Impact of Early Versus Delayed Cord Clamping on Oxidative Stress in Neonates With Intrauterine Growth Restriction: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Antioxidant Status (TAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 0 Hours 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Early Umbilical Cord Clamping (ECC) (Procedure)
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.
干预措施: Delayed Umbilical Cord Clamping (DCC) (Procedure)
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.
干预措施: Delayed Umbilical Cord Clamping (DCC) (Procedure)
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.
干预措施: Early Umbilical Cord Clamping (ECC) (Procedure)
结局指标
主要结局
Total Antioxidant Status (TAS)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Ozge Baykan Copuroglu
Asst. Prof.
Istanbul Arel University