跳至主要内容
临床试验/CTRI/2025/12/098753
CTRI/2025/12/098753尚未招募不适用

Outcomes of Neonates Born at or Above 36 Weeks of Gestation With Physiological Cord Clamping: A Prospective Analytical Study

Dr Oishee Giri1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
118
试验地点
1
主要终点
Heart rate and SpO2 from birth till 5mins of life

研究概览

简要总结

Physiological intact cord management involves maintaining umbilical circulation until the newborn establishes spontaneous respiration and cardiorespiratory stability or until natural placental expulsion occurs. This practice allows continued placental transfusion and optimizing neonatal transition. Although delayed cord clamping is globally supported, limited data exist from Indian tertiary centers on immediate postnatal outcomes following this practice in late preterm and term neonates. This study aimed to evaluate heart rate and oxygen saturation at 5 minutes of life following physiological intact cord management, with secondary objectives of assessing hemoglobin and bilirubin at 72 hours. Preterm neonates or those with major congenital anomalies were excluded. A prospective observational study enrolled 118 neonates more than equal to 36 weeks gestation (both LSCS and NVD) at a tertiary care teaching hospital. Physiological intact cord management will be performed per standardized protocol. Heart rate and oxygen saturation will be measured at 5 minutes, hemoglobin and bilirubin were assessed at 72 hours. Data will be analyzed using SPSS version 26. Physiological intact cord management demonstrated superior cardiorespiratory and hematological outcomes while reducing the need for phototherapy compared to conventional clamping. Sustained placental transfusion likely supports improved neonatal transition. Physiological intact cord management enhances neonatal cardiorespiratory transition and hematological status without increasing jaundice risk, supporting its inclusion in standard perinatal care.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All babies born at or above 36weeks of gestation both normal vaginal delivery and cesarean section.

排除标准

  • Babies born below 36 weeks of gestation Babies born with gross congenital anomalies not compatible with life Life threatening health condition of the mother where cord needs to be cut immediately for life saving purposes.

结局指标

主要结局

Heart rate and SpO2 from birth till 5mins of life

时间窗: Heart rate and SpO2 from birth till 5mins of life

次要结局

  • Hemoglobin levels at 72hrs of life.(Incidence of birth asphyxia)

研究者

发起方
Dr Oishee Giri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

OISHEE GIRI

MEDICAL COLLEGE AND HOSPITAL KOLKATA

研究点 (1)

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