| CTRI Number |
CTRI/2024/05/066816 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study and compare the effect of focussed group counselling and routine counselling on Breastfeeding in third-trimester pregnant females can impact their postpartum LATCH scores. |
|
Scientific Title of Study
|
EFFECT OF ANTENATAL FOCUSSED GROUP BREASTFEEDING COUNSELLING VS ROUTINE COUNSELLING IN 3RD TRIMESTER PREGNANT FEMALES ON POSTPARTUM LATCH SCORE. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Gupta |
| Designation |
Post Diploma DNB Trainee |
| Affiliation |
Northern Railway Central Hospital,New Delhi |
| Address |
Room No.47 Department of Pediatrics ,Northern Railway Central Hospital,Basant Lane,New Delhi
New Delhi
DELHI
110055
India |
| Phone |
07309501798 |
| Fax |
|
| Email |
garimagupta099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanushree Joshi |
| Designation |
Senior DMO |
| Affiliation |
Northern Railway Central Hospital ,New Delhi |
| Address |
ROOM NO 47 Department OF Pediatrics ,Northern Railway Central Hospital,Basant Lane,New Delhi
New Delhi
DELHI
110055
India |
| Phone |
09717630540 |
| Fax |
|
| Email |
tannaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanushree Joshi |
| Designation |
Senior DMO |
| Affiliation |
Northern Railway Central Hospital ,New Delhi |
| Address |
Room no 47,Pediatrics Department,Northern Railway Central Hospital,Basant Lane,New Delhi
New Delhi
DELHI
110055
India |
| Phone |
09717630540 |
| Fax |
|
| Email |
tannaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital,Basant Lane,New Delhi |
|
|
Primary Sponsor
|
| Name |
Northern Railway Central Hospital |
| Address |
Northern Railway Central HOSPITAL,BASANT LANE ,New DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Garima Gupta |
Northern Railway Central Hospital |
Obstetrics and Gynaecology Department, Northern Railway Central Hospital,Basant Lane, ,New Delhi
New Delhi
DELHI |
07309501798
garimagupta099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Northern Railway Central Hospital, IEC-NRCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
focussed counselling on
breastfeeding |
Intervention group will be provided a questionnaire to assess their knowledge &
attitude towards the breast feeding followed by focussed counselling on
breastfeeding in sessions conducted in the department for 3 month. |
| Comparator Agent |
Routine counselling on breast feeding |
Non intervention group mothers will be provided with routine counselling on
breastfeeding by the attending obstetrician. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All the 3rd trimester pregnant females who are interested for focused group counselling will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Pregnant females with antenatal scan showing congenital anomalies,Pregnant females with severe medical or surgical illnes,Females with multiple pregnancies,Mothers with who deliver babies before 37 completed weeks of gestation and babies who developed neonatal complications within 24 hours of birth will be excluded from study at the time of assessment of LATCH SCORE,Unbooked cases
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the effect of ante-natal focussed group counselling and routine antenatal counselling on breast feeding, in 3rd trimester pregnant females, on their postpartum LATCH score, in Northern Railway Central Hospital, New Delhi. |
With in 24 hours of delivery of baby. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the breast feeling problems, misconceptions and psychological issues related to
breast feeding in pregnant females in Northern Railway Central Hospital New Delhi. |
within 72 hours |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| 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="6"
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
|
The aim of the study is to compare the effect of ante-natal focussed group counselling and routine antenatal counselling on breast feeding, in 3rd trimester pregnant females. All the 3rd trimester pregnant females aged between 20 to 40 years who are interested for focused group counselling will be enrolled in the study. Pregnant females with antenatal scan showing congenital anomalies, Pregnant females with severe medical or surgical illness, unbooked cases, Females with multiple pregnancies, Mothers with who deliver babies before 37 completed weeks of gestation and babies who developed neonatal complications within 24 hours of birth will be excluded from study at the time of assessment of LATCH SCORE. Sampling will be convenient sampling method ,The average monthly delivery rate in our hospital is around 60 per month and about 10% babies require immediate NICU admission due to prematurity, hypoxia, twin delivery and respiratory distress, which are excluded from the study group , The intervention period for antenatal counselling will be the initial 3 months of the study. So the estimated study population for the study period would be total around 162 mothers. All the pregnant women’s in 3rd trimester in the OBGY department will be enrolled in the study and explained regarding the need and importance of the study. They will be provided with the patient information sheet both in English and Hindi. They will be provided with the patient consent form to ensure the consensual participation in the study. The mothers will be allocated in, intervention and non-intervention group using block randomisation by group no. written over chit in a sealed envelope. The intervention group, will be provided a questionnaire to assess their knowledge & attitude towards the breast feeding followed by focussed counselling on breastfeeding in sessions conducted in the department • The Non-intervention group mothers will be provided with routine counselling on breastfeeding by the attending obstetrician. • The breast-feeding focussed group counselling session will be planned in OPD visit. • A single session will be given to each participant for 1 hour duration in peer groups by the principal investigator. • Counselling session will mainly focus on - • a) proper position of breastfeeding, b) proper latch, c) when to start breastfeeding after delivery, d) ideal duration of each breastfeeding session, e) ideal time interval 14 between two breastfeeding sessions, f) duration of feed on each breast, g) importance of fore milk, h) importance of hind milk, i) benefits of colostrum, j) benefits of breast milk to baby, k) benefits of breastfeeding to themselves, l) benefits of breastfeeding to family, m) benefits of breastfeeding to society. • Additional focus will be given regarding negative hurdles about breastfeeding mothers like myths and misconceptions, operative delivery, cultural taboos, the influence of older women, lack of confidence, maternal worries, period of breastfeeding post delivery etc. • Routine counselling on breast feeding will be provided by the attending obstetrician/ pediatrician during ANC visits. • LATCH SCORE will be calculated with in 24 hour post partum by the principal investigator in the focused counselling group and routine counselling group. |