1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (NA).
   


6. For how long will this data be available start date provided 20-03-2024 and end date provided 19-03-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NA

Ø Intrahepatic cholestasis of pregnancy (IHCP) is the most common pregnancy-specific liver disease. It classically presents in the late second or early third trimester of pregnancy with pruritis, which typically involves the palms and soles, and is associated with deranged liver functions and elevated serum bile acids.  

Ø Altered bile acid metabolism with an accumulation of bile acid is detrimental to the foetus leading to increased perinatal morbidity and mortality in the form of preterm births, meconium, foetal distress, and stillbirths or intra-uterine death.

Ø A lot of work and research has been done but still, many questions remain unanswered as there is a constant fear of sudden foetal demise nearing term without any alarming signs and critical cut-off level of serum bile acid beyond which pregnancy should be terminated. 

As As per the latest data, in Indian Asians, the incidence ranges from 1.2 to 1.5%. It is also seen that more than 70% of IHCP occurs in the third trimester of pregnancy. 

Ø Recent studies believed that elevated BA levels can influence lipid and glucose metabolism in women with ICP. 

Ø Based on the results of several meta-analyses, it is revealed that women with ICP were more likely to have gestational diabetes mellitus (GDM). 

Ø Previous studies reported that ICP was not related to dyslipidaemia but some produces opposite results.

Therefore, this study is aimed to estimate the biochemical parameters associated with adverse foetal and maternal outcome so that we can come to a conclusion that whether this disease has association with liver, glucose and lipid metabolism. This will also help in developing novel targets for its management. 

Ø This study is also undertaken to know the current trends of foetal and maternal outcomes associated with intrahepatic cholestasis so that increased attention will be diverted to the important causative factors and foeto-maternal outcomes can be improved.