| CTRI Number |
CTRI/2025/01/079578 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Starting Breasfeeding Early |
|
Scientific Title of Study
|
Succeed Early- Early Initiation of Breastfeeding |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Malapure |
| Designation |
Assistant Professor |
| Affiliation |
Shri B.M.Patil Medical College,Hospital and Research Centre |
| Address |
OPD NO.2, Department of OBG, Shri B.M.Patil Medical College,Hospital and Research Centre,BLDE (Deemed to be University)
Bijapur
KARNATAKA
586101
India |
| Phone |
9113945722 |
| Fax |
|
| Email |
preeti.malapure@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Preeti Malapure |
| Designation |
Assistant Professor |
| Affiliation |
Shri B.M.Patil Medical College,Hospital and Research Centre |
| Address |
OPD NO.2, Department of OBG, Shri B.M.Patil Medical College,Hospital and Research Centre,BLDE (Deemed to be University)
Bijapur
KARNATAKA
586101
India |
| Phone |
9113945722 |
| Fax |
|
| Email |
preeti.malapure@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Malapure |
| Designation |
Assistant Professor |
| Affiliation |
Shri B.M.Patil Medical College,Hospital and Research Centre |
| Address |
OPD NO.2, Department of OBG, Shri B.M.Patil Medical College,Hospital and Research Centre,BLDE (Deemed to be University)
Bijapur
KARNATAKA
586101
India |
| Phone |
9113945722 |
| Fax |
|
| Email |
preeti.malapure@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , BLDE(DU), VIJAYAPURA |
|
|
Primary Sponsor
|
| Name |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE,VIJAYAPURA |
| Address |
SHRI B.M.PATIL MEDICAL COLLEGE,HOSPITAL & RESEARCH CENTRE,BLDE(DEEMED TO BE UNIVERSITY),SOLAPUR ROAD,VIJAYAPURA,KARNATAKA,586101 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| PREETI MALAPURE |
SHRI B M PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
OPD NO.2,DEPARTMENT OF OBG,SHRI B M PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,VIJAYAPURA
Bijapur
KARNATAKA |
9113945722
preeti.malapure@bldedu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE VIJAYAPURA BLDE(DU)/IEC/1138/2024-25 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
BREASTFEEDING MOTHERS |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All postnatal mothers either normal delivery or Caesarean section.
All outside delivered mothers who came for baby sake.
All postnatal cases who came to OPD for follow-up.
|
|
| ExclusionCriteria |
| Details |
Postnatal mothers admitted in ICU |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the timing of initiation of breastfeeding in postnatal mothers |
1 hour, 4 hour, 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To find out the determinants of delayed initiation of breastfeeding among postnatal mothers. |
4 hour,24 hour,48 hour |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
30/01/2025 |
| 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="0"
Months="0"
Days="15" |
|
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
|
Dear Sir/Madam,
Early initiation of breastfeeding (EIBF) is
defined as ‘Provision
of mothers’ breast milk to infants within
the first hour of birth.
This study aims to understand the difficulties mothers face in starting breastfeeding early . |