| CTRI Number |
CTRI/2021/03/032223 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
SOCIAL AND PYSCHOLOGICAL CHANGES IN POSTPARTUM WOMEN DURING COVID-19 PANDEMIC |
|
Scientific Title of Study
|
MENTAL HEALTH OF POSTPARTUM WOMEN DURING COVID-19 PANDEMIC |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SR Mudanur |
| Designation |
Professor and HOD |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8106725928 |
| Fax |
|
| Email |
drmudanurs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SR Mudanur |
| Designation |
Professor and HOD |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8106725928 |
| Fax |
|
| Email |
drmudanurs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Latha Varma |
| Designation |
Junior Resident |
| Affiliation |
BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
Bijapur
KARNATAKA
586103
India |
| Phone |
8106725928 |
| Fax |
|
| Email |
klathavarma25@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE (DEEMED TO BE UNIVERSITY) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
|
|
Primary Sponsor
|
| Name |
DR S R Mudanur |
| Address |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
|
| Type of Sponsor |
Other [self funding] |
|
|
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 sr mudanur |
shri BM Patil Medical college |
Department of Obstetrics and gynecology, Room number 2, BLDE (deemeed to be university)Shri B M Patil Medical College smt. banagaramma sajjan campus Bijapur KARNATAKA
Bijapur
KARNATAKA |
8106725928
drmudanurs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
all postpartum women who have delivered within 7 days postpartum |
|
| ExclusionCriteria |
| Details |
women with known pyschiatric conditions
women who delivered postpartum psychosis
women enable to respond due to any acute medical conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the mental health of post partum women during covid-19 pandemic |
ON IMMEDIATE POSTPARTUM DAY AND AGAIN AFTER 2 WEEKS POSTPARTUM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study prevalence of psychiatric morbidity among post partum women |
POSTPARTUM IMMEDIATE DAY AND 2 WEEKS POSTPARTUM |
|
|
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)
|
31/03/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infectious disease outbreaks are known to have psychiological impact on healthcare workers as well as the generation population. the covid-19 pandemic has changed the healthcare landscape for many patient populations-including postpartum women. |