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NCT Number: NCT07300345

Liver Affection in Pregnant Women at Sohag University Hospital

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.

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Key information

Conditions

Liver Biomarkers

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eman Ashraf Saad Ahmed

Other

Registry information

Official study title

Liver Affection in Pregnant Women at Sohag University Hospitals

Acronym: LAIPWASUH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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