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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant ICP patients | Diagnosis or suspicion of an ICP according to Hagenbeck et al. 2021 | ||
| Healthy pregnant controls | Healthy patients with a confirmed pregnancy | ||
| Healthy non-pregnant controls | Healthy woman which are not pregnant |
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| Measure | Description | Time Frame |
|---|---|---|
| bile acid profile | Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood) | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| TGR-5 activity | TGR5 activation by immunosuppressive bile acids calculated according to published protocols (Leonhardt et al. 2021) | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion |
| bile acid profile in stool |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between bile acid profiles and TGR5 activation | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion |
Inclusion Criteria Group I:
Inclusion Criteria Group II:
Inclusion Criteria Group III:
Exclusion Criteria Group II and III:
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Group 1:
Participants in this group are pregnant women diagnosed with or suspected of having ICP who are being treated at the Clinic for Obstetrics, University Hospital Jena, as part of routine clinical care.
Group 2:
Participants in this group are healthy pregnant women without ICP who are receiving routine prenatal care at the Clinic for Obstetrics, University Hospital Jena.
Group 3:
Participants in this group are healthy, non-pregnant female volunteers participating in the study independently of the clinical care setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silke Große, Dr. rer. nat. | Contact | +493641 9-329293 | silke.grosse@med.uni-jena.de | |
| Janine Zöllkau, Dr. med. | Contact | janine.zoellkau@med.uni-jena.de |
| Name | Affiliation | Role |
|---|---|---|
| Tanja Groten, Prof. Dr. med. | University Hospital Jena | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Geburtsmedizin, Universitätsklinikum Jena | Recruiting | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34393256 | Background | Hagenbeck C, Hamza A, Kehl S, Maul H, Lammert F, Keitel V, Hutten MC, Pecks U. Management of Intrahepatic Cholestasis of Pregnancy: Recommendations of the Working Group on Obstetrics and Prenatal Medicine - Section on Maternal Disorders. Geburtshilfe Frauenheilkd. 2021 Aug;81(8):922-939. doi: 10.1055/a-1386-3912. Epub 2021 Aug 9. | |
| 18232463 |
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| ID | Term |
|---|---|
| C535932 | Intrahepatic Cholestasis of Pregnancy |
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Serum, stool, placenta
The bile acid profile in stool is an exploratory outcome measure that examines the composition and concentration of various bile acids in stool samples.
| 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). | Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion |
| Shao Y, Yao Z, Lu J, Li H, Wu W, Ding M. [Change of heart rate power spectrum and its association with sudden death in the fetuses of rats with intrahepatic cholestasis of pregnancy]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2007 Dec;24(6):1215-9. Chinese. |
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