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Could bile acid fingerprints prevent stillbirths in pregnancy cholestasis?

NCT ID NCT07428226

Knowledge-focused Sponsor: Jena University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study is looking at pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that raises bile acids and can harm the baby. Researchers want to see if measuring specific bile acid types in the mother's and baby's blood can help predict serious complications like stillbirth. They will also check stool samples, heart rate monitoring, and ultrasound. The study compares three groups: women with ICP, healthy pregnant women, and healthy non-pregnant women.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict which pregnancies are at highest risk for stillbirth and other complications, leading to more targeted monitoring.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear patterns that improve prediction, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

intrahepatic cholestasis of pregnancy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrahepatic cholestasis of pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Klinik für Geburtsmedizin, Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

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