FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082994 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 03/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Ambispective descriptional 
Study Design  Single Arm Study 
Public Title of Study   Outcomes in the mother and newborn in pregnant patients having portal hypertension.  
Scientific Title of Study   Maternal and Fetal outcome in pregnancies complicated by portal hypertension. An observational study. 
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 Bodicherla Bhuvana Sai  
Designation  Junior resident  
Affiliation  JIPMER 
Address  Department of obstetrics and gynaecology Women and childrens hospital

Pondicherry
PONDICHERRY
605006
India 
Phone  8309488351  
Fax    
Email  bvnsai0601@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dilip Kumar Maurya 
Designation  Professor  
Affiliation  JIPMER  
Address  Department of obstetrics and gynaecology Women and childrens hospital JIPMER


PONDICHERRY
605006
India 
Phone  9442136037  
Fax    
Email  dilipkm2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bodicherla Bhuvana Sai  
Designation  Junior resident  
Affiliation  JIPMER  
Address  Department of obstetrics and gynaecology Women and childrens hospital JIPMER


PONDICHERRY
605006
India 
Phone  8309488351  
Fax    
Email  bvnsai0601@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Puducherry, India 605006. 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantari Nagar, Puducherry, India 605006.  
Type of Sponsor  Research institution and hospital 
 
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 Bodicherla Bhuvana Sai  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of obstetrics and gynaecology Antenatal ward, ICU and HDU Women and children hospital.
Pondicherry
PONDICHERRY 		 8309488351

jr8415@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee for observational studies   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K766||Portal hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Portal hypertension diagnosed before or during pregnancy, irrespective of the cause  
 
ExclusionCriteria 
Details  1. Age < 18 years  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the maternal and fetal outcomes in pregnancies complicated by portal hypertension  Outcomes are assessed after delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the pregnancy outcome in women with cirrhotic, non-cirrhotic portal fibrosis (NCPF) & extrahepatic portal vein obstruction (EHPVO).
2. To assess the risk factors associated with variceal bleeding during pregnancies, among women with portal hypertension. 		 Outcomes are assessed after delivery.  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   22/03/2025 
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="2"
Months="6"
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  

Pregnant women with a diagnosis of portal hypertension, based on a history of GI bleed, jaundice, and ascites, presence of varices on endoscopy, presence of collaterals in spleno-portal axis and dilated portal vein, i.e., more than 13 mm on Doppler ultrasound8, will be identified from the admission records of the labour ward, antenatal wards, HDU, and the Obstetric Intensive Care Unit. Details of those who had undergone a portosystemic shunt surgery with/without splenectomy for portal hypertension and its complications will be recorded. The cause of portal hypertension will be recorded as – Cirrhotic or Non-cirrhotic. The non-cirrhotic will be further categorized into NCPF and EHPVO.  If the cause of cirrhosis is known that also will be collected.

Demographic details including age during pregnancy, parity, age at the time of diagnosis, clinical details such as etiology of portal hypertension, duration and course of the disease and management including medication, endoscopic findings, details of endoscopic or open surgery, sclerotherapy and the treatment received during pregnancy will be recorded. Medical complications like hematemesis, any massive bleed, anemia, severe thrombocytopenia, need for blood products, or any decompensation of hepatic function (clinical and/ or biochemical), obstetric complications during pregnancy including abortions, antepartum hemorrhage, hypertensive disorder of pregnancy and fetal growth restriction; the timing and mode of delivery, any peripartum complications such as postpartum hemorrhage, and the neonatal outcomes like birth weight, neonatal intensive care unit (NICU) admissions and deaths will be collected and analysed. The details of any complications till discharge form the hospital will be recorded.  
Close