Intrauterine Growth Restriction and Intrauterine Fetal Death

Istanbul Arel University

Status: Completed

Conditions: Umbilical Cord Clamping Time; Intrauterine Growth Restriction (IUGR); Oxidative Stress in Neonates

Treatments: Procedure: Early Umbilical Cord Clamping (ECC); Procedure: Delayed Umbilical Cord Clamping (DCC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07031583

KayseriCityHospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: Under 1 hour old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 4 patient groups

IUGR-Delayed Cord Clamping (IUGR-DCC)

Experimental group

Description:

Neonates diagnosed with intrauterine growth restriction (IUGR) received delayed umbilical cord clamping, performed 60-180 seconds after birth. Umbilical cord blood samples were collected immediately for oxidative stress analysis.

Treatment:

Procedure: Delayed Umbilical Cord Clamping (DCC)

IUGR - Early Cord Clamping (IUGR-ECC)

Active Comparator group

Description:

Neonates with IUGR underwent early umbilical cord clamping, within 60 seconds after birth. Umbilical cord blood samples were collected for comparison with delayed clamping groups.

Treatment:

Procedure: Early Umbilical Cord Clamping (ECC)

AGA - Delayed Cord Clamping (AGA-DCC)

Experimental group

Description:

Neonates appropriate for gestational age (AGA) underwent delayed cord clamping, performed 60-180 seconds after birth. Biochemical markers of oxidative stress were measured using cord blood samples.

Treatment:

Procedure: Delayed Umbilical Cord Clamping (DCC)

AGA - Early Cord Clamping (AGA-ECC)

Active Comparator group

Description:

AGA neonates received early umbilical cord clamping, within the first 60 seconds post-delivery. Cord blood was analyzed for oxidative stress markers as a baseline comparator.

Treatment:

Procedure: Early Umbilical Cord Clamping (ECC)