Liver Affection in Pregnant Women at Sohag University Hospital (LAIPWASUH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Biomarkers

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 Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

All pregnant women >18 years old with elevated Liver enzyme levels All pregnant women >18 years old with elevated bilirubin level

Exclusion Criteria:

Pregnant women who refuse to participate in the study, Pregnant women with biliary diseases (e.g., cholangitis, cholecystitis)

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline up to delivery

Collaborators and Investigators

• Sponsor: Eman Ashraf Saad Ahmed

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med--25-11-4MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No