| CTRI Number |
CTRI/2024/12/077584 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Obstetric admissions to intensive care units in India |
|
Scientific Title of Study
|
Obstetric admissions to intensive care units in India: a retrospective registry-based data analysis
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 406, Academic Block
Deoartment of Anesthesia & Critical Care
AIIMS Bhubaneswar , Sijua, Patrapada
Khordha
ORISSA
751024
India |
| Phone |
08763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 406, Academic Block
Department of Anesthesia and Critical care
AIIMS Bhubaneswar , Sijua, Patrapada
Khordha
ORISSA
751024
India |
| Phone |
08763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swagata Tripathy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room 406, Academic Block
Department of Anesthesia & Critical Care
AIIMS Bhubaneswar , Sijua, Patrapada
Khordha
ORISSA
751024
India |
| Phone |
08763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Odisha, India, 751019 |
|
|
Primary Sponsor
|
| Name |
Swagata Tripathy |
| Address |
Room 406 , Academic Block, Department of Anesthesia & Critical Care, AIIMS Bhubaneswar, Odisha, India, 751019 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Swagata Tripathy |
AIIMS Bhubaneswar |
Room 406, Academic Block
AIIMS Bhubaneswar , Sijua, Patrapada
Khordha
ORISSA |
08763400534
tripathyswagata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O909||Complication of the puerperium, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 15-49 years, admitted to ICU between 2019 and 2024, classified as pregnant, postpartum or with an obstetric-related diagnosis. This cohort will be compared to non-pregnant women of the same age group. |
|
| ExclusionCriteria |
| Details |
Not meeting inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Describe demographics, diagnostic categories, illness severity and outcomes for anyone that has pregnancy or peripartum situation listed as a co-existing state in IRIS, such as (AFLP, Eclampsia, peripartum cardiomyopathy.)
|
At ICU Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ii. Describe demographics, illness severity & outcomes for those with non-pregnancy-related critical illness
iii. Compare case mix, characteristics & outcomes for pregnant & non-pregnant critically ill women in the age group of 15-49
|
At ICU & Hospital Discharge |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
14/12/2024 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Studies have explored the epidemiology and case mix of obstetric patients admitted to intensive care units (ICUs) [1-3], but multicentric longitudinal data from ICUs that focus on critical care case mix and resource utilisation is limited. Systematic reviews, including a meta-analysis by our team, show greater admissions and mortality within limited data from low- and middle-income countries of obstetric patients admitted to the ICU. [4] Hypertensive disease of pregnancy and haemorrhage constitute the leading causes of ICU admissions [3], but data are lacking about the other contributing factors, interventions, mechanical ventilation and complications. Since 2019, we have maintained a registry of critically ill patients admitted to ICU. We plan to undertake a registry-based retrospective data analysis of all obstetric and peripartum patients admitted to the Intensive Care Units (ICU) of the Department of Anesthesia & Critical Care at AIIMS Bhubaneswar, and data entered into the Indian Registry of Intensive Care (IRIS). |