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临床试验/NCT04353544
NCT04353544已完成不适用

Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Spontaneous Vaginal Delivery

Federico II University2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
2
主要终点
change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level

研究概览

简要总结

Policies for timing of cord clamping vary, with early cord clamping generally carried out in the first 60 seconds aLer birth, whereas latercord clamping usually involves clamping the umbilical cord greater than one minute after the birth or when cord pulsation has ceased

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • cephalic presentation
  • spontaneous labor
  • spontaneous vaginal delivery

排除标准

  • multiple gestation
  • preterm gestation
  • induced labor
  • operative delivery
  • hypertension or preeclampsia
  • fetal anomaly
  • abnormal placentation
  • planned cord blood banking
  • maternal bleeding disorder

结局指标

主要结局

change in maternal hemoglobin level on post delivery day 1 compared with the predelivery hemoglobin level

时间窗: day 1 after delivery

The primary outcome was an objective measure of maternal blood loss: the change in maternal hemoglobin level on postdelivery day 1 compared with the predelivery hemoglobin level.

次要结局

  • uterotonic administration(at the time of delivery)
  • jaundice(day 10 of life)
  • need for blood transfusion(at the time of delivery)
  • postpartum hemorrhage(at the time of delivery)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Saccone

principal investigator, medical doctor

Federico II University

研究点 (2)

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