Bile acid patterns in intrahepatic cholestasis of pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect maternal and fetal blood samples, maternal stool, and fetal heart rate monitoring (CTG) to profile bile acid types and concentrations and to link those patterns to clinical outcomes. Investigators will compare taurine- versus glycine-conjugated bile acids, test for activation of the TGR5 receptor, and analyze maternal gut microbiome relationships to bile acid patterns. The protocol includes control groups of healthy pregnant and non-pregnant adults to establish baseline bile acid and microbiome signatures. Data will be correlated with fetal monitoring findings and pregnancy outcomes to see if specific patterns identify higher-risk pregnancies.

Why it matters

Who can join: the full rules

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)

Where it's running

• Klinik für Geburtsmedizin, Universitätsklinikum Jena
  Jena, Thuringia, Germany Recruiting

Study contacts

• Study coordinator: Silke Große, Dr. rer. nat.
• Email: silke.grosse@med.uni-jena.de
• Phone: +493641 9-329293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.