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Completed

NCT Number: NCT07385326

Umbilical Cord Clamping Methods and Stem Cell Counts in Preterm Infants

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.

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Key information

Age range

0 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate Cord Clamping

Procedure

Clamping of the umbilical cord within 30 seconds after delivery.

Delayed Cord Clamping

Procedure

Clamping of the umbilical cord 60 seconds after delivery.

Umbilical Cord Milking

Procedure

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

Primary outcomes

  1. Neonatal Hemoglobin Level

    Time frame: Within first 24 hours after birth

    Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups.

Sponsors and collaborators

Lead sponsor

Era Tufan Benli

Other

Registry information

Official study title

Effect of Umbilical Cord Clamping Method on Peripheral Blood Stem Cell Counts in Preterm Newborns: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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