Intrauterine Growth Restriction and Intrauterine Fetal Death

NCT07031583 | Completed

• 1 other identifier: KayseriCityHospital
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Total Antioxidant Status (TAS)

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

  At birth (within 30 minutes postpartum)

• Total Oxidant Status (TOS)

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

  At birth (within 30 minutes postpartum)

• Oxidative Stress Index (OSI)

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

  At birth (within 30 minutes postpartum)

Secondary Outcomes (3)

• Catalase Enzyme Activity

  At birth (within 30 minutes postpartum)

• 1-Minute and 5-Minute APGAR Scores

  Within 5 minutes after birth

• Birth Weight

  At birth

Study Arms (4)

IUGR-Delayed Cord Clamping (IUGR-DCC)

EXPERIMENTAL

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.

Procedure: Delayed Umbilical Cord Clamping (DCC)

IUGR - Early Cord Clamping (IUGR-ECC)

ACTIVE COMPARATOR

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.

Procedure: Early Umbilical Cord Clamping (ECC)

AGA - Delayed Cord Clamping (AGA-DCC)

EXPERIMENTAL

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.

Procedure: Delayed Umbilical Cord Clamping (DCC)

AGA - Early Cord Clamping (AGA-ECC)

ACTIVE COMPARATOR

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.

Procedure: Early Umbilical Cord Clamping (ECC)

Interventions

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.

AGA - Delayed Cord Clamping (AGA-DCC); IUGR-Delayed Cord Clamping (IUGR-DCC)

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.

AGA - Early Cord Clamping (AGA-ECC); IUGR - Early Cord Clamping (IUGR-ECC)

Eligibility Criteria

• Age: 0 Hours - 1 Hour
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Arel University: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

Related Publications (2)

• Abdel Ghany EA, Alsharany W, Ali AA, Youness ER, Hussein JS. Anti-oxidant profiles and markers of oxidative stress in preterm neonates. Paediatr Int Child Health. 2016 May;36(2):134-40. doi: 10.1179/2046905515Y.0000000017.

  PMID: 25940692 BACKGROUND

• Demir MB, Copuroglu M, Ozdemir A, Kocer D. Impact of early versus delayed cord clamping on oxidative stress in neonates with intrauterine growth restriction: a prospective randomized controlled trial. BMC Pregnancy Childbirth. 2025 Dec 5;25(1):1291. doi: 10.1186/s12884-025-08335-z.

  PMID: 41350641 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

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

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: March 11, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 2, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)