| 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
|
|
|
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
|
|
|
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. |