Intrahepatic Cholestasis of Pregnancy

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Review clinical trials related to Intrahepatic Cholestasis of Pregnancy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population

Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol/L (and elevated serum transaminases), with increased risks of perinatal complications, including spontaneous preterm labor, fetal distress, infant respiratory distress syndrome, meconium-stained liquor (MSL), and sudden intrauterine death (IUD). The Incidence of ICP varies from 0.1 to 15.6% of all pregnancies, with the highest cases in Chile, South Asia, America, and Scandinavia. The burden of ICP in India according to various states is as follows Punjab (3.1%), Chandigarh (4.8%), Delhi (0.79%), West Bengal (3.3%), and Lucknow (Uttar Pradesh) (2.8%).

Participants needed: 150
Trial details
Age: 21-45Biological sex: FemaleType: ObservationalSponsor: Post Graduate Institute of Medical Education and Research, ChandigarhUpdated: May 18, 2026Locations: 1
Eligibility criteria

Age > 21 years with consistent pruritus [+4]

Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus... [+8]

Status: Not yet recruiting

The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy

To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.

Participants needed: 160
Trial details
Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Tianjin Medical University General HospitalUpdated: May 1, 2026Locations: 1
Eligibility criteria

Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy. [+5]

Those who are known to be allergic to the drug components or have an allergic co... [+9]

Status: Recruiting

Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy

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.

Participants needed: 74
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: Jena University HospitalUpdated: Feb 23, 2026Locations: 1
Eligibility criteria

Minimum age of 18 years [+15]

Age <18 years [+4]

Status: Not yet recruiting

Maralixibat for Intrahepatic Cholestasis of Pregnancy

An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability

Participants needed: 28
Trial details
Phase: Phase 2Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Imperial College LondonUpdated: Feb 5, 2026Locations: 2
Eligibility criteria

Provide signed informed consent and be willing to comply with all study visits a... [+4]

At the time of either the screening or baseline visit, decision has already been... [+3]