Hepatitis BNCT05442372
Prevalence of HBV in Pregnancy
An observational study of Hepatitis B, run by Sohag University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Hepatitis B
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: pregnant women attending antenatal care clinic
Who may be able to join
- all pregnant women
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Amira Maher, MD, 00201006789652, amiramaher@med.edu.sohag.eg
About this study
Official title: Prevalence of Hepatitis B Virus Infection in Pregnancy
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.
Read the 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
- Keywords
- Hepatitis B, Pregnancy, Prevalence
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg
HBsAg prevalence in pregnancy
Measured: 6 months
Risk factors of HBV in pregnancy
Operations, blood transfusion, dental procedures, tattooing, family history of HBV
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Jun 2022
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Maher, Sohag University
- Investigators
- Amira Maher, MD, Principal investigator, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442372
- Sponsor's protocol ID
- Hepatitis B in pregnancy
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis B Virus Infection in Pregnancy
- ClinicalTrials.gov ID
- NCT05442372
- Acronym / sponsor ID
- Hepatitis B in pregnancy
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Pregnancy, Prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pregnant women attending antenatal care clinic
Key inclusion criteria (1 listed)
- all pregnant women
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBsAg
Time frame: 6 months
HBsAg prevalence in pregnancy
Risk factors of HBV in pregnancy
Time frame: 6 months
Operations, blood transfusion, dental procedures, tattooing, family history of HBV
1 secondary outcome
correlation between HBeAg and quantitative HBsAg with viral load
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Maher, MD principal investigator
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Maher, MD (01006789652, amiramaher@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.