Skip to main content
OpenTrials
Completed

NCT Number: NCT07031583

Intrauterine Growth Restriction and Intrauterine Fetal Death

This study investigated whether delaying the clamping of the umbilical cord after birth can reduce harmful oxidative stress in newborns, especially in those who did not grow well during pregnancy (intrauterine growth restriction - IUGR). By comparing early and delayed cord clamping in 90 newborns, researchers found that delayed clamping improved antioxidant protection and reduced signs of oxidative damage. These benefits were more significant in babies with IUGR. The results suggest that delaying cord clamping could help support better early health outcomes in vulnerable newborns.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrauterine Growth Restriction (IUGR) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Oxidative Stress in Neonates Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Umbilical Cord Clamping Time Urogenital Diseases

Age range

0 hour–1 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri City Hospital

Kayseri, 38130, Turkey (Türkiye)

About this study

This prospective, randomized clinical study examined the effects of early versus delayed umbilical cord clamping on oxidative stress in newborns, with a specific focus on those diagnosed with intrauterine growth restriction (IUGR). Oxidative stress occurs when the body has an imbalance between harmful molecules (oxidants) and protective defenses (antioxidants), which may negatively affect newborns, especially those who experienced limited growth in the womb.

A total of 90 newborns were included and grouped based on their growth status (IUGR or appropriate for gestational age) and the timing of cord clamping (early: within 60 seconds; delayed: after 60-180 seconds). Blood samples were taken from the umbilical cord immediately after birth to measure markers of oxidative stress and antioxidant activity.

The study found that delayed cord clamping was associated with improved antioxidant levels and reduced oxidative stress, particularly in growth-restricted infants. These findings suggest that delaying cord clamping may provide protective health benefits for high-risk newborns.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Neonates born at ≥29 weeks of gestation
  • Diagnosed with Intrauterine Growth Restriction (IUGR) or classified as Appropriate for Gestational Age (AGA) based on prenatal ultrasonography
  • For IUGR group: estimated fetal weight below the 10th percentile and abnormal umbilical artery Doppler findings (e.g., elevated resistance index, absent or reversed end-diastolic flow)
  • Neonates delivered at Kayseri City Hospital
  • Informed consent obtained from parents or legal guardians

Exclusion criteria

  • Major congenital anomalies or structural malformations
  • Intrauterine infections
  • Preterm birth before 29 weeks of gestation
  • Fetal hydrops
  • Maternal conditions such as preeclampsia, gestational diabetes, or systemic disease
  • Emergency cesarean delivery
  • Neonates requiring immediate postnatal intubation or invasive resuscitation
  • Signs of severe perinatal distress preventing umbilical cord sampling

Treatment and study plan

Delayed Umbilical Cord Clamping (DCC)

Procedure

The umbilical cord was clamped between 60 and 180 seconds after birth or after the cessation of cord pulsation, in accordance with WHO recommendations. This procedure allows for additional placental transfusion and potential enhancement of neonatal antioxidant capacity.

Early Umbilical Cord Clamping (ECC)

Procedure

The umbilical cord was clamped within the first 60 seconds after birth. This represents the standard or traditional approach used for comparison with delayed clamping in terms of oxidative stress outcomes.

Primary outcomes

  1. Total Antioxidant Status (TAS)

    Time frame: At birth (within 30 minutes postpartum)

    TAS levels in umbilical cord blood will be measured using a validated colorimetric method (Erel, 2004). Higher values indicate greater antioxidant capacity.

  2. Total Oxidant Status (TOS)

    Time frame: At birth (within 30 minutes postpartum)

    TOS levels in umbilical cord blood will be assessed using a spectrophotometric assay (Erel, 2005). Elevated levels reflect greater oxidative stress.

  3. Oxidative Stress Index (OSI)

    Time frame: At birth (within 30 minutes postpartum)

    OSI will be calculated as the ratio of TOS to TAS multiplied by 10. It provides a combined indicator of oxidative balance.

Secondary outcomes

  1. Catalase Enzyme Activity

    Time frame: At birth (within 30 minutes postpartum)

    Catalase activity in umbilical cord blood will be measured via spectrophotometry. Catalase is an endogenous antioxidant enzyme that reflects neonatal oxidative defense capacity.

  2. 1-Minute and 5-Minute APGAR Scores

    Time frame: Within 5 minutes after birth

    Clinical scoring system evaluating neonatal adaptation at 1 and 5 minutes of life (heart rate, respiration, muscle tone, reflex, color). Higher scores indicate better clinical condition.

  3. Birth Weight

    Time frame: At birth

    Neonatal birth weight (in grams) will be recorded and compared across groups to evaluate any association with clamping time and oxidative status.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Kayseri City Hospital

Registry information

Official study title

Impact of Early Versus Delayed Cord Clamping on Oxidative Stress in Neonates With Intrauterine Growth Restriction: A Prospective Comparative Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.