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临床试验/NCT07428226
NCT07428226招募中不适用

Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

Jena University Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
74
试验地点
1
主要终点
bile acid profile

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

Healthy non-pregnant controls

Healthy woman which are not pregnant

Pregnant ICP patients

Diagnosis or suspicion of an ICP according to Hagenbeck et al. 2021

Healthy pregnant controls

Healthy patients with a confirmed pregnancy

结局指标

主要结局

bile acid profile

时间窗: Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion

Qualitative and quantitative bile acid profile in serum of mother and infant (umbilical cord blood)

次要结局

  • TGR-5 activity(Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion)
  • bile acid profile in stool(Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion)
  • materno-fetal bile acid transfer rate (bile acid profile)(Pregnant women: from inclusion to delivery; Non-pregnant female volunteers: at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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