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.
Study Type
OBSERVATIONAL
Enrollment
74
Klinik für Geburtsmedizin, Universitätsklinikum Jena
Jena, Thuringia, Germany
RECRUITINGbile acid profile
Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood)
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
TGR-5 activity
TGR5 activation by immunosuppressive bile acids calculated according to published protocols (Leonhardt et al. 2021)
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
bile acid profile in stool
The bile acid profile in stool is an exploratory outcome measure that examines the composition and concentration of various bile acids in stool samples.
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
materno-fetal bile acid transfer rate (bile acid profile)
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).
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
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