Actively Recruiting
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
Led by Jena University Hospital · Updated on 2026-02-23
74
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 b5mol/ml)
- Pregnant patients with elevated liver enzymes
- Pregnant patients that suffer from itching with elevated transaminases
- Minimum age of 18 years
- Confirmed pregnancy
- Generally considered healthy (ASA II classification)
- Minimum age of 18 years
- Female gender
- Pregnancy excluded
- Generally considered healthy (ASA II classification)
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Klinik für Geburtsmedizin, Universitätsklinikum Jena
Jena, Thuringia, Germany, 07747
Actively Recruiting
Research Team
S
Silke Große, Dr. rer. nat.
CONTACT
J
Janine Zöllkau, Dr. med.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here