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临床试验/CTRI/2025/05/087686
CTRI/2025/05/087686尚未招募3 期

Effect of delayed cord clamping in neonates born to mothers with comorbidities - A Randomised Controlled Trial study

Dr MANU RAJAN IDICULA1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年6月7日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
Hematocrit at time of cord clamping and within 24 hours of life

研究概览

简要总结

Delayed cord clamping (DCC) is a practice endorsed by multiple international organizations for its benefits in improving neonatal hematologic status and iron stores. However, most existing literature is focused on low-risk deliveries, with limited data on its applicability and safety in neonates born to mothers with comorbidities such as hypertension, diabetes mellitus, hypothyroidism, and anemia. These conditions are common in pregnancy and potentially alter fetal physiology and placental perfusion, thereby influencing the outcomes of placental transfusion.

This randomized controlled trial aims to evaluate the clinical and hematological effects of two different timings of DCC between 30 to 60 seconds versus more than 60 seconds on neonates born at more than 34 weeks of gestation to mothers with predefined comorbidities. Primary outcomes include neonatal hematocrit ,incidence of polycythemia, assess hyperbilirubinemia, phototherapy requirements, hypoglycemia, and persistent tachypnea. The results will help inform evidence-based guidelines for optimal cord clamping timing in this high-risk population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • Inborn singleton neonates from Gestational age 34 weeks to 42 weeks born to mothers with comorbidities (Like Hypertension, Diabetic Mellitus, Hypothyroidism, Anaemia as diagnosed by the obstetrician.).

排除标准

  • Outborn neonates
  • Neonates requiring resuscitation
  • Not obtaining parental consent
  • Neonates born to mother with hemodynamic instability, placenta previa or abruption placentae and multiple gestations
  • Neonates with major congenital malformations and fetal hydrops.

结局指标

主要结局

Hematocrit at time of cord clamping and within 24 hours of life

时间窗: birth to 24 hours of life

次要结局

  • 1)Transcutaneous bilirubin at 24 hours of life(2)Incidence of neonatal Hyperbilirubinemia)

研究者

发起方
Dr MANU RAJAN IDICULA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr saipavankumar M

MOSC medical college

研究点 (1)

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