| CTRI Number |
CTRI/2024/04/066297 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Did covid affect pregnant women as much as it as thought it would? |
|
Scientific Title of Study
|
Clinical characteristics of obstetric patients admitted in ICU during covid pandemic and its comparison with the pre-covid period-a retrospective 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 |
Dr Eman Aftab |
| Designation |
Drnb Neuroanesthesia |
| Affiliation |
Shere-e-kashmir institute of medical sciences |
| Address |
Ward 2A, NICU, ward block, department of Anesthesia, Sher-e-kashmir institute of medical sciences,Soura
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
9858185001 |
| Fax |
|
| Email |
justme_eman@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aftab Ahmad Khan |
| Designation |
Professor Anesthesia |
| Affiliation |
Gmc srinagar |
| Address |
Room 110, department of Anesthesia ,GMC Srinager
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
9419001157 |
| Fax |
|
| Email |
draftabkhan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Eman Aftab |
| Designation |
Drnb Neuroanesthesia |
| Affiliation |
Shere-e-kashmir institute of medical sciences |
| Address |
Ward 2A, NICU, ward block, department of Anesthesia, Sher-e-kashmir institute of medical sciences,Soura
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
9858185001 |
| Fax |
|
| Email |
justme_eman@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GMC Srinagar,karannager, Jammu and kashmir, 190008,India |
|
|
Primary Sponsor
|
| Name |
government medical college |
| Address |
KARANNAGER, 190008, JAMMU AND KASHMIR, INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Eman Aftab |
GMC Srinagar |
Room 222,Intensive care unit,EOT block,2nd floor,department of Anesthesia, Lala hospital, part of GMC Srinagar and associated hospitals
Srinagar
JAMMU & KASHMIR |
9858185001
justme_eman@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Gmc Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
All obstetric patients admitted in icu will be considered |
|
| ExclusionCriteria |
| Details |
Gynae patients will be excluded out of the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of obstetric patients in ICU during covid |
Retrospective study of 4 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical characteristics of patients admitted |
6 years retrospective study |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
06/05/2024 |
| 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="4"
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
|
This is a retrospective, ICU register based study, where data will be collected from obstetric Icu of about total 4 yrs. 2 before covid and 2 during covid and both the data will be compared with each other.
|