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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
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