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Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

Recruitingn/aAges 18 Years - 45 YearsFemaleJena University Hospital
NCT07428226 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the baby. The main questions it aims to answer are: * Can measuring specific types of bile acids (particularly taurine-conjugated versus glycine-conjugated bile acids) in the mother's and baby's blood help predict the risk of stillbirth and other complications? * Do these bile acid patterns activate specific receptors (TGR5) that might contribute to immune problems or heart rhythm abnormalities in the baby? * How do bile acid patterns in the mother's stool relate to her gut bacteria and the severity of ICP? * Can heart rate monitoring (CTG) combined with bile acid measurements better identify high-risk pregnancies? ICP is a pregnancy-related liver condition that caus

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📋 Eligibility rules (as published)
Inclusion Criteria Group I: * Minimum age of 18 years * Written informed consent * Pregnant patients with suspected ICP * Pregnant patients with confirmed ICP * Pregnant patients with elevated total bile acids (\>14 µmol/ml) * Pregnant patients with elevated liver enzymes * Pregnant patients that suffer from itching with elevated transaminases Inclusion Criteria Group II: * Minimum age of 18 years * Confirmed pregnancy * Written informed consent * Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification) Inclusion Criteria Group III: * Minimum age of 18 years * Female gender * Pregnancy excluded * Written informed consent * Generally considered healthy in common usage (corresponding to ASA II of the American Society of Anesthesiologists classification) Exclusion Criteria Group II and III: * Age \<18 years * Inability to provide informed consent * Signs of an acute illness (for control groups II and III) * Known liver, biliary, or pancreatic diseases (for control groups II and III) * ICP in personal or family medical history (for control groups II and III)
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What it tests

  • Not listed
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Where

1 site
Klinik für Geburtsmedizin, Universitätsklinikum Jena
Jena, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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