Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID07428226

Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

Led by Jena University Hospital · Updated on 2026-02-23

74

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether analyzing bile acid patterns can help predict serious complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that may affect the baby. This observational study also explores if these bile acid patterns activate certain receptors that could cause immune or heart rhythm problems in the baby, and how the mother's gut bacteria relate to ICP severity. The study compares three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. Participants will provide blood samples during routine bile acid checks throughout pregnancy and at delivery, stool samples to study gut bacteria and bile acids, and baby's umbilical cord blood at birth. They will have standard heart rate monitoring (CTG) and an ultrasound of the baby's heart (echocardiography). The study aims to see if combining heart rate monitoring with bile acid measurements better identifies high-risk pregnancies. During the study, researchers will monitor bile acid profiles from inclusion to delivery for pregnant women and at inclusion for non-pregnant women. They will also assess receptor activity, bile acid levels in stool, and bile acid transfer between mother and baby. Participants can expect regular sample collections and standard heart and ultrasound exams. The study will help clarify how bile acid patterns relate to pregnancy risks in ICP.

CONDITIONS

Brief Title

Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Confirmed pregnancy
  • Generally considered healthy (ASA II classification)
  • Female gender for non-pregnant group
  • Pregnancy excluded for non-pregnant group
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Inability to provide informed consent
  • Signs of an acute illness (for healthy pregnant and non-pregnant groups)
  • Known liver, biliary, or pancreatic diseases (for healthy pregnant and non-pregnant groups)
  • ICP in personal or family medical history (for healthy pregnant and non-pregnant groups)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From inclusion to delivery for pregnant participants; single timepoint at inclusion for non-pregnant participants

Participants are observed from inclusion until delivery or at inclusion for non-pregnant controls to assess bile acid profiles and related measures.

Multiple visits until delivery for pregnant participants; 1 visit for non-pregnant participants

Trial Site Locations

Total: 1 location

1

Klinik für Geburtsmedizin, Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

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Research Team

S

Silke Große, Dr. rer. nat.

J

Janine Zöllkau, Dr. med.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Management of Intrahepatic Cholestasis of Pregnancy: Recommendations of the Working Group on Obstetrics and Prenatal Medicine - Section on Maternal Disorders.

Carsten Hagenbeck, Amr Hamza, Sven Kehl...

https://pubmed.ncbi.nlm.nih.gov/34393256

[Change of heart rate power spectrum and its association with sudden death in the fetuses of rats with intrahepatic cholestasis of pregnancy].

Yong Shao, Zhenwei Yao, Jie Lu...

https://pubmed.ncbi.nlm.nih.gov/18232463

Fetal cardiac dysfunction in intrahepatic cholestasis of pregnancy is associated with elevated serum bile acid concentrations.

Tharni Vasavan, Sahil Deepak, Indu Asanka Jayawardane...

https://pubmed.ncbi.nlm.nih.gov/33276032

Differences in Fecal Gut Microbiota, Short-Chain Fatty Acids and Bile Acids Link Colorectal Cancer Risk to Dietary Changes Associated with Urbanization Among Zimbabweans.

L Katsidzira, S Ocvirk, A Wilson...

https://pubmed.ncbi.nlm.nih.gov/31007075

Dietary Lactobacillus reuteri prevent from inflammation mediated apoptosis of liver via improving intestinal microbiota and bile acid metabolism.

Zishen Lin, Jianmin Wu, Jinping Wang...

https://pubmed.ncbi.nlm.nih.gov/36283304

Bacterial and metabolic phenotypes associated with inadequate response to ursodeoxycholic acid treatment in primary biliary cholangitis.

Laura Martinez-Gili, Alexandros Pechlivanis, Julie A K McDonald...

https://pubmed.ncbi.nlm.nih.gov/37191344