Bile Acid Analysis for Intrahepatic Cholestasis in Pregnancy
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
Recruiting
Observational Study
Intrahepatic Cholestasis of Pregnancy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Study type
Observational
Participants needed
74 (estimated)
Sponsor
Jena University Hospital · Other
Who this trial is looking for
This trial is looking for pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition. Participants will provide blood and stool samples to help researchers learn more about bile acids and their effects on pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I am pregnant and have suspected ICP
I am pregnant and have confirmed ICP
I have elevated total bile acids
I have elevated liver enzymes
I experience itching with elevated liver enzymes
You may not be able to join if
I am under 18 years old
I am unable to provide informed consent
I have signs of an acute illness
I have known liver, biliary, or pancreatic diseases
I have a personal or family history of ICP
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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 causes bile acids to build up in the mother's bloodstream. This can lead to serious risks for the baby, including an increased chance of stillbirth, premature birth, and heart rhythm problems. Current monitoring methods (such as heart rate monitoring and ultrasound) often don't show warning signs before complications occur.
Participants will:
* Provide blood samples at each routine bile acid check during pregnancy and at delivery
* Provide stool samples for analyzing gut bacteria and bile acids
* Have their baby's umbilical cord blood collected at birth for bile acid analysis
* Undergo standard heart rate monitoring (CTG) of the baby
* Have ultrasound examination of the baby's heart (echocardiography) The study will compare three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. The researchers hope this information will help doctors better predict which pregnancies need more intensive monitoring and potentially prevent stillbirths and other complications in women with ICP.
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Eligibility Criteria
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 s…
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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