Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
This study is investigating a liver condition called Intrahepatic Cholestasis of Pregnancy (ICP). In ICP, bile acids build up in the mother's blood, which can be risky for the baby, potentially leading to premature birth or stillbirth. The main goal is to find out if looking at different types of bile acids in a mother's blood, baby's umbilical cord blood, and the mother's stool can help doctors predict which babies are most at risk. Researchers also want to see if these bile acids affect certain health issues in the baby. By understanding this, doctors hope to identify high-risk pregnancies earlier and take steps to prevent serious complications, ultimately aiming to improve outcomes for mums and babies affected by ICP.
At a glance
What is this study about?
This study is for pregnant women who have, or might have, a liver condition called Intrahepatic Cholestasis of Pregnancy (ICP). In ICP, substances called bile acids, which normally help with digestion, build up in the mother's bloodstream. This build-up can unfortunately pose serious risks to the baby, such as them being born too early, having heart rhythm problems, or in rare cases, even stillbirth.
Currently, it's often hard to tell which pregnancies with ICP are most at risk using regular checks like heart rate monitoring. This study hopes to change that. Researchers want to see if looking at very specific patterns of bile acids in the mother's blood and stool, and the baby's umbilical cord blood after birth, can help predict these complications earlier. They are also investigating if these bile acids might trigger certain problems for the baby, like immune issues or heart rhythm changes.
By comparing these bile acid patterns in women with ICP, healthy pregnant women, and healthy women who aren't pregnant, the researchers hope to find better ways to spot high-risk situations. The aim is to give doctors more information so they can keep a closer eye on mums and babies who need it most, potentially preventing serious problems and leading to better health for everyone.
Key takeaways
- This study explores a pregnancy liver condition called ICP.
- It aims to find new ways to identify babies at higher risk in ICP.
- Researchers will study different types of bile acids in blood and stool.
- The goal is to prevent serious complications like stillbirth.
- Participation involves giving samples and having standard medical checks.
Who may be eligible?
To join this study, you need to be at least 18 years old. If you're pregnant, you might be able to participate if you have symptoms that suggest you have ICP, or if you've already been diagnosed with ICP. This includes if your bile acid levels or liver enzyme levels are high, or if you're experiencing itching along with high liver enzymes.
Even if you don't have ICP, you might be able to join as part of a 'comparison group'. This includes healthy pregnant women and healthy women who are not pregnant. These groups help the researchers compare the findings and understand what's different in women with ICP.
However, you can't participate if you are under 18, or if you have certain other liver, gallbladder, or pancreas conditions. If you're in the healthy comparison groups, you also can't have ever had ICP, or have acute (sudden and severe) illnesses.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Are you pregnant and have, or might have, ICP (e.g., itching with high liver enzymes or high bile acids)?
- Do you not have other known severe liver, gallbladder, or pancreas conditions?
- Are you able to give your full permission to take part?
What does participation involve?
If you decide to take part in this study, you would give blood samples at your usual antenatal appointments where your bile acids are checked, as well as when you deliver your baby. You would also be asked to provide stool samples, which will be analysed for bile acids and gut bacteria. After your baby is born, a small sample of blood will be taken from the umbilical cord.
Standard checks will also be done, including monitoring your baby's heart rate (called a CTG) and having an ultrasound of your baby's heart. There are no new medications to take as part of this study. The total duration of your participation would be throughout your pregnancy until delivery, with the samples collected at various routine points.
Potential risks and benefits
Locations (1)
- Klinik für Geburtsmedizin, Universitätsklinikum JenaVerified postcodeJena, Germany· Recruiting
Common questions
What is Intrahepatic Cholestasis of Pregnancy (ICP)?
It's a liver condition affecting some pregnant women, where bile acids build up in the mother's blood, which can be risky for the baby.
What is the main goal of this study?
The study aims to see if analysing bile acid patterns can predict complications in babies of mothers with ICP, helping doctors monitor them better.
Will I have to take any new medicines?
No, this study does not involve taking any new medications. It focuses on collecting samples and doing standard checks.
What kind of samples will be collected?
You'll provide blood samples at routine checks and delivery, stool samples, and your baby's umbilical cord blood at birth.
Can I stop participating in the study if I change my mind?
Yes, you can withdraw from the study at any time without it affecting your medical care.
How to find out more
Silke Große, Dr. rer. nat.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.