| CTRI Number |
CTRI/2023/07/055414 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of milking with delayed clamping of umbilical cord on Haemoglobin in babies born by Lower segment caesarean section |
|
Scientific Title of Study
|
Effect of Umbilical Cord Management(UCM) Protocol on Hematological Profile of Babies Born Through Lower Segment Caesarean Section (LSCS) At Discharge-An Open Label Randomised Controlled 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 |
Dr Arit Bhakta |
| Designation |
Resident Paediatrics |
| Affiliation |
Command Hospital (EC), Kolkata |
| Address |
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Kolkata
WEST BENGAL
700027
India |
| Phone |
8013878614 |
| Fax |
|
| Email |
arit.mck1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Ramar |
| Designation |
Associate Professor, Paediatrics |
| Affiliation |
Command Hospital (EC), Kolkata |
| Address |
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Kolkata
WEST BENGAL
700027
India |
| Phone |
9566042868 |
| Fax |
|
| Email |
praveen.army@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Ramar |
| Designation |
Associate Professor, Paediatrics |
| Affiliation |
Command Hospital (EC), Kolkata |
| Address |
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Department of Paediatrics,
3rd Floor, Mother and Child Block, Command Hospital (EC), Kolkata-700027
Kolkata
WEST BENGAL
700027
India |
| Phone |
9566042868 |
| Fax |
|
| Email |
praveen.army@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital (Eastern Command), Kolkata |
|
|
Primary Sponsor
|
| Name |
Command Hospital (Eastern Command), Kolkata |
| Address |
Department of Paediatrics, 3rd Floor, Mother and Child Block, Command Hospital (Eastern Command), Kolkata |
| Type of Sponsor |
Government medical college |
|
|
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 Praveen Ramar |
Command Hospital (Eastern Command), Kolkata |
Department of Paediatrics,
3rd Floor, Mother and Child Block.
Kolkata
WEST BENGAL |
9566042868
praveen.army@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, COMMAND HOSPITAL (EC), ALIPORE, KOLKATA-27 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All neonates born at or more than 34 weeks period of gestation through LSCS at Command Hospital (EC) Kolkata during study period |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed Cord Clamping in babies born through LSCS |
Babies randomized to control arm will have cord clamping done at 60 seconds without milking following standard protocol of delayed cord clamping (DCC) as per WHO. All babies will be investigated for Hb and PCV at discharge, sampling will be combined with discharge bilirubin, blood group, G6PD and TSH screening protocol of institute |
| Intervention |
Umbilical Cord Management(UCM) protocol in babies born through LSCS |
Babies born to mothers randomized to intervention arm will be given UCM protocol/ 3 x milking procedure will be carried out from placenta towards baby involving at least 25cm umbilical cord length. Umbilical cord will be clamped after 60 seconds(delayed cord clamping) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
4.00 Month(s) |
| Gender |
Both |
| Details |
All neonates born at >34 weeks periods of gestation through LSCS at Command Hospital (EC) Kolkata during study period. |
|
| ExclusionCriteria |
| Details |
Babies born with:
1. Perinatal Asphyxia
2. Multifoetal pregnancy
3. Babies having congenital anomalies
4. Anticipated fetal anemia,
5. Category III cardiotocography tracing |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of UCM protocol on hematological profile (Hb & Hct) at discharge of all eligible newborn babies delivered by LSCS. |
72 hours of birth/ discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find effect of UCM protocol on:
1. Significant Neonatal Hyperbilirubinemia (Requiring phototherapy)
2. Requirement of fluid resuscitation or inotropes
3. Serum Ferritin at 3-4 months age
4. Mortality
5. Hospital Stay
|
1. at 72 hours of birth/discharge
2. During hospital stay.
3. At 3-4 months age
4. During hospital staye.
5. During hospital stay. |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Study includes consequent eligible mother-infant dyad delivered at LSCS at CHEC, Kolkata. After getting a written informed consent from parents posted for LSCS, mother will be randomized to either of study arms. Babies born to mothers randomized to intervention arm will be given UCM protocol/ 3 x milking procedure will be carried out from placenta towards baby involving at least 25cm umbilical cord length. Umbilical cord will be clamped after 60 seconds. Babies randomized to control arm will have cord clamping done at 60 seconds without milking following standard protocol of delayed cord clamping (DCC) as per WHO. All babies will be investigated for Hb and PCV at 72 hours or discharge (whichever is earlier), sampling will be combined with discharge bilirubin, blood group, G6PD and TSH screening protocol of institute. All babies will be followed up till 16 weeks for secondary outcome measures. |