| CTRI Number |
CTRI/2024/11/077056 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Simulation model based breastfeeding training for antenatal mothers |
|
Scientific Title of Study
|
Effect of simulation based breastfeeding training for antenatal mothers in tertiary care hospital- A randomized control trial |
| 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 k |
| Designation |
MD pediatrics postgraduate |
| Affiliation |
Mahatma Gandhi medical college and research institute |
| Address |
Department of pediatrics
Mahatma gandhi medical college
pillayarkuppam,
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8248994472 |
| Fax |
|
| Email |
monicasep16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anandhi C |
| Designation |
Associate professor-department of pediatrics |
| Affiliation |
Mahatma gandhi medical college and research institute |
| Address |
Department of pediatrics,
Mahatma Gandhi medical college, pillayarkuppam
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8640256429 |
| Fax |
|
| Email |
anandhi.chandramohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anandhi C |
| Designation |
Associate professor-department of pediatrics |
| Affiliation |
Mahatma gandhi medical college and research institute |
| Address |
Department of pediatrics, Mahatma Gandhi medical college
Pillayarkuppam
Pondicherry
607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8640256429 |
| Fax |
|
| Email |
anandhi.chandramohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi medical college hospital and research institute
Pillaiarkuppam
Pondicherry
607402 |
|
|
Primary Sponsor
|
| Name |
Monika k |
| Address |
Department of pediatrics
Mahatma Gandhi medical college and research Institute
Pillaiarkuppam
Pondicherry
Phone- 8248994472 |
| Type of Sponsor |
Other [Individual ] |
|
|
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 Monika |
Mahatma Gandhi medical college and research institute |
Department of pediatrics, opd number 21
Pillaiarkuppam
607402
Pondicherry
Pondicherry
PONDICHERRY |
8248994472
monicasep16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi medical college and research institute Institutional Human Ethics Committee |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Picture based training |
Traditional picture based training – about positioning, attachment and technique of breastfeeding |
| Intervention |
Simulation based training |
Lactation Simulation model and baby
model about positioning, attachment and technique of breastfeeding |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primi antenatal mothers from 34 weeks who are not in labour attending department of obstetrics and gynecology at Mahatma Gandhi Medical College |
|
| ExclusionCriteria |
| Details |
1. Mothers with multiple pregnancy.
2. Mothers with high risk pregnancy.
3. Mothers who have attended any breastfeeding training module prior to the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LATCH Breastfeeding Diagnostic and Assessment Scale |
At 24 and 48hrs after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Breastfeeding Self-Efficacy Scale-Short Form
2. Time of initiation of breast feeding.
3. Effectiveness of expression of breastfeeding in NICU admitted child. |
After delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
27/11/2024 |
| 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
|
Primi antenatal mothers from 34 weeks who are not in labour are identified.Antenatal mothers enrolled into the study will be allotted to either of the group based on the block randomization method.
In interventional group- Lactation Simulation model and baby model about positioning, attachment and technique of breastfeeding
In control group- Traditional picture based training – about positioning, attachment and technique of breastfeeding.
After delivery comparison of both groups done by 1.Initiation Breastfeeding % 2.Latch Score In 24 And 48 Hours. 3.Breastfeeding Self Efficacy Scale |