Umbilical Cord Clamping Methods and Stem Cell Counts in P... | NCT07385326

Studies
Umbilical Cord Clamping Methods and Stem Cell Counts in Preterm Infants

NCT07385326

Sponsor

Era Tufan Benli

Status

Completed

Last Update Posted

Feb 4, 2026Actual

Enrollment

49Actual

Phase

Not Applicable

Conditions

Preterm Birth
Umbilical Cord Clamping

Interventions

Immediate Cord Clamping
Delayed Cord Clamping
Umbilical Cord Milking

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jan 27, 2026

First Submission Date that Met QC Criteria

Jan 27, 2026

First Posted Date

Feb 4, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Feb 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Era Tufan Benli, Principal Investigator, Dr. Sami Ulus Children's HospitalSponsor-Investigator

Lead Sponsor

Era Tufan BenliOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.

Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Peripheral blood samples were collected after birth to assess stem cell concentrations.

The aim of the study was to determine whether physiological cord management strategies could influence early hematologic adaptation in preterm infants. The study was conducted using standard clinical procedures without additional intervention beyond routine care.

Detailed Description

This prospective randomized study was conducted to investigate the impact of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.

Eligible preterm infants were randomly allocated to one of the predefined umbilical cord clamping strategies according to the study protocol. All procedures were performed as part of standard obstetric and neonatal care, and no experimental intervention outside routine clinical practice was applied.

Peripheral blood samples were obtained following delivery, and hematopoietic stem cell concentrations were analyzed using standard laboratory methods. The primary outcome was the comparison of stem cell counts between the different cord clamping groups.

The study was initiated and completed in 2015, prior to mandatory prospective clinical trial registration requirements. Ethical approval was obtained from the relevant institutional ethics committee, and informed consent was obtained from parents or legal guardians before participation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Cord Clamping (ICC)	Experimental	Umbilical cord clamped within 30 seconds after birth.	Procedure: Immediate Cord Clamping
Delayed Cord Clamping (DCC)	Experimental	Umbilical cord clamped 60 seconds after birth.	Procedure: Delayed Cord Clamping
Umbilical Cord Milking (UCM)	Experimental	Umbilical cord milked toward the infant before clamping.	Procedure: Umbilical Cord Milking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immediate Cord Clamping	Procedure	Clamping of the umbilical cord within 30 seconds after delivery.	Immediate Cord Clamping (ICC)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neonatal Hemoglobin Level	Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups.	Within first 24 hours after birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm neonates born between 28+0 and 36+6 weeks of gestation.
Infants born at a single tertiary referral center.
Written informed consent obtained from parents prior to delivery.

Exclusion Criteria:

Major fetal congenital anomalies.
Perinatal asphyxia.
Requirement for advanced neonatal resuscitation at birth.
Undetermined gestational age.
Gestational age less than 28 weeks.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meryem Ceyhan, Dr.	Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,		Ankara			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000087526	Umbilical Cord Clamping

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided