| 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
|
|
|
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
|
|
|
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. |