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CTRI Number  CTRI/2025/05/087686 [Registered on: 27/05/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of delayed cord clamping in neonates born to mothers with comorbidities  
Scientific Title of Study   Effect of delayed cord clamping in neonates born to mothers with comorbidities - A Randomised Controlled Trial study 
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 saipavankumar M 
Designation  DM neonatology resident 
Affiliation  MOSC medical college  
Address  Department of neonatology MOSC medical college kolenchery Ernakulam district kerala

Ernakulam
KERALA
682310
India 
Phone  8848142055  
Fax    
Email  tresspavan8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANU RAJAN IDICULA 
Designation  Assistant Professor 
Affiliation  MOSC medical college 
Address  Department of neonatology MOSC medical college kolenchery Ernakulam district kerala

Ernakulam
KERALA
682310
India 
Phone  8547728675  
Fax    
Email  manurq@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANU RAJAN IDICULA 
Designation  Assistant Professor 
Affiliation  MOSC medical college 
Address  Department of neonatology MOSC medical college kolenchery Ernakulam district kerala

Ernakulam
KERALA
682310
India 
Phone  8547728675  
Fax    
Email  manurq@gmail.com  
 
Source of Monetary or Material Support  
MOSC Medical College Kolenchery Ernakulam Dist. Kerala Pincode - 682311 
 
Primary Sponsor  
Name  Dr MANU RAJAN IDICULA  
Address  Assistant professor Department of Neonatology MOSC Medical College Kolenchery Ernakulam-682311 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saipavankumar M  MOSC Medical College  Department of Neonatology MOSC Medical College Kolenchery Ernakulam-682310
Ernakulam
KERALA 
8848142055

tresspavan8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Delayed cord clamping  delayed cord clamping for 30-60 seconds 
Comparator Agent  delayed cord clamping  delayed cord clamping more than 60 seconds 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Inborn singleton neonates from Gestational age 34 weeks to 42 weeks born to mothers with comorbidities (Like Hypertension, Diabetic Mellitus, Hypothyroidism, Anaemia as diagnosed by the obstetrician.)  
 
ExclusionCriteria 
Details  1. Outborn neonates
2. Neonates requiring resuscitation
3. Not obtaining parental consent
4. Neonates born to mother with hemodynamic instability, placenta previa or abruption placentae and multiple gestations
5. Neonates with major congenital malformations and fetal hydrops.  
 
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 
Hematocrit at time of cord clamping and within 24 hours of life  birth to 24 hours of life
 
 
Secondary Outcome  
Outcome  TimePoints 
1)Transcutaneous bilirubin at 24 hours of life
2)Incidence of neonatal Hyperbilirubinemia
3)Incidence of Hypoglycemia
4)Requirement & duration of phototherapy
5)Readmission for hyperbilirubinemia
 
Birth to 7 days of life 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   07/06/2025 
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  

Delayed cord clamping (DCC) is a practice endorsed by multiple international organizations for its benefits in improving neonatal hematologic status and iron stores. However, most existing literature is focused on low-risk deliveries, with limited data on its applicability and safety in neonates born to mothers with comorbidities such as hypertension, diabetes mellitus, hypothyroidism, and anemia. These conditions are common in pregnancy and potentially alter fetal physiology and placental perfusion, thereby influencing the outcomes of placental transfusion.

This randomized controlled trial aims to evaluate the clinical and hematological effects of two different timings of DCC between 30 to 60 seconds versus more than 60 seconds on neonates born at more than 34 weeks of gestation to mothers with predefined comorbidities. Primary outcomes include neonatal hematocrit ,incidence of polycythemia, assess hyperbilirubinemia, phototherapy requirements, hypoglycemia, and persistent tachypnea. The results will help inform evidence-based guidelines for optimal cord clamping timing in this high-risk population.

 
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