| CTRI Number |
CTRI/2024/12/078545 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on Postpartum Depression Among Urban and Rural Mothers in Pune, Maharashtra |
|
Scientific Title of Study
|
Postpartum Depression among Urban and Rural Mothers in Pune, Maharashtra: A Comparative Analytical Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Hemendra Satbhai |
| Designation |
PhD Scholar |
| Affiliation |
Dr. Vishwanath Karad MIT World Peace University |
| Address |
Department of Public Health, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, Maharashtra, 411038, India
Pune
MAHARASHTRA
411038
India |
| Phone |
7028101566 |
| Fax |
|
| Email |
seema.satbhai24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shamim Mohammad |
| Designation |
PhD Supervisor and associate Professor |
| Affiliation |
Dr. Vishwanath Karad MIT World Peace University |
| Address |
Department of Clinical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, Maharashtra 411038, India
Pune
MAHARASHTRA
411038
India |
| Phone |
8737069587 |
| Fax |
|
| Email |
shamim.mohd@mitwpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shamim Mohammad |
| Designation |
PhD Supervisor and associate Professor |
| Affiliation |
Dr. Vishwanath Karad MIT World Peace University |
| Address |
Department of Clinical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, Maharashtra 411038, India
Pune
MAHARASHTRA
411038
India |
| Phone |
8737069587 |
| Fax |
|
| Email |
shamim.mohd@mitwpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.Vishwanath Karad MIT World Peace Universit, Survey No.124, Paud Road, Kothrud, Pune,Maharashtra 411038 India |
|
|
Primary Sponsor
|
| Name |
Seema Hemendra Satbhai |
| Address |
Department of Public Health, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT World Peace University, Kothrud, Pune, Maharashtra, 411038, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Seema Hemendra Satbhai |
Khadakwasala Primary Health Centre |
Out Patient Department, Vaccination room, Khadakwasala Pune, Maharashtra, 411023, India
Pune
MAHARASHTRA |
7028101566
seema.satbhai24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of MAEERS Vishwaraj Hospital |
Approved |
| SHSRC Approval Letter |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum Depression |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1)Mothers in the postpartum period (over a period of 6 weeks to 6 months following
delivery)
2) Age less than or equal to 49 years
3)Both primigravida and multigravida mothers.
4)All postpartum mothers in the postpartum period who lived in the area for more than 6
months.
5)Who gave informed consent |
|
| ExclusionCriteria |
| Details |
1)Women with a history of psychiatric disorders or those currently undergoing any
psychiatric treatment.
2)Critically ill mothers who are unable to respond.
3)Mothers who have experienced stillbirth or neonatal death. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EPDS Score more than 12 Postpartum Depression |
6 weeks,1 month, 2 month, 3 month,4 month,5 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The proposed PhD thesis titled "Postpartum Depression (PPD) Among Urban and Rural Mothers in Pune, Maharashtra: A Comparative Analytical Study" aims to investigate the prevalence, determinants, and impact of postpartum depression among mothers from urban and rural settings. The study adopts a comparative approach to identify disparities in mental health outcomes, healthcare access, and socio-cultural influences on maternal mental health in these populations. The research involves a mixed-methods methodology, including quantitative surveys and qualitative interviews, to gather comprehensive insights. Key objectives include assessing the prevalence of PPD, identifying risk factors specific to each demographic, and evaluating the effectiveness of existing healthcare interventions in addressing postpartum mental health. By highlighting the differences and similarities between urban and rural mothers, this study seeks to provide evidence-based recommendations for targeted public health strategies and policy interventions to improve maternal mental health care in Pune and similar socio-cultural contexts. |