| 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
|
|
|
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
|
|
|
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. |