FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078437 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed Method Study Design 
Study Design  Other 
Public Title of Study   Development of a Comprehensive Patient-Reported Postpartum Health Scale (CPR-PPHS) for Indian women 
Scientific Title of Study   Development and psychometric evaluation of a Comprehensive Patient-Reported Postpartum Health Scale (CPR-PPHS) for Indian women-Mixed method study design 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Esha Shetty 
Designation  Assistant Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  6th floor , School of Physiotherapy , School of Medicine Building , D.Y.Patil Deemed to Be University, Nerul ,Navi Mumbai -400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9632265857  
Fax    
Email  esha.shetty2301@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  6th floor , School of Physiotherapy , School of Medicine Building , D.Y.Patil Deemed to Be University, Nerul ,Navi Mumbai -400706

Mumbai
MAHARASHTRA
400706
India 
Phone  8452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Esha Shetty 
Designation  Assistant Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  6th floor , School of Physiotherapy , School of Medicine Building , D.Y.Patil Deemed to Be University, Nerul ,Navi Mumbai -400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9632265857  
Fax    
Email  esha.shetty2301@gmail.com  
 
Source of Monetary or Material Support  
Self Suppported, No external support 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Anu Arora  D.Y Patil Hospital & Research Centre  D.Y.Patil Hospital & Research Centre, 3rd floor Multidisciplinary Physiotherapy OPD, Sector 5 , Nerul , Navi Mumbai
Thane
MAHARASHTRA 
8452842895

esha.shetty2301@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee for Biomedical Health Research - D.Y. Patil Deemed to be University,School of Medicine,Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Postpartum females 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  postpartum women from the time of delivery to one year who will give consent 
 
ExclusionCriteria 
Details  Postpartum mothers with their baby in NICU  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Physical heath, mental health, social health, infant care needs, return to work  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Satisfaction with the available care   Baseline 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   15/01/2025 
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)   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  

Postpartum period is the period right after birth to a duration of 6 months to 1 year when the women’s body starts returning to its pre-pregnancy physiological and anatomical condition.A mother, during the postpartum period, bears a double burden of physical changes and psychosocial factors.The additional responsibility of providing appropriate care to the newborn, inadequate sleep, fatigue, and less time for self care while satisfying the basic role toward the family members, may lead to emotional letdown and depressive symptoms among mothers , contributing to poor Quality of life which eventually might have impact on their functioning and health.

Assessment is an inseparable part of effective & efficient management.Patient–reported outcome reflects a shift to a more patient centric model of health care delivery and provides information that is of value to both the patient and the therapist.Outcome from the person’s perspective is increasingly being recognised as pivotal in understanding the impact of an disease or condition on the individual and has a direct influence on the clinical decision-making process.

Postpartum health and function is still not clearly defined and also systematic reviews (2022,2021) conducted on the use of outcome measures to assess postpartum health and recovery have stated a need to systematically develop and validate a robust patient reported outcome measure to assess postpartum health . Studies evaluating overall health during the postpartum period in India have been very limited because of the lack of availability of a validated instrument.Also, as with many other outcome measures , the postpartum assessment is mainly focused based on the Western population and their cultural factors, which is being followed by us. There is also a lack of an outcome measure that assess all the domains of postpartum health considering the cultural and contextual factors with respect to the Indian population. 

Hence, in the view of the existing gaps in assessment of postpartum health , there is a need to develop and psychometrically evaluate a Comprehensive Patient Reported Postpartum Health Scale (CPR-PPHS) for Indian Women keeping in mind the biopsychosocial model which in future would help physiotherapists  target overall  postpartum health thus enhancing the efficiency of the management practices. 

 
Close