Liver BiomarkersLAIPWASUHNCT07300345
Liver Affection in Pregnant Women at Sohag University Hospital
An observational study of Liver Biomarkers, run by Eman Ashraf Saad Ahmed.
Trial summary
This study investigates the prevalence, causes, and clinical outcomes of liver disorders among pregnant women attending Sohag University Hospital. It aims to identify the most common hepatic conditions occurring during pregnancy, evaluate their impact on maternal and fetal health, and assess the effectiveness of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Liver Biomarkers
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population includes pregnant women attending Sohag University Hospital during the study period. Participants are women of reproductive age with a confirmed pregnancy who are diagnosed with the targeted liver disorder. Inclusion is irrespective of gestational age at diagnosis, while women with pre-existing chronic liver failure or other severe systemic illnesses are excluded. The study focuses exclusively on female participants
Who may be able to join
- All pregnant women >18 years old with elevated Liver enzyme levels All pregnant women >18 years old with elevated bilirubin level
Who cannot join
- Pregnant women who refuse to participate in the study, Pregnant women with biliary diseases (e.g., cholangitis, cholecystitis)
- -
About this study
Official title: Liver Affection in Pregnant Women at Sohag University Hospitals
This study investigates the prevalence, causes, and clinical outcomes of liver disorders among pregnant women attending Sohag University Hospital. It aims to identify the most common hepatic conditions occurring during pregnancy, evaluate their impact on maternal and fetal health, and assess the effectiveness of current diagnostic and management approaches. By analyzing clinical data, laboratory findings, and pregnancy outcomes, the study highlights the importance of early detection and proper management of liver diseases to reduce associated complications and improve overall maternal-fetal prognosis.
Read the detailed description
This study provides evaluation of liver disorders among pregnant women attending Sohag University Hospital. The research aims to determine the prevalence of hepatic conditions during pregnancy, classify the most common liver diseases encountered, and analyze their etiologies, clinical presentations, and laboratory characteristics. Special emphasis is placed on conditions unique to pregnancy-such as intrahepatic cholestasis of pregnancy, HELLP syndrome, and acute fatty liver of pregnancy-as well as pre-existing or coincidental liver diseases, including viral hepatitis and autoimmune hepatic disorders.
The study further examines the impact of these hepatic conditions on both maternal and fetal outcomes. . By reviewing diagnostic tools, biochemical markers, and imaging findings, the research evaluates the effectiveness of current diagnostic pathways used in the hospital setting.
- Conditions
- Liver Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all pregnant women attending sohag university hospitals for liver disease assessment | Participants in this group will undergo a single assessment during their hospital visit. This includes history taking, brief medical history, and collecting routine laboratory and imaging results. No additional procedures or intervention will be performed specifically for this study. The purpose is estimate prevalence of liver diseases in pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver disease severity index
Change from baseline in a standardized liver disease severity index combining biochemical and clinical measures in pregnant women. The index is computed using: serum ALT (IU/L), AST (IU/L), total bilirubin (mg/dL), albumin (g/dL), INR, and a short clinical symptom score (pruritus, jaundice, abdominal pain). Outcomes reported as absolute change and percent change in the composite score to evaluate progression or improvement of the liver disorder.
Measured: from baseline up to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver BiomarkersStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Ashraf Saad Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Ashraf Saad Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300345
- Sponsor's protocol ID
- Soh-Med--25-11-4MS
- Acronym
- LAIPWASUH
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Affection in Pregnant Women at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT07300345
- Acronym / sponsor ID
- LAIPWASUH / Soh-Med--25-11-4MS
- Conditions
- Liver Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eman Ashraf Saad AhmedUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (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.
This study investigates the prevalence, causes, and clinical outcomes of liver disorders among pregnant women attending Sohag University Hospital. It aims to identify the most common hepatic conditions occurring during pregnancy, evaluate their impact on maternal and fetal health, and assess the effectiveness of current diagnostic and management approaches. By analyzing clinical data, laboratory findings, and pregnancy outcomes, the study highlights the importance of early detection and proper management of liver diseases to reduce associated complications and improve overall maternal-fetal prognosis.
Detailed description
This study provides evaluation of liver disorders among pregnant women attending Sohag University Hospital. The research aims to determine the prevalence of hepatic conditions during pregnancy, classify the most common liver diseases encountered, and analyze their etiologies, clinical presentations, and laboratory characteristics. Special emphasis is placed on conditions unique to pregnancy-such as intrahepatic cholestasis of pregnancy, HELLP syndrome, and acute fatty liver of pregnancy-as well as pre-existing or coincidental liver diseases, including viral hepatitis and autoimmune hepatic disorders.
The study further examines the impact of these hepatic conditions on both maternal and fetal outcomes. . By reviewing diagnostic tools, biochemical markers, and imaging findings, the research evaluates the effectiveness of current diagnostic pathways used in the hospital setting.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all pregnant women attending sohag university hospitals for liver disease assessment | – | –Participants in this group will undergo a single assessment during their hospital visit. This includes history taking, brief medical history, and collecting routine laboratory and imaging results. No additional procedures or intervention will be performed specifically for this study. The purpose is estimate prevalence of liver diseases in pregnant women |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes pregnant women attending Sohag University Hospital during the study period. Participants are women of reproductive age with a confirmed pregnancy who are diagnosed with the targeted liver disorder. Inclusion is irrespective of gestational age at diagnosis, while women with pre-existing chronic liver failure or other severe systemic illnesses are excluded. The study focuses exclusively on female participants
Key inclusion criteria (1 listed)
- All pregnant women >18 years old with elevated Liver enzyme levels All pregnant women >18 years old with elevated bilirubin level
Key exclusion criteria (2 listed)
- Pregnant women who refuse to participate in the study, Pregnant women with biliary diseases (e.g., cholangitis, cholecystitis)
- -
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
Change in liver disease severity index
Time frame: from baseline up to delivery
Change from baseline in a standardized liver disease severity index combining biochemical and clinical measures in pregnant women. The index is computed using: serum ALT (IU/L), AST (IU/L), total bilirubin (mg/dL), albumin (g/dL), INR, and a short clinical symptom score (pruritus, jaundice, abdominal pain). Outcomes reported as absolute change and percent change in the composite score to evaluate progression or improvement of the liver disorder.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Biomarkers, run by Eman Ashraf Saad Ahmed.
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 2 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: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver disease severity index (time frame: from baseline up to delivery). 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 2025.