| CTRI Number |
CTRI/2026/03/105852 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Umbilical cord milking and Delayed cord clamping on Blood parameters in newborn |
|
Scientific Title of Study
|
Effect of Umbilical cord Milking vs Delayed cord clamping on venous Hematocrit at 72 hours of life in late preterm and term neonates: 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 |
Gokulnath R |
| Designation |
Junior Resident |
| Affiliation |
Sri Venkateshwaraa medical college and hospital |
| Address |
Department of Paediatrics
Sri Venkateshwaraa medical college and hospital, Ariyur, Pondicherry 605102
13- A Pondy villupuram main road, Ariyur, Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9944332682 |
| Fax |
|
| Email |
gokulnath2608@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gayathri |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa medical college and hospital |
| Address |
Department of Paediatrics
Sri Venkateshwaraa medical college and hospital, Ariyur, Pondicherry 605102
13- A Pondy villupuram main road, Ariyur, Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9894686607 |
| Fax |
|
| Email |
pradhapkrish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gokulnath R |
| Designation |
Junior Resident |
| Affiliation |
Sri Venkateshwaraa medical college and hospital |
| Address |
Department of Paediatrics
Sri Venkateshwaraa medical college and hospital, Ariyur, Pondicherry 605102
13- A Pondy villupuram main road, Ariyur, Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9944332682 |
| Fax |
|
| Email |
gokulnath2608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa medical college and hospital |
| Address |
13-A, Pondy Villupuram main road, Ariyur, Pondicherry 605102 |
| 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 Gokulnath R |
Sri Venkateshwaraa medical college and hospital, |
Department of Paediatrics, Sri Venkateshwaraa medical college and hospital,
13- A Pondy villupuram main road, Ariyur, Pondicherry 605102
Pondicherry
PONDICHERRY |
9944332682
gokulnath2608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Ethics Commitee - Sri Venkateshwaraa medical college and medical hospital |
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 |
Delayed cord clamping immediately after birth |
| Intervention |
Umbilical cord Milking |
Intact Umbilical cord milking immediately after birth |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
1) All Late preterm & Term babies.
2) Singleton pregnancy
3) Babies vigorous at birth
|
|
| ExclusionCriteria |
|
|
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 effect of umbilical cord milking VS delayed cord clamping on venous hematocrit |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of polycythemia between Umbilical Cord Milking & Delayed Cord Clamping.
To compare the incidence of hyperbilirubinemia between Umbilical Cord Milking & Delayed Cord Clamping
|
72 hours |
|
|
Target Sample Size
|
Total Sample Size="184"
Sample Size from India="184"
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)
|
10/03/2026 |
| 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 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 open-label randomized controlled trial conducted at SVMCH & RC to evaluate and compare the hematological effects of umbilical cord milking and Delayed cord clamping in late preterm & term neonates. All included mothers will be counseled regarding the potential benefits of placental transfusion and informed about the study procedures. Written informed consent will be obtained from mothers prior to enrollment. Participants will be randomised in a 1:1 ratio for either groups. Delayed cord clamping - Umbilical cord clamped at least 120 seconds from the time of delivery. Umbilical cord milking- The intact umbilical cord for its remaining accessible length (nearly half of the total length) was milked four times between thumb and forefinger towards the baby’s abdomen.
|