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CTRI Number  CTRI/2025/12/098753 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   keeping the umbilical cord intact until natural placental delivery and its effect on the neonatal outcomes. 
Scientific Title of Study   Outcomes of Neonates Born at or Above 36 Weeks of Gestation With Physiological Cord Clamping: A Prospective Analytical 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  OISHEE GIRI 
Designation  JUNIOR RESIDENT 
Affiliation  MEDICAL COLLEGE AND HOSPITAL KOLKATA 
Address  Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Kolkata
WEST BENGAL
700073
India 
Phone  9800575959  
Fax    
Email  oisheegiri98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr DINESH MUNIAN 
Designation  Associate Professor, Department of Paediatrics Medical College Kolkata 
Affiliation  MEDICAL COLLEGE AND HOSPITAL KOLKATA 
Address  Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Kolkata
WEST BENGAL
700083
India 
Phone  9163288916  
Fax    
Email  drdineshmunian@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr DINESH MUNIAN 
Designation  Associate Professor, Department of Paediatrics Medical College Kolkata 
Affiliation  MEDICAL COLLEGE AND HOSPITAL KOLKATA 
Address  Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Kolkata
WEST BENGAL
700083
India 
Phone  9163288916  
Fax    
Email  drdineshmunian@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073 
 
Primary Sponsor  
Name  Dr Oishee Giri 
Address  Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073 
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 OISHEE GIRI  MEDICAL COLLEGE AND HOSPITAL KOLKATA  Department of Neonatology, SNCU-NICU Complex, Medical College and Hospital, 88 College Street, Eden Hospital Road, Kolkata-700073
Kolkata
WEST BENGAL 
9800575959

oisheegiri98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE FOR HUMAN RESEARCH MEDICAL COLLEGE, KOLKATA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Babies born at or above 36 weeks of gestation via both normal vaginal delivery and cesarean section 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  All babies born at or above 36weeks of gestation both normal vaginal delivery and cesarean section 
 
ExclusionCriteria 
Details  Babies born below 36 weeks of gestation
Babies born with gross congenital anomalies not compatible with life
Life threatening health condition of the mother where cord needs to be cut immediately for life saving purposes.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart rate and SpO2 from birth till 5mins of life  Heart rate and SpO2 from birth till 5mins of life 
 
Secondary Outcome  
Outcome  TimePoints 
Hemoglobin levels at 72hrs of life.
Incidence of birth asphyxia
Billirubin levels at 72hrs of life
Breastfeeding rates
Average Duration of NICU stay 
72 hours 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   01/01/2026 
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="0"
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  
Physiological intact cord management involves maintaining umbilical circulation until the newborn establishes spontaneous respiration and cardiorespiratory stability or until natural placental expulsion occurs. This practice allows continued placental transfusion and optimizing neonatal transition. Although delayed cord clamping is globally supported, limited data exist from Indian tertiary centers on immediate postnatal outcomes following this practice in late preterm and term neonates. This study aimed to evaluate heart rate and oxygen saturation at 5 minutes of life following physiological intact cord management, with secondary objectives of assessing hemoglobin and bilirubin at 72 hours. Preterm neonates or those with major congenital anomalies were excluded. A prospective observational study enrolled 118 neonates more than equal to 36 weeks gestation (both LSCS and NVD) at a tertiary care teaching hospital. Physiological intact cord management will be performed per standardized protocol. Heart rate and oxygen saturation will be measured at 5 minutes, hemoglobin and bilirubin were assessed at 72 hours. Data will be analyzed using SPSS version 26. Physiological intact cord management demonstrated superior cardiorespiratory and hematological outcomes while reducing the need for phototherapy compared to conventional clamping. Sustained placental transfusion likely supports improved neonatal transition. Physiological intact cord management enhances neonatal cardiorespiratory transition and hematological status without increasing jaundice risk, supporting its inclusion in standard perinatal care.
 
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