FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095093 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study of Liver Disorders in Pregnancy and Fetomaternal Outcomes 
Scientific Title of Study   Study of Liver Disorders in Pregnancy and Fetomaternal Outcomes 
Trial Acronym  nil  
Secondary IDs if Any  
Secondary ID  Identifier 
nil   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vangala uday kumar  
Designation  Senior Resident  
Affiliation  Jawaharlal Nehru Medical Collage Wardha  
Address  Jawarlal Nehru Medical Collage Department of Medical Gastroenterology C block first floor Sawangi Wardha Maharatsra 442003
Jawarlal Nehru Medical Collage Department of Medical Gastroenterology C block First floor Sawangi Wardha Maharatsra 442003
Wardha
MAHARASHTRA
442003
India 
Phone  8142525678  
Fax    
Email  udai.reddii@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  DR Vijendra Kirnake  
Designation  HOD Medical gastroenterology 
Affiliation  Jawaharlal Nehru Medical Collage Wardha 
Address  Jawaharlal Nehru Medical Collage C block First Floor Sawangi Wardha Maharastra 442003
Jawaharlal Nehru Medical Collage C block first floor Sawangi Wardha Maharastra 442003
Wardha
MAHARASHTRA
442003
India 
Phone  7768901370  
Fax    
Email  drvijendrakirnake@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Vangala Uday Kumar  
Designation  Senior Resident  
Affiliation  Jawaharlal Nehru Medical Collage wardha  
Address  Jawaharlal Nehru Medical Collage Sawangi Wardha Maharastra 442003
Jawaharlal Nehru Medical Collage Sawangi Wardha Maharastra 442003
Wardha
MAHARASHTRA
442003
India 
Phone  8142525678  
Fax    
Email  udai.reddii@gmail.com   
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical Collage Wardha Sawangi Wardha Maharatra 442003 India  
 
Primary Sponsor  
Name  Dr Vangala Uday Kumar  
Address  Jawaharlal Nehru Medical Collage Sawangi Wardha Maharatra 442003 
Type of Sponsor  Other [observational study ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uday   Jawarlal Nehru Medical Collage Wardha   Department of Medical gastroenterology C block First floor
Wardha
MAHARASHTRA 
8142525678
-
udai.reddii@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K769||Liver disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  pregnant women attending antenatal clinic  
 
ExclusionCriteria 
Details  women whose foetuses were diagnosed with structural or chromosomal anomaly
patients not willing for study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the Prevalence and Differentiating between common causes of pregnancy related liver diseases.   During Antenatal Period and Post Partal period Upto 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
nil   nil  
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Liver disease in pregnancy can have serious consequences and can be a challenge

for health care providers. The cause of liver disease in pregnancy may be difficult to

diagnose and making the correct diagnosis is of paramount importance, as failure to

do so can result in morbidity or mortality for not only the mother but also for her

fetus.

Although there are alterations in normal physiological and hormonal profiles

throughout the pregnancy, there are few alterations in the results of standard liver

tests, however up to 3% of all pregnancies are complicated by liver disorders.

Severe liver disease, although rare, can occur and leads to increased morbidity and

mortality for both mother and newborn infant.The amino-transferases (AST and

ALT), G-glutamyl transpeptidase (GGTP), total bilirubin, and serum bile acid level

remain within the normal range. The alkaline phosphatase rises modestly in the third

trimester. The albumin level is lower than in non pregnant women, and the

cholesterol level is higher.

Liver involvement in pregnancy is of three types, namely liver disease unique to

pregnancy, liver disease coincidental to pregnancy, and pregnancy in patients with

pre-existing liver disease. The liver diseases unique to pregnancy include

hyperemesis gravidarum, acute fatty liver of pregnancy, Intrahepatic cholestasis of

pregnancy (ICP), and pregnancy induced hypertension (PIH) related dysfunction

including pre-eclampsia and HELLP syndrome ( hemolysis, elevated liver enzymes

and low platelets). Liver disease such as acute viral hepatitis can occur in pregnancy,

and pregnancy may occur in a patient with underlying chronic liver disease,including patients with cirrhosis and portal hypertension, and patients who have

undergone liver transplantation.

There are only very few studies available about the frequency, etiological profile,

outcome, and management guidelines for pregnancy related liver disease in India.

We therefore will prospectively study the spectrum of liver disease in pregnancy and

their maternal and fetal outcome

 
Close