Skip to content

Intrauterine Growth Restriction and Intrauterine Fetal Death

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07031583
Enrollment
90
Registered
2025-06-22
Start date
2025-03-11
Completion date
2025-06-02
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Restriction (IUGR), Oxidative Stress in Neonates, Umbilical Cord Clamping Time

Keywords

Umbilical Cord Clamping, Fetal Growth Restriction, Oxidative Stress, Total Antioxidant Capacity, Total Oxidant Status

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREDelayed Umbilical Cord Clamping (DCC)

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.

PROCEDUREEarly Umbilical Cord Clamping (ECC)

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.

Sponsors

Kayseri City Hospital
CollaboratorOTHER_GOV
Istanbul Arel University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

The laboratory personnel responsible for analyzing the biochemical markers (TAS, TOS, and catalase) were blinded to the group assignments of the neonates. Samples were coded and processed anonymously to ensure objective assessment of oxidative stress parameters. Other study personnel, including those involved in clinical procedures, were not blinded.

Intervention model description

Four-group parallel design based on neonatal growth status and cord clamping timing.

Eligibility

Sex/Gender
ALL
Age
0 Hours to 1 Hours
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total Antioxidant Status (TAS)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.
Total Oxidant Status (TOS)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.
Oxidative Stress Index (OSI)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

MeasureTime frameDescription
Catalase Enzyme ActivityAt 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.
1-Minute and 5-Minute APGAR ScoresWithin 5 minutes after birthClinical 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.
Birth WeightAt birthNeonatal birth weight (in grams) will be recorded and compared across groups to evaluate any association with clamping time and oxidative status.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026