Bile acid patterns in intrahepatic cholestasis of pregnancy
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
This study will test whether measuring different bile acids in pregnant people with intrahepatic cholestasis can help predict risks to the baby such as stillbirth or heart rhythm problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 1 site (Jena, Thuringia) |
| Trial ID | NCT07428226 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Pregnant people aged 18 or older with suspected or confirmed intrahepatic cholestasis of pregnancy, elevated total bile acids or liver enzymes, or pruritus with elevated transaminases would be the primary candidates.
Not a fit: People without ICP, with normal bile acids, or those unable to attend the Jena clinic visits are unlikely to receive direct clinical benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify pregnancies at higher risk so clinicians can monitor and intervene earlier to reduce fetal complications.
How similar studies have performed: Previous studies have linked very high total bile acid levels to increased fetal risk, but using detailed bile acid composition, TGR5 activation, and stool microbiome correlations to predict outcomes is relatively novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jena, Thuringia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.