| CTRI Number |
CTRI/2020/01/022674 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educating Mothers regarding technique of breastfeeding and assessment of exclusive breastfeeding |
|
Scientific Title of Study
|
Assessment of videobased educational intervention on breastfeeding technique in primigravida mother’s and it’s effect on early infant feeding pattern -Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja G |
| Designation |
Junior Resident Pediatrics |
| Affiliation |
Manipal Academy of higher education |
| Address |
Kasturba Medical college 203,lighthouse hill road Hampankatta Department of Pediatrics,Junior Resident Mangalore Karnataka.
Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7411511507 |
| Fax |
|
| Email |
poojagovind1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Kamath |
| Designation |
Associate Dean and Professor of Pediatrics |
| Affiliation |
Kasturba Medical college Mangalore Manipal Academy of higher education |
| Address |
Dr Nutan Kamath
Associate Dean
Kasturba Medical college
203,lighthouse hill road
Hampankatta Mangalore Karnataka.
Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448147687 |
| Fax |
|
| Email |
nuthan.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Kamath |
| Designation |
Associate Dean and Professor of Pediatrics |
| Affiliation |
Kasturba Medical college Mangalore Manipal Academy of higher education |
| Address |
Dr Nutan Kamath
Associate Dean
Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka.
Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448147687 |
| Fax |
|
| Email |
nuthan.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Ladygoschen hospital affliliated to Kasturba Medical College Mangalore |
|
|
Primary Sponsor
|
| Name |
Pooja |
| Address |
Dr Pooja Pediatric Resident
203 Lighthouse hill road Hampankatta,Mangalore Kasturba Medical college Mangaluru |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Medical Superindent |
Dr Pooja Lady Goschen Hospital |
Department of Pediatrics and Antenatal wards in Department of Obstetrics and Gynecology 1st floor.Mangalore 575001
Dakshina Kannada
KARNATAKA |
9448869629
poojagovind1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Kasturba medical college,Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IEC Education regarding breastfeeding |
IEC education and flipcharts provided by Govt of karanataka |
| Intervention |
Videobased Educational Intervention about breastfeeding technique and its effect on early infant feeding pattern both in study and IEC education for control group |
Educational video of 2min 20sec duration in kannada language regarding technique of breastfeeding global health media project video |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1)Primigravida Mothers above 18years of age,with no high risk factors(Pre-eclampsia and eclampsia,uncontrolled sugar with hba1c>6.5%,uncompensated cardiovascular disease with NYHA Grade3 and above)admiited for safe confinement and not in labour
2)Literate in Kannada. |
|
| ExclusionCriteria |
| Details |
1)Multiple Pregnancy
2)Mothers not willing exclusively to breastfeed their infants for 6 months.
3)Infants with Orofacial Malformations(cleftlip,cleftlip)
4)Mothers who are not able to breastfeed with in 48hours of delivery(Infants admitted in Nicu and MOthers admitted in Intensive care unit.)
5)Mothers previously educated with video on breastfeeding technique
6)Primary Lactation failure |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of antenatal video education intervention on breastfeeding technique and re-enforcement in early puerperium in primigravida mothers on exclusive breastfeeding rate shortterm at 2 months and longterm at 6 months |
Effect of antenatal video education intervention on breastfeeding technique and re-enforcement in early puerperium in primigravida mothers on exclusive breastfeeding rate shortterm at 2 months and longterm at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Followup telephone survey at 2,4 and 6 months after delivery ,to assess the infant feeding practices (EBF,PBF and CBF) |
2,4 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
07/11/2019 |
| 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="3"
Months="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a video based intervention educating mothers regarding technique of breastfeeding and assessing infant feeding pattern telephonically at 2,4 and 6 months. |