| CTRI Number |
CTRI/2024/05/068143 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the efficacy of immediate vs early skin to contact on initiation of breast feeding, newborn temperature and duration of third stage of labour |
|
Scientific Title of Study
|
Effect of immediate vs early skin to skin contact of mother and newborn on initiation of breast feeding,newborn temperature and duration of third stage of labor A randomized control 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 |
Badveli sai harsha |
| Designation |
Post graduate |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no: 99, paediatrics opd, Sri Manakula Vinayagar Medical College and Hospital , Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7386696632 |
| Fax |
|
| Email |
saiharshabadveli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARUL KUMARAN A |
| Designation |
PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO:99, PAEDIATRICS OPD, SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL, PUDUCHERRY
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9789722422 |
| Fax |
|
| Email |
arulkumaran76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Badveli sai harsha |
| Designation |
Post graduate |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no : 99, Paediatrics opd, Sri Manakula Vinayagar Medical College and Hospital , Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7386696632 |
| Fax |
|
| Email |
saiharshabadveli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical College and hospital , Pondicherry, 605107,India |
|
|
Primary Sponsor
|
| Name |
BADVELI SAI HARSHA |
| Address |
Room no 99, Paediatrics opd, department of paediatrics, sri manakula vinayagar medical college and hospital ,kalitheerthalkuppam, madagadipet,puducherry-605107 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 SAI HARSHA |
Sri manakula vinayagar medical college and hospital |
Room number 99, paediatrics opd, Department of paediatrics, kalitheerthalkuppam, madagadipet, puducherry, 605107
Pondicherry
PONDICHERRY |
7386696632
saiharshabadveli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH -ETHICS COMMITTEE |
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 |
| Comparator Agent |
Early skin to skin soon after the birth |
Early skin to skin contact for 30 minutes soon after initial steps of resuscitation
|
| Intervention |
Immediate skin to skin contact |
Immediate skin to skin contact for 30 minutes after birth |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Term newborns born by normal vaginal delivery
|
|
| ExclusionCriteria |
| Details |
Preterm, SGA babies
Babies born by LSCS
Mothers with perinatal complications and newborns with congenital malformations with with indication for separation of the mother and newborn at the time of birth will nor be included
Mothers who are nor willing to be a part the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To initiate breastfeeding soon after the birth and preventing hypothermia in the newborn |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the duration of third stage of labour |
30minutes |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
10/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 randomized controlled double blinded study will be conducted in the Department of Paediatrics, Sri manakula vinayagar medical college and hospital (SMVMCH) a teritiary care hospital in puducherry after the approval of Research Committee and Institutional Ethics Committee. Newborns who fulfill the criteria will be included in the study after the informed and written consent which is being obtained during antenatal checkups or from the father/blood relative prior to the delivery. Sequentially numbered sealed opaque envelope will be opened by Post graduate or Intern and the intervention which is written in the card will be administered. Baseline sociodemographic details will be recorded in proforma. After explaining the procedure and obtaining the consent, Newborns in the immediate skin to skin contact (Group A) will be placed on the mothers bare chest in a prone position immediately after birth even before placental delivery and episiotomy after which the Apgar score was determined and the newborn was dried and covered with prewarmed blanket . Newborns in the early skin to skin contact (Group B) were wrapped in sterile towels and placed under a warmer and then dried. The Apgar score will be calculated soon after the clamping of umbilical cord , after which newborn were weighed and then handed to the mother to initiate breast feeding. A principal investigator blinded to interventions will assess successful of breastfeeding using LATCH score, duration of third stage of labor, and newborn temperature. |