer of Tropical Medicine and Gastroenterology, Faculty of Medicine, Sohag University, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05442372
    Other Study ID Numbers:
    • Hepatitis B in pregnancy
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amira Maher, Lecturer of Tropical Medicine and Gastroenterology, Faculty of Medicine, Sohag University, Sohag University
    Hepatitis B
    Pregnancy
    Prevalence
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis

    Study Results

    No Results Posted as of Jul 19, 2022