| CTRI Number |
CTRI/2024/07/070278 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| 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 delayed cord clamping and umbilical cord milking in newborn on hemoglobin,biochemical and other clinical parameters |
|
Scientific Title of Study
|
Comparison of delayed cord clamping and umbilical cord milking in term infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
THAMIZHARASAN G |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO.49,PEDIATRIC OPD,
DEPARTMENT OF PEDIATRICS,
Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8608125664 |
| Fax |
|
| Email |
dr.thamizharasan36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHARATH KUMAR T |
| Designation |
PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO.49,PEDIATRIC OPD,
DEPARTMENT OF PEDIATRICS,
Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBHARATH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO.49,PEDIATRIC OPD,
DEPARTMENT OF PEDIATRICS,
Sri Manakula vinayagar medical college and hospital, kalitheerthalkuppam,Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9003468873 |
| Fax |
|
| Email |
scooby_25575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital, Puducherry,605107,india |
|
|
Primary Sponsor
|
| Name |
THAMIZHARASAN G |
| Address |
Room no.49,Paediatrics OPD, Department of paediatrics,
Sri manakula vinayagar medical college and hospital,
Kalitheerthalkuppam,
Madagadipet,Puducherry-605107, india |
| 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 |
| DrThamizharasan |
Sri manakula vinayagar medical college and hospital |
Room no-49 pediatric opd, department of pediatrics,sri manakula vinayagar medical college and hospital kalitheerthalkuppam,
Madagadipet
Pondicherry
Pin-605107
Pondicherry
PONDICHERRY |
7904484075
dr.thamizharasan36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTE |
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 |
Delayed cord clamping |
To compare the level of hemoglobin ,serum bilirubin levels in newborns after delayed cord clamping for 30-60seconds |
| Intervention |
Umbilical cord milking |
To compare the level of hemoglobin ,bilirubin levels in newborns after umbilical cord milking |
|
|
Inclusion Criteria
|
| Age From |
9.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Female |
| Details |
Gestational age ≥ 37weeks
Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Birth asphyxia
Preterm infants
Twin gestation
Placental insuffiencies
Placenta praevia
Abruption placenta
Non vigorous babies
Rh negative pregnancy
Congential anomalies on antenatal scan
Downes Score more than or Equal to 1 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the level of Haemoglobin at 72 hours in term infants i.e ≥ 37weeks between Delayed cord clamping and Umbilical cord milking in term infants
|
72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic(HR,RR,SPO2), other haematological(HCT, TSB) & clinical parameters between delayed cord clamping & umbilical cord milking in term infants.
|
At birth & 72 hours of life |
|
|
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)
|
19/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Randomized controlled trial study will be conducted on all term neonates i.e Gestational age ≥ 37weeks delivered either through vaginal delivery or Lower segment caesarean section in labour room and labour ot Upon arrival in the delivery room, equipment check will be done and universal precautions be taken. Team briefing and roles will be discussed. After delivery, the babies born out of normal vaginal delivery will be held below the level of vaginal introitus and those born out of caesarean section will be positioned between mother’s thigh. For Group A: Umbilical cord will be clamped 10cm distance from the umbilical stump at atleast 60seconds which will be counted using stopwatch with help of a staff nurse. For Group B : Milking of the available length of the cord will be done over 4 times towards the baby from the vaginal introitus (in vaginal delivery) or from abdominal incisional site in case of caesarean section will be done and then the cord will be clamped and cut. Immediately following delivery, the process of evaluation, decision and action (resuscitation) begins in following order. Newborn will be placed on warming table, dried, suctioning if necessary and assessment of supplemental oxygen will be done. At birth respiratory distress will be assessed using downes score. Downes score ≥ 2 will be admitted for NICU for further management. At 30minutes heart rate and respiratory rate will be reassessed by auscultation and chest rise movement. All babies will be screened for TFT at 72hours of life and at that time 4ml of venous sample will be collected and hemoglobin, hematocrit and total serum bilirubin levels will be measured. |