| CTRI Number |
CTRI/2024/02/063295 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Educational intervention on Knowledge, Attitude and Practices of Breastfeeding Among Pregnant Women |
|
Scientific Title of Study
|
Educational intervention on Knowledge, Attitude and Practices of Breastfeeding Among Primigravida Women in a Tertiary Care Hospital: Three arm parallel randomised controlled 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 |
Vrinda Praveen |
| Designation |
3rd professional MBBS student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore
Light House Hill Road,Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7561892141 |
| Fax |
|
| Email |
vrindapraveenmcp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Kamath |
| Designation |
Professor and Consultant, Department of Paediatrics |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore
Light House Hill Road,Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448147687 |
| Fax |
|
| Email |
nutan.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Kamath |
| Designation |
Professor and Consultant, Department of Paediatrics |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Mangalore
Light House Hill Road,Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448147687 |
| Fax |
|
| Email |
nutan.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Government Lady Goschen Hospital, Maidan Road, Hampankatta, Mangalore- 575001,
Karnataka |
|
|
Primary Sponsor
|
| Name |
Vrinda Praveen |
| Address |
Kasturba Medical College, Lighthouse Hill Road, Mangalore-575001, Karnataka |
| 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 |
| Vrinda Praveen |
Government Lady Goschen Hospital |
AN wards, 1st floor and PN wards, 5th floor
Maidan Road, Hampankatta,
Mangalore- 575001
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7561892141
vrindapraveenmcp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
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 |
| Intervention |
Educational intervention |
The intervention group 1 will be educated regarding breastfeeding with the help of video and flipcharts, before delivery. Mothers in these groups will be educated individually. The education module will be 1:1 and will last for about 25-30mins. |
| Intervention |
Educational intervention |
The intervention group 2 will be educated regarding breastfeeding with the help of video and flipcharts, post delivery. Mothers in these groups will be educated individually. The education module will be 1:1 and will last for about 25-30mins. |
| Comparator Agent |
Standard of care |
The control group receiving standard hospital care (i.e. ongoing hospital program) only. Educational intervention not given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida term scheduled for institutional delivery (women aged 18-50years) |
|
| ExclusionCriteria |
| Details |
Primigravida mothers in premature labour.
Primigravida mothers with multiple pregnancies.
Primigravida mothers posted for caesarean section.
Primigravida mothers who are ni intensive care unit.
Primigravida mothers who did not give consent for the study.
Neonates whose anticipated antenatal weight by fetal ultrasound is less than 2.5kgs
Neonates who are in neonatal intensive care unit post-delivery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the number of primigravida mothers who exclusively breastfed their offspring in first 48 hours after birth |
48hours post-delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
10/03/2024 |
| 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 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
|
This study is a randomized,three arm, parallel group trial to study the impact of educational intervention on knowledge, attitude and practices of breastfeeding among 144 pregnant primigravida women that will be conducted in Lady Goschen Hospital (a teaching hospital of KMC Mangalore,MAHE), India. Using simple random sampling the required number of subjects will be selected in the setting. The study subjects; the primigravida mothers will be divided into 3 groups, viz. the control group (receiving standard hospital care, i.e. ongoing hospital program), the intervention group-1(receiving standard care and will be educated regarding breastfeeding with the help of video and flipcharts class before delivery) and intervention group-2 (receiving standard care and will be educated regarding breastfeeding with the help of video and flipcharts post-delivery) in equal numbers. Mothers in these groups will be educated individually. The education module will be 1:1 and will last for about 25-30mins.Assessment of breastfeeding by mothers 48hours post-delivery will be done with the help of BBAT (Bristol Breastfeeding Assessment Tool), Knowledgeand Attitude questionnaire will be repeated for all the groups.The primary outcome measures will be to assess the number of mothers who have exclusively breastfed their infants in first 48 hours of life. |