| CTRI Number |
CTRI/2024/11/077111 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The development of a tool to study the emotional experiences of women in the postpartum period |
|
Scientific Title of Study
|
Development and validation of a tool to assess for postpartum experiences |
| 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 Shiva Prakash Srinivasan |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Sree Vikas Centre for Hormones and Mental health |
| Address |
Survey no 85 by 89, Plot B, Brindavan Street, Srinivasa Nagar, Madipakkam
Chennai TAMIL NADU 600091 India |
| Phone |
9380055736 |
| Fax |
|
| Email |
drsshivaprakash@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shiva Prakash Srinivasan |
| Designation |
Consultant psychiatrist |
| Affiliation |
Sree Vikas Centre for Hormones and mental health |
| Address |
Survey no 85 by 89, Plot B, Brindavan Street, Srinivasa Nagar, Madipakkam
Chennai TAMIL NADU 600091 India |
| Phone |
9380055736 |
| Fax |
|
| Email |
drsshivaprakash@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shiva Prakash Srinivasan |
| Designation |
Consultant psychiatrist |
| Affiliation |
Sree Vikas Centre for Hormones and mental health |
| Address |
Survey no 85 by 89, Plot B, Brindavan Street, Srinivasa Nagar, Madipakkam
Chennai TAMIL NADU 600091 India |
| Phone |
9380055736 |
| Fax |
|
| Email |
drsshivaprakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Good Folks Fashion Private limited, 235, Dwaraka Sector 28, New Delhi 110077 |
|
|
Primary Sponsor
|
| Name |
Good folks fashion private limited |
| Address |
235, Dwaraka Sector 28, New Delhi 110077 |
| Type of Sponsor |
Other [Private limited company] |
|
|
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 Balakumari |
Velachery KS hospital |
Obstetrics Department,
14, 10th Cross Street, 1st ext, AGS colony, Velachery Chennai TAMIL NADU |
9840086564
drkbalakumari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Fertility Centre (A unit of A4 Hospital) IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post partum mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
- Post partum mothers with infants between the ages 1 month to 1 year
- they may or may not have symptoms or treatment for postpartum depression |
|
| ExclusionCriteria |
| Details |
- not consenting for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- subjective information about experiences in the post partum period
- creation of a valid and contextually relevant tool to assess emotional and behavioral symptoms in the post partum period |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="520" Sample Size from India="520"
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)
|
02/12/2024 |
| 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="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
While multiple tools have diagnostic validity and support the screening for PPD, one of the key
challenges has been that they do not entirely capture the subjective
experiences of women in the postpartum period. The evaluation of the subjective
experiences of depression has value in identifying the key target areas that
would need to be addressed in the postpartum period to ensure that the women
who are suffering from a gamut of mood problems receive the most appropriate
and targeted care as needed. This research project will be conducted in 2 phases - phase one qualitative - where using semistructed interviews, and phenomenological analysis, we will evaluate the experiences of postpartum mothers in the context of their psycho-social environment. in the second phase, the quantitative phase, we will use the tool created from the learnings of the qualitative phase and factor analysis, comprising both exploratory
factor analysis (EFA) and confirmatory factor analysis (CFA), will be performed
to determine the underlying factors of the new tool. This analysis will involve
assessing and validating the tool’s various dimensions. A ROC analysis
will be conducted to assess the predictive performance of the new tool,
including its sensitivity, specificity, and optimal
threshold cut-off values. the results will be published in peer reviewed journals and in presented in conferences. |