| CTRI Number |
CTRI/2024/07/070602 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to assess production of breastmilk and breastfeeding practices among mothers admitted at tertiary care center of western Rajasthan after application of lactation promotion bundle |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of lactation promotion bundle on production of breastmilk and breastfeeding practices among mothers admitted at tertiary care center of western Rajasthan |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnika Negi |
| Designation |
PG student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
| Address |
Department-College of Nursing AIIMS, Basni Phase2, Jodhpur, Rajasthan 342005
Department- College of Nursing, AIIMS, Basni Phase2, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7895245775 |
| Fax |
|
| Email |
swarnikanegi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh chandra sharma |
| Designation |
Associate Professor |
| Affiliation |
AII India Institute of Medical Sciences , jodhpur, Rajasthan |
| Address |
Department-College of Nursing, AIIMS, Room no. 2, Basni Phase 2, Jodhpur, Rajasthan 342005
Department-College of Nursing, AIIMS, Room no.2, Basni Phase 2, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh chandra sharma |
| Designation |
Associate Professor |
| Affiliation |
AII India Institute of Medical Sciences , jodhpur, Rajasthan |
| Address |
Department-College of Nursing, AIIMS, Room no. 2, Basni Phase 2, Jodhpur, Rajasthan 342005
Department-College of Nursing, AIIMS, Room no. 2, Basni Phase 2, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09779534307 |
| Fax |
|
| Email |
sharmamukeshchandra0704@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
Swarnika negi |
| Address |
College of Nursing, AIIMS, Jodhpur, Rajasthan 342005 |
| 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 |
| Dr Mukesh chandra sharma |
AIIMS, Jodhpur |
Department-obstetrics & gynaecology
Labour room and Postnatal ward (2B), AIIMS, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN |
9779534307
sharmamukeshchandra0704@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee, All India Institute of Medical Sciences, Jodhpur |
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 |
Lactation Promotion Bundle |
Control group participants will receive the standard routine care that is delivered to all post-natal mothers and their newborn. Experimental group participants will receive intervention along with standard routine care. First control group is enrolled in the study. On day 1st, 2nd and 3rd, observation of volume of breastmilk production and breastfeeding practices among post-natal mothers in the control group will be done and in between each observation routine care will be provided.
After collecting data from the control group experimental group will be enrolled in the study. After asking for voluntary participation in the study, consent will be obtained from the subjects, and data related to personal variables will be collected.
On day 1st observation of volume of breastmilk production and breastfeeding practices among postnatal mothers will be done prior to administration of Lactation Promotion Bundle. Further LPB will be administered as per the intervention protocol
On day 2nd and 3rd, observation of volume of breastmilk production and breastfeeding practices among post-natal mothers will be carried out in experimental group and before each observation, intervention in the form of lactation promotion bundle will be repeated by mothers, for which checklist will be provided.
Intervention includes-
1.Breastfeeding counselling which include education about positioning of mother and baby, breastfeeding position, latching and attachment of baby to breast.
2.Breastmassage- Demonstration of breastmassage will be shown to them which they will follow 5 min on each breast, 10min prior to breastfeeding.
3. Relaxation therapy (15-20min per day) demonstration will be given first by researcher. Relaxation therapy include breathing exercise (Anulom vilom, Box breathing, Bhramari pranayama) and meditation music which they will listen.
4.Skin to skin contact-demonstration will be given on day 1 with the help of video and mother will perform twice a day. |
| Comparator Agent |
Routine care |
For control group routine standard care that is given which includes education regarding breastfeeding and breastmassage and use of breastpump duration of this is 3 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a)Healthy new-born more than 35 weeks gestation delivered vaginally both with and without an episiotomy
b)Spontaneous cry immediately after birth
c)Mothers with low milk production who are not able to breastfeed their new-born
d)Mothers who are willing to participate in the study
e)Day 1st of delivery |
|
| ExclusionCriteria |
| Details |
a)New-born requiring initial resuscitation
b)New-born admitted to NICU
c)New-born with congenital malformation
d)Mother producing enough breastmilk secretion
e)Mothers with active herpes simplex lesions on the breast
f)Mother taking Anti-tuberculosis medication
g)Mother with HIV infection, COVID-19 infection
h)Mother on chemotherapy or recent use of radioactive agent
i)Mothers with other co-morbidities in which breastfeeding is contraindicated |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
breastmilk volume
breastfeeding practices of mothers |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
02/09/2024 |
| 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 - NO
|
|
Brief Summary
|
One of the wisest investments any government can make to improve population health is to encourage breastfeeding. There is a low rate of breastfeeding in Rajasthan for a variety of reasons, including low maternal awareness, mental health, and education. A delay in lactation initiation, postpartum stress might result in lower breastmilk and non-exclusive breastfeeding. For breastfeeding to be successful mothers need support, education, and relief from anxiety and stress. The study aims to determine the effect of lactation promotion bundle on production of breastmilk and breastfeeding practices among mothers. The population of interest for this study is post-natal mothers and their new-born. Preparation and validation of an evidence-based Lactation Promotion Bundle will be done. Mothers will be screened for inclusion criteria by interview method. First control group samples will be taken. After asking for voluntary participation in the study, consent will be obtained from subjects in the control group and data related to personal variables will be collected. On day 1st, 2nd , and 3rd, observation of volume of breastmilk production and breastfeeding practices among post-natal mothers in the control group will be done and in between each observation routine care will be provided. After collecting data from the control group experimental group will be enrolled in the study. After asking for voluntarily participation in the study, consent will be obtained from the subjects and data related to personal variables will be collected. On day 1st observation of volume of breastmilk production and breastfeeding practices among postnatal mothers will be done prior to administration of Lactation Promotion Bundle. Further LPB will be administered as per the intervention protocol. On days 2nd and 3rd, observation of volume of breastmilk production and breastfeeding practices among post-natal mothers will be carried out in experimental group, and before each observation, intervention in the form of lactation promotion bundle will be repeated by mothers, for which checklist will be provided.Data will be collected through face to face interview and observation using Bristol breastfeeding assessment tool and breastpump. The outcome of the study will provide valuable insight into the effectiveness of lactation promotion bundle in improving breastmilk and breastfeeding practices among mothers. INTERVENTION 1. Breastfeeding counselling - which include education on breastfeeding techniques like the positioning of mother and baby, breastfeeding positions, latching and attachment of baby to breast. 2. Breastmassage - which include demonstration of breastmassage which mothers will follow for 5 min on each breast, 10min prior to breastfeeding. 3.Relaxation therapy - for 15-20min include Breathing exercises (Anulom vilom, Box breathing, Bhramari Pranayama ) and meditation music which they will listen for relaxation. 4.Skin to skin contact- demonstration will be given with the help of video and mothers will perform for 60min twice a day.
|