Prevalence of HBV in Pregnancy

Hepatitis B Clinical Trial

Official title:

Prevalence of Hepatitis B Virus Infection in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442372
• Other study ID #: Hepatitis B in pregnancy
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: December 2022
• Source: Sohag University
• Contact: Amira Maher, MD
• Phone: 01006789652
• Email: amiramaher[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• all pregnant women

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAg	HBsAg prevalence in pregnancy	6 months
Primary	Risk factors of HBV in pregnancy	Operations, blood transfusion, dental procedures, tattooing, family history of HBV	6 months
Secondary	correlation between HBeAg and quantitative HBsAg with viral load	to evaluate the predictive value of HBeAg and quantitative HBsAGg as surogate markers for high viraemia in pregnant women hbe ag	6 months