| CTRI Number |
CTRI/2024/10/075744 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Peer support intervention for successful breastfeeding. |
|
Scientific Title of Study
|
Effectiveness of peer to peer breastfeeding support groups compared to individual lactation consultations for supporting breastfeeding after birth among primi mothers admitted at postnatal wards at selected tertiary care hospitals at Belagavi Karnataka |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janice Dorothy Furtado |
| Designation |
MSc 2nd year student |
| Affiliation |
Department of OBG nursing KAHER Institute of Nursing Sciences Belagavi |
| Address |
Department of OBG nursing KAHER Institute of Nursing Sciences Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9284010510 |
| Fax |
|
| Email |
furtadojandorothy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Dandagi |
| Designation |
Senior Tutor and Guide |
| Affiliation |
Department of OBG nursing KAHER Institute of Nursing Sciences Belagavi |
| Address |
Department of OBG nursing KAHER Institute of Nursing Sciences Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8904669742 |
| Fax |
|
| Email |
shwetadandagi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Dandagi |
| Designation |
Senior Tutor and Guide |
| Affiliation |
Department of OBG nursing KAHER Institute of Nursing Sciences Belagavi |
| Address |
Department of OBG nursing KAHER Institute of Nursing Sciences Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8904669742 |
| Fax |
|
| Email |
shwetadandagi22@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Nursing Sciences Belagavi Karnataka India 590010 |
| KLE Dr Prabhakar Kore Hospital and Medical Research Centre Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Janice Dorothy Furtado |
| Address |
KAHER Institute of Nursing Sciences Nehru Nagar Belagavi Karnataka India 590010 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Janice Furtado |
KLE Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of OBG nursing Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA |
9284010510
furtadojandorothy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE University Belgaum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individual Lactation consultations |
Lactation consultations
Lactation consultations refers to training by the investigator which offers postnatal mothers with expert lactation care and assistance during the postnatal period and the training includes importance of breastmilk and its contents and correct position and correct latching and problems of breastfeeding and how to overcome them |
| Intervention |
Peer to peer breastfeeding support groups |
Following training from the investigator a postnatal mother establishes a support group of 5 other postnatal mothers who have similar experiences or issues and the group members offer support to one another as well as guidance on breastfeeding counseling to other members of the group
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of preterm or term infants with singleton or multiple births who underwent C section for the first time and admitted at postnatal wards at Dr Prabhakar Kore Hospital and Medical Research Centre Belagavi and Mothers who are willing to participate |
|
| ExclusionCriteria |
| Details |
Mothers who underwent normal vaginal delivery
Mothers of Infants with cleft lip and palate
Mothers whose babies are admitted in NICU
Mothers who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant difference between the mean latch scores of primi postnatal mothers using two different breastfeeding training techniques before and after the intervention |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased breastfeeding initiation and improved breastfeeding during and enhanced maternal confidence |
4 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
01/11/2024 |
| 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="0"
Months="4"
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 an experimental study comparing the effectiveness of peer to peer breastfeeding support groups with individual lactation consultations for supporting breastfeeding after birth among 360 primi mother’s (180 in each group) who underwent C section and admitted at postnatal wards in selected tertiary care hospital at Dr Prabhakar Kore Hospital and MRC Belagavi Karnataka. The primary outcome measures will be that there will be significant difference in post test latch score after the training |