| 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
|
|
|
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
|
|
|
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. |