| CTRI Number |
CTRI/2025/03/083386 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
satisfaction of mother regarding human milk bank |
|
Scientific Title of Study
|
Assess the satisfaction level of post-natal mothers regarding human milk donation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupali warghane |
| Designation |
Msc Nursing1st year Student |
| Affiliation |
Shrimati Radhikabai Meghe Memorial College of Nursing sawangi meghe wardha |
| Address |
Shrimati Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Shrimati Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07020018549 |
| Fax |
|
| Email |
rupalivinodzade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs shital sakharkar |
| Designation |
Assistant Professor Department of medical surgical nursing |
| Affiliation |
SRMMCON |
| Address |
SRMMCON Sawangi Meghe Wardha
Shrimati Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07020018549 |
| Fax |
|
| Email |
sheetalmude14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs shital sakharkar |
| Designation |
Assistant Professor Department of medical surgical nursing |
| Affiliation |
SRMMCON |
| Address |
SRMMCON sawangi meghe wardha
Shrimati Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
07020018549 |
| Fax |
|
| Email |
sheetalmude14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Megehe Institute of Higher education and research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institue Higher Education and Research |
| Address |
Datta Meghe Institue Higher Education and Research Sawangi Meghe Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 |
| rupali warghane |
shrimati radhikabai meghe memorial college of nursing |
shrimati radhikabai meghe memorial college of nursing sawangi meghe wardha
shrimati radhikabai meghe memorial college of nursing sawangi meghe wardha
Wardha
MAHARASHTRA |
7020018549
rupalivinodzade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| datta meghe institute og higher education and research ,the institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
human milk bank |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Those post-natal mothers who can speak as well as write in Marathi.
Those post-natal mothers who have donated the milk
Those post-natal mothers who are willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
Those post-natal mothers who are health professionals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Human Milk Donation Satisfaction |
Human Milk Donation Satisfaction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not any perticular |
Notapplicable |
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
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)
|
15/04/2025 |
| 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="0"
Months="6"
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
|
This is the study protocol for Assessing the satisfaction level of post-natal mothers regarding human milk donation. |