An observational study in Intrahepatic Cholestasis of Pregnancy, sponsored by Jena University Hospital. Recruiting at 1 site in Germany. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Jena University Hospital · Observational
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:
26 studies on the registry are indexed under Intrahepatic Cholestasis of Pregnancy; 10 are open to participants now.
This study's planned enrollment of 74 is below the median of 118 across 18 observational studies indexed under Intrahepatic Cholestasis of Pregnancy.
Browse Intrahepatic Cholestasis of Pregnancy studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria Group I:
Inclusion Criteria Group II:
Inclusion Criteria Group III:
Exclusion Criteria Group II and III:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnosis or suspicion of an ICP according to Hagenbeck et al. 2021
Healthy patients with a confirmed pregnancy
Healthy woman which are not pregnant
bile 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
Correlation between bile acid profiles and TGR5 activation
Time frame: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion
Plan to share: Undecided — The data concerns a vulnerable population (pregnant individuals and their newborns), which is why personal information is treated with particular sensitivity. The local data protection policy must be observed. In scientific cooperation, a release is conceivable after careful review and in accordance with legal, ethical, and organizational requirements.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Intrahepatic Cholestasis of Pregnancy →
Jena University Hospital