NCT05442372

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

June 28, 2022

Last Update Submit

December 22, 2022

Conditions

Hepatitis B

Keywords

Hepatitis BPregnancyPrevalence

Outcome Measures

Primary Outcomes (2)

  • HBsAg

    HBsAg prevalence in pregnancy

    6 months

  • Risk factors of HBV in pregnancy

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

    6 months

Secondary Outcomes (1)

  • correlation between HBeAg and quantitative HBsAg with viral load

    6 months

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women attending antenatal care clinic

You may qualify if:

  • all pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Amira Maher, MD

    Faculty of Medicine, Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Maher, MD

CONTACT

01006789652amiramaher@med.sohag.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Gastroenterology, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 5, 2022

Study Start

June 15, 2022

Primary Completion

February 15, 2023

Study Completion

April 15, 2023

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

EG(1)