| CTRI Number |
CTRI/2025/10/095557 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
CROSS SECTIONALSTUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the knowledge of postgraduate residents regarding various neurological complications that can occur in pregnant patients |
|
Scientific Title of Study
|
A study to evaluate the knowledge of postgraduate residents regarding various neurological complications observed in pregnant patients |
| 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 Asha |
| Designation |
Assistant Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS, ROHTAK |
| Address |
Department of Anesthesia and critical care, PGIMS, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9729613310 |
| Fax |
|
| Email |
ASHIASHA133@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha |
| Designation |
Assistant Professor |
| Affiliation |
Pt B.D. Sharma PGIMS, ROHTAK |
| Address |
Department of Anesthesia and Critical care, PGIMS, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9729613310 |
| Fax |
|
| Email |
ASHIASHA133@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha |
| Designation |
Assistant Professor |
| Affiliation |
Pt. B.D.Sharma PGIMS, ROHTAK |
| Address |
Department of Anesthesia and Critical care, PGIMS, ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9729613310 |
| Fax |
|
| Email |
ASHIASHA133@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Asha Assistant Professor Department of Anesthesiology critical care PGIMS Rohtak |
| Address |
PT. B. D. Sharma PGIMS, Rohtak Haryana |
| 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 MONIKA |
PT. B. D. Sharma PGIMS, Rohtak124001 |
Department of Anesthesia and Critical care
Rohtak
HARYANA |
9671436493
drmonikayadav243@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOMEDICAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ANAESTHESIA RESIDENT ENROLLED IN THE COURSE OF M. D. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Residents of anesthesiology after 6 months of enrolment |
|
| ExclusionCriteria |
| Details |
RESIDENT REFUSAL TO PARTICIPATE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the knowledge of post graduate residents regarding various neurological complications (preeclampsia, eclampsia, PRES, CVST, stroke, pituitary apoplexy, HEELP syndrome) observed in pregnant patients. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To create awareness regarding various neurological complications observed in pregnant patients. |
At Baseline |
| To highlight importance of timely neurological examination in such patients. |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Women in pregnancy and puerperium represent a critical category of patients whose diagnostic and therapeutic management impacts neonatal outcome. Postgraduate students of departments of Obstetrics & gynaecology and Anaesthesiology & Critical care are directly involved in the management of these patients. Awareness regarding the neurological complications is essential as it will help in decreasing maternal and neonatal morbidity and mortality. This study will be done to assess the current knowledge about neurological complications in pregnant patients among these residents. |