Cholestasis Clinical Trials

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Bile Acids Metabolism and Genetic Mutation Profile in the Etiopathogenesis of Intrahepatic Cholestasis of Pregnancy in Indian Population- A Prospective Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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%).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 45
Healthy Volunteers: t
View:

• Age \> 21 years with consistent pruritus

• Characterized by consistent pruritus associated with elevated levels of serum transaminases (ALT \> 40 U/L or AST \> 37 U/L) or raised total serum bile acids (≥ 10 µmol/L)

• Able to understand and comply with the requirements of the study and voluntarily agrees to participate in the study by giving written informed consent before any study-related activity is performed

• Voluntary informed consent to participate until their delivery and also willing to be followed until their delivery

• Agrees to provide information on perinatal and maternal outcomes at or after delivery

Locations
Other Locations
India
Dr. Madhumita Premkumar
RECRUITING
Chandigarh
Contact Information
Primary
Dr Madhumita Premkumar, DM
drmadhumitap@gmail.com
7087003409
Backup
Jasvinder Nain, MPH
jasvindernain1506@gmail.com
Time Frame
Start Date: 2022-12-08
Estimated Completion Date: 2026-07
Participants
Target number of participants: 150
Treatments
Pregnant women with ICP
Case: Pregnant women with consistent pruritus or on medication for pruritus associated with an elevated level of serum transaminase alanine transaminase(ALT)\>40 IU/L or aspartate transaminase(AST)\>37 IU) and raised serum bile acids ≥10µmol/L will be eligible for the inclusion in the study.
Pregnant women without ICP
Controls: Healthy pregnant women of the same gestational age with routine physical examinations will be enrolled as a control group.
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov