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NCT07428226: BAPP
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
trial in Intrahepatic Cholestasis of Pregnancy in 74 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Jena University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 74 |
| Start date | 1 July 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across Germany |
Conditions studied
- Intrahepatic Cholestasis of Pregnancy — all drugs for Intrahepatic Cholestasis of Pregnancy →
Sponsor
Jena University Hospital
Who can join
Adults 18 to 45, female only, with Intrahepatic Cholestasis of Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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: * Can measuring specific types of bile acids (particularly taurine-conjugated versus glycine-conjugated bile acids) in the mother's and baby's blood help predict the risk of stillbirth and other complications? * Do these bile acid patterns activate specific receptors (TGR5) that might contribute to immune problems or heart rhythm abnormalities in the baby? * How do bile acid patterns in the mother's stool relate to her gut bacteria and the severity of ICP? * Can heart rate monitoring (CTG) combined with bile acid measurements better identify high-risk pregnancies? ICP is a pregnancy-related liver condition that causes bile acids to build up in the mother's bloodstream. This can lead to serious risks for the baby, including an increased chance of stillbirth, premature birth, and heart rhythm problems. Current monitoring methods (such as heart rate monitoring and ultrasound) often don't show warning signs before complications occur. Participants will: * Provide blood samples at each routine bile acid check during pregnancy and at delivery * Provide stool samples for analyzing gut bacteria and bile acids * Have their baby's umbilical cord blood collected at birth for bile acid analysis * Undergo standard heart rate monitoring (CTG) of the baby * Have ultrasound examination of the baby's heart (echocardiography) The study will compare three groups: pregnant women with ICP, healthy pregnant women, and healthy non-pregnant women. The researchers hope this information will help doctors better predict which pregnancies need more intensive monitoring and potentially prevent stillbirths and other complications in women with ICP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07428226
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07428226 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jena University Hospital
- Last refreshed: 23 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07428226.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing