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%).
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
Viral and Infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) related liver disease, Epstein Barr virus (EBV), Cytomegalovirus (CMV), human immunodeficiency virus (HIV) infection) hepatitis C virus (HBV), hepatitis E virus (HEV)
Primary dermatologic diseases associated with pruritus
Metabolic diseases (including alcohol abuse)
Other causes of cholestasis (i.e., primary biliary cholangitis (PBC); primary sclerosing cholangitis (PSC)
Study Population: Group 1: Pregnant women with ICP, n= 75 Cases: Pregnant women with consistent pruritus or on medication for pruritus associated with an elevated level of serum transaminase (ALT\>40 IU/L or AST \>37 IU) and raised serum bile acids ≥10μmol/L will be eligible for inclusion in the study. Group 2: Pregnant women without ICP, n=75 Controls: Healthy pregnant women of the same gestational age with routine physical examinations will be enrolled as a control group. Setting: PGIMER (Chandigarh, India) Study Centre - Departments of Hepatology/ Obstetrics and Gynaecology, PGIMER, Chandigarh
Case-control
Prospective
Not listed
Profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.
Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)
Change in the profile of serum bile acids (conjugated and unconjugated) in patients with ICP (Intrahepatic cholestasis of pregnancy) and without ICP.
Bile acids profiling will be accessed by using liquid chromatography combined with mass spectrometry (LC-MS/MS)
Mode of delivery in the cohort of women with ICP.
During follow-up, delivery-related details such as mode of delivery, any postpartum hemorrhage or requirement for blood transfusion, gestational age at delivery, an indication of cesarean section, mode of induction of labor, duration of stages of labor and their association with intrahepatic cholestasis of disease and frequency in comparison to control/apparently healthy pregnant women.
Assessment of newborn physical and clinical profile.
Details related to newborns such as birth weight (in kg), height (in cm) and APGAR score, along with any adverse perinatal outcome such as stillborn, respiratory such as respiratory distress, fetal cardiac dysfucntion and other clinical condition will also be recorded and compared with apparently healthy control pregnant women.
At the baseline visit, measurement of pruritus of the visual analog scale (VAS).
Pruritus will be measured on 0-100mm scale.
Change in pruritus of the visual analog scale (VAS) at delivery.
Pruritus will be measured on 0-100mm scale.
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