| CTRI Number |
CTRI/2025/06/088068 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
The latch score in identification and correction of breastfeeding problems- A Prospective interventional study |
|
Scientific Title of Study
|
Latch score in identification and correction of breastfeeding probelms- A prospective interventional 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 |
Monika Redhal |
| Designation |
Junior Resident |
| Affiliation |
Shri BM Patil medical college and Hospital |
| Address |
OBG OPD NO.2 Department of OBG Shri BM patil medical college,and hospital and research centre bangaramma sajjan campus solapur road vijaypura
bijapur
karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
8171841900 |
| Fax |
|
| Email |
monikaboora021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreedevi Kori |
| Designation |
Associate professor |
| Affiliation |
Shri BM Patil medical college and Hospital |
| Address |
OBG OPD NO.2 Department of Obstetrics and gynaecology Shri BM Patil Medical college and hospital and research centre, Vijaypura,
Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9538846839 |
| Fax |
|
| Email |
shreedevi.kori@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Monika Redhal |
| Designation |
Junior Resident |
| Affiliation |
Shri BM Patil medical college and Hospital |
| Address |
OBG OPD NO.2 Department of OBG Shri BM patil medical college,and hospital and research centre bangaramma sajjan campus solapur road vijaypura
bijapur
karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
8171841900 |
| Fax |
|
| Email |
monikaboora021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri BM Patil college and Research hospital, Vijaypura. Karnataka |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil college and research hospital |
| Address |
Department of OBG Shri BM Patil medical college, Hospital and Research Centre bangaramma sajjan campus solapur road
VIJAYPURA
karnataka |
| 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 |
| Monika Boora |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYAPURA |
Department of Obstetrics and gynaecology Shri BM Patil medical College and Hospital and Research centre bangaramma sajjan campus solapur road
bijapur
karnataka
Bijapur
KARNATAKA |
8171841900
monikaboora021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All Primigravida women who had term delivery(37 weeks to 42 weeks) in our Labour room
starting from January 2024 at the Department of Obstetrics & Gynaecology at BLDE
hospital, Shri B.M. Patil Medical College Hospital and Research Centre, Vijayapura ,
Karnataka , India (DEEMED TO BE UNIVERSITY). |
|
| ExclusionCriteria |
| Details |
• Pre term delivery, mother whos baby is in nicu |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify early breastfeeding issues using the latch assessment and to compare latch score at 1 to 2 hours of delivery before intervention & at 24 to 48 hours of
delivery after intervention. |
To identify early breastfeeding problems using the latch assessment and to compare latch score at 1 to 2 hours of delivery before intervention & at 24 to 48 hours of
delivery after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To educate & to encourage women to donate milk to milk bank |
To educate & to encourage women to donate milk to milk bank |
|
|
Target Sample Size
|
Total Sample Size="229"
Sample Size from India="229"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="229" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Breastfeeding is an important journey that every women has to undergo in her post partum
period. Breastfeeding reduces many neonatal and infant morbidity and mortality.To lower
under-5 and infant mortality, breastfeeding is thought to be a significant intervention (1,2).
Despite the fact that nursing is a natural activity, certain mother-child pairs may experience
difficulties, especially in the early postpartum period (3,4)
.
Inadequate feeds from improper nursing techniques can cause significant loss of weight or
hypernatermic dehydration and jaundice and the need for rehospitalisation.(5)
Research indicates earlier breastfeeding initiation and higher rates of breastfeeding solely
for up to six months and longer breastfeeding duration are connected with exclusive
breastfeeding after discharge from the hospital.(6)
. Although we strongly advocate for
institutional deliveries, the first hospital stay gives medical staff an excellent chance to
evaluate breastfeeding, guide mothers in proper breastfeeding practices, and increase their
confidence in nursing before the mother is released from the hospital.
A methodical approach is required to assess the quality of breastfeeding, recognize issues
with the practice, and promptly implement the necessary corrective measures. This study
used the Latch score (7) to assess the prevalence and kind of early concerns about
breastfeeding and to examine how breastfeeding support affected the Latch score |