Clinical trials: Obstetric Cholestasis
Intrahepatic Cholestasis of Pregnancy
Serum Autotaxin Levels in Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy.
- Trial name
- NCT02480478
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Intrahepatic Cholestasis of Pregnancy
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…
- Trial name
- BAPP (NCT07428226)
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Jena University Hospital
Intrahepatic Cholestasis of Pregnancy
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of…
- Trial name
- NCT04922580
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD
Intrahepatic Cholestasis of Pregnancy
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of…
- Trial name
- NCT01898832
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Intrahepatic Cholestasis of Pregnancy, Arrhythmia
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave…
- Trial name
- NCT01906827
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Parenteral Nutrition, Necrotizing Enterocolitis
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain.
- Conditions
- Parenteral Nutrition, Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392730
- Testing
- Remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Intrahepatic Cholestasis of Pregnancy
ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls
Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of…
- Trial name
- NCT00700232
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University Hospital, Tours
Premature Birth
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene…
- Trial name
- TPNAC (NCT01062724)
- Testing
- Primene 10 % from Baxter
- Where
- Mexico
- Volunteers
- 94 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University
Pregnancy Disease, Cirrhosis, Liver
Liver Disease in Pregnancy
Liver Diseases in pregnancy represents rare disorders and current data is derived primarily from single centres and retrospective cohorts.
- Conditions
- Pregnancy Disease, Cirrhosis, Liver, HELLP Syndrome, AFLP - Acute Fatty Liver of Pregnancy
- Trial name
- NCT03834285
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- King's College Hospital NHS Trust
Cholestasis, Intrahepatic Cholestasis of Pregnancy
Investigation of the Pruritogens of Liver-related Diseases
This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT06364969
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Peking University
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Intrahepatic Cholestasis of Pregnancy
MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in pregnant women with intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- OASIS (NCT07823127)
- Testing
- Maralixibat
- Volunteers
- 15 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis of Pregnancy
Association of Intrahepatic Cholestasis of Pregnancy and Chronic Placental Inflammation
This observational prospective study will help to determine if an immune process similar to allograft rejection is responsible for the occurrence of an intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- INTREPIDE (NCT05197387)
- Where
- 11 sites in France
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Intrahepatic Cholestasis of Pregnancy
The Microbiome Composition in Women With Recurring Intrahepatic Cholestasis of Pregnancy (ICP)
This is an exploratory non-therapeutic study to study the microbiome patterns during pregnancy in women with ICP in order to identify specific bacterial strains for further product development.
- Trial name
- NCT05151913
- Testing
- Exploratory
- Where
- 2 sites in Sweden
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- MetaboGen AB
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Intrahepatic Cholestasis of Pregnancy
Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy
This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP.
- Trial name
- NCT06366659
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Peking University
Intrahepatic Cholestasis of Pregnancy
The Use of Fish Oil Supplementation in Treatment of Intrahepatic Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy (ICP) is a unique disease of the liver resulting in abnormal bile acid levels and liver function. The incidence of ICP ranges from 0.1 - 15.6%.
- Trial name
- NCT01965054
- Testing
- Fish Oil Supplement Group
- Sponsor
- Icahn School of Medicine at Mount Sinai
Intrahepatic Cholestasis of Pregnancy
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
- Trial name
- METAPHOR (NCT07389031)
- Testing
- Maralixibat
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London