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CTRI Number  CTRI/2025/12/099757 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 23/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Outcome of critically ill obstetric patients admitted to the intensive care units in India 
Scientific Title of Study   Outcome of critically ill obstetric patients admitted to the intensive care units in India INDI-OBS STUDY 
Trial Acronym  INDI-OBS STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  ICU Block 4 th Floor Hero Heart Building Dayanand Medical College and Hospital Ludhiana
civil lines Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  09878645330  
Fax    
Email  gunchan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  ICU Block 4th Floor Hero Heart Building Dayanand Medical College and Hospital Ludhiana
civil lines Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  09878645330  
Fax    
Email  gunchan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  ICU Block 4th Floor Hero Heart Building Dayanand Medical College and Hospital Ludhiana
civil lines Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  09878645330  
Fax    
Email  gunchan@gmail.com  
 
Source of Monetary or Material Support  
Indian Society of Critical Care Society 
 
Primary Sponsor  
Name  Indian Society of Critical Care Spciety 
Address  unit 13 and 14 first floor Hind Services Industrial Premises Cooperative Society Near Chaitya Bhoomi Off Veer Savarkar Marg Dadar Mumbai 400028  
Type of Sponsor  Other [Non profit organization of experts in the field of Critical Care medicine] 
 
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 
Gunchan Paul  Dayanand Medical College and Hospital  ICU Block 4th floor Hero Hear Building
Ludhiana
PUNJAB 
09878645330

gunchan@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: O20-O29||Other maternal disorders predominantly related to pregnancy, (2) ICD-10 Condition: O10-O16||Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium, (3) ICD-10 Condition: O85-O92||Complications predominantly related to the puerperium, (4) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, (5) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  All Critically ill obstetric adult pregnant patients with more than 24 weeks of gestation and up to 42 days post delivery patient with SOFA Score more than equal to 6
 
 
ExclusionCriteria 
Details  Pregnancy less than 24 weeks of gestation or with any form of ectopic pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
maternal mortality at day 30 of critically ill obstetric patients admitted to ICU  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Length of ICU stay (days):  30 days 
Length of hospital stay (days):  30 days 
Neonatal Outcome  30 days 
Incidence of organ failure  30 days 
 
Target Sample Size   Total Sample Size="650"
Sample Size from India="650" 
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)   10/01/2026 
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 Applicable 
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  

Worldwide about half a million women die as results of complications of pregnancy and childbirth. In India many women die due to pregnancy-related complications and those who survive suffer from severe maternal morbidity.  Maternal mortality has been identified as a priority on health policy and research agendas for developing countries. Maternal mortality is a vital index of the effectiveness of obstetric services prevailing in country. Obstetric critically ill patients pose significant challenge due to physiological changes. It may become more challenging when comorbid conditions are present. Compared with non-pregnant women they experience considerably increased rates of mortality, receive organ supports for prolonged duration, have premature birth, and are at increased risk of fetal deaths. Obstetric patients in the intensive care unit needed specialized yet personalized care.

In the Indian healthcare settings, there are late referrals, resource constraints and increased burden of critically ill obstetric patients. There is an urgent need for timely obstetric critical care, structured triage systems, and region-specific data to drive policy in order to improve overall outcomes.

This study aimed to assess pregnancy outcomes and mortality in critically ill pregnant women in the Intensive Care Unit  and to provide valuable clinical insights for improving the management of obstetric emergency care, reducing maternal and neonatal adverse outcomes, and improving the level of obstetric care.

 
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