Intrahepatic Cholestasis of Pregnancy
Conditions
Keywords
Intrahepatic Cholestasis of pregnancy, Bile acid profile
Brief summary
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.
Interventions
None listed
Sponsors
Jena University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bile acid profile | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion | Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TGR-5 activity | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion | TGR5 activation by immunosuppressive bile acids calculated according to published protocols (Leonhardt et al. 2021) |
| bile acid profile in stool | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion | The bile acid profile in stool is an exploratory outcome measure that examines the composition and concentration of various bile acids in stool samples. |
| materno-fetal bile acid transfer rate (bile acid profile) | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion | The maternal-fetal bile acid transfer rate describes the extent and efficiency with which bile acids pass from the mother through the placenta into the fetal circulation (placental permeability). |
Countries
Germany
Contacts
CONTACTSilke Große, Dr. rer. nat.
CONTACTJanine Zöllkau, Dr. med.
STUDY_CHAIRTanja Groten, Prof. Dr. med.
University Hospital Jena
Outcome results
None listed