NCT07385326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 27, 2026

Last Update Submit

January 27, 2026

Conditions

Preterm BirthUmbilical Cord Clamping

Keywords

Preterm newbornUmbilical cord clampingHematopoietic stem cellsPeripheral bloodRandomized study

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Immediate Cord ClampingPROCEDURE

Clamping of the umbilical cord within 30 seconds after delivery.

Immediate Cord Clamping (ICC)
Delayed Cord ClampingPROCEDURE

Clamping of the umbilical cord 60 seconds after delivery.

Delayed Cord Clamping (DCC)
Umbilical Cord MilkingPROCEDURE

Milking of a 20 cm segment of the umbilical cord toward the infant before clamping.

Umbilical Cord Milking (UCM)

Eligibility Criteria

Age0 Days+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Meryem Ceyhan, Dr.

    Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Outcome assessors were blinded to group allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to three parallel groups based on umbilical cord management method.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)