Intrauterine Growth Restriction and Intrauterine Fetal Death

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2025-06-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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IUGR-Delayed Cord Clamping (IUGR-DCC)

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.

Group Type EXPERIMENTAL

Delayed Umbilical Cord Clamping (DCC)

Intervention Type 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.

IUGR - Early Cord Clamping (IUGR-ECC)

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.

Group Type ACTIVE_COMPARATOR

Early Umbilical Cord Clamping (ECC)

Intervention Type 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 - Delayed Cord Clamping (AGA-DCC)

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.

Group Type EXPERIMENTAL

Delayed Umbilical Cord Clamping (DCC)

Intervention Type 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 - Early Cord Clamping (AGA-ECC)

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.

Group Type ACTIVE_COMPARATOR

Early Umbilical Cord Clamping (ECC)

Intervention Type 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.

Interventions

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Delayed 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.

Intervention Type PROCEDURE

Early 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes