| CTRI Number |
CTRI/2024/09/074040 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effect of counseling done in last trimester on mothers expecting their first child about breastfeeding techniques and benefits and checking the outcome by early initiation and exclusive breastfeeding |
|
Scientific Title of Study
|
Effect of antenatal breastfeeding counselling done in 3rd trimester in primigravida mothers on breastfeeding outcomes during one month after delivery at tertiary care teaching hospital: A non - 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 |
Dr Anisha |
| Designation |
DNB 1st year student |
| Affiliation |
Maharaja agrasen medical college, Agroha Hisar |
| Address |
Paediatric department, A block MAMC agroha Hisar
A BLOCK MAMC agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
9729756218 |
| Fax |
|
| Email |
ANISHASAHARAN24@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Maharaja agrasen medical college, Agroha Hisar |
| Address |
Paediatric department, A block MAMC agroha Hisar
A block MAMC agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
7014197954 |
| Fax |
|
| Email |
Drsgodara2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anisha |
| Designation |
DNB 1st year student |
| Affiliation |
Maharaja agrasen medical college, Agroha Hisar |
| Address |
Paediatric department, A block MAMC agroha Hisar
A block MAMC agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
9729756218 |
| Fax |
|
| Email |
ANISHASAHARAN24@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Maharaja agrasen medical college ,Agroha 125047 , Hisar, Haryana India |
|
|
Primary Sponsor
|
| Name |
Dr Anisha |
| Address |
Paediatric department, A block
Maharaja agrasen medical college 125047 Agroha, Hisar ,Haryana |
| 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 |
| Anisha |
Maharaja agrasen medical college |
Paediatric department, A block MAMC agroha Hisar agroha, hisar
Hisar
HARYANA |
9729756218
ANISHASAHARAN24@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC FOR HUMAN RESEARCH, MAMC AGROHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primigravida mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breastfeeding counselling |
Antenatal breastfeeding counselling to be done in 3rd trimester while routine Antenatal visit and follow up will be done on 1st day , 2nd day and 28 days after delivery |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida mothers in their 3rd trimester and who have given consent |
|
| ExclusionCriteria |
| Details |
Multigravida mothers
Mothers delivering IUDs or baby with orofacial deformity
Mothers not given consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Initiation of breastfeeding within 1 hour to 24 hours of delivery and LATCH score within 24 to 48 hrs hours of birth. |
Within 1 hour to 24 hours of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ANISHASAHARAN24@GMAIL.COM].
- For how long will this data be available start date provided 20-06-2024 and end date provided 01-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIl
|
|
Brief Summary
|
Primigravida mothers who are in their 3rd trimester visiting OPD will be enrolled
in the study after taking their written informed consent and will be divided into two groups.
Group 1 will be counselled in a 30-minute session for technique, early initiation and exclusive breastfeeding
benefits using video-based training and demonstration on a dummy of baby and Breast. Group 2 mothers who have not received antenatal counselling will be taken from the post-natal ward by simple random sampling as a control.
Mothers from both groups will be followed for the next 28 days and the resulting data will be compared. |