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临床试验/NCT03150641
NCT03150641已完成不适用

Maternal Blood Loss With Delayed Cord Clamping During Cesarean Delivery at Term

Columbia University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2017年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Maternal change in hemoglobin on post-operative day #1

研究概览

简要总结

The purpose of this research study is to find out how delaying cutting the umbilical cord until one minute after delivery of the baby during a cesarean impacts the amount of blood the mother loses during surgery. The study will also examine the benefits to the newborn from delayed cord clamping during cesarean.

详细描述

After delivery of a baby, the umbilical cord is cut to separate the baby from the placenta and the mother. The best time to cut the umbilical cord of full term babies is unknown. Traditionally, the umbilical cord is cut immediately at birth. There is however, continued blood flow from the placenta to the baby after delivery and so there may be a benefit to the baby from waiting to cut the cord until one minute after delivery. Studies show that delaying cutting the cord until at least one minute after delivery increases a full term baby's blood count in first two days of life and increases the baby's iron levels. The impact of delaying cutting the umbilical cord on a mother's health is not fully known. Delaying cutting the cord has minimal impact on the mother's health when the baby is delivered vaginally, but it is not known how delaying cutting the cord impacts the mother's health (and specifically the amount of blood a mother loses at delivery) when the baby is delivered by cesarean.

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

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton gestation
  • Scheduled cesarean delivery at term (>=37 weeks)

排除标准

  • Placenta previa
  • Placenta abruption
  • Intrauterine growth restriction with abnormal Dopplers
  • Fetal anomalies
  • Known fetal anemia
  • Planned cord blood banking
  • Preeclampsia
  • Significant maternal anemia (Hgb <=7)

结局指标

主要结局

Maternal change in hemoglobin on post-operative day #1

时间窗: Baseline to postoperative day #1 (range 1-4 days)

Difference in hemoglobin between routine pre-op CBC and a postpartum CBC collected on postoperative day #1, by venipuncture

次要结局

  • Maternal blood transfusion(From day of surgery to postpartum discharge (average 3-4 days))
  • Postpartum hemorrhage(From day of surgery to postpartum discharge (average 3-4 days))
  • Estimated blood loss(Day of surgery)
  • Need for Need for additional uterotonics(Day of surgery)
  • Venous cord blood Hgb/Hct(Day of delivery)
  • Neonatal Hgb/Hct(Day 0-2 of life)
  • APGAR scores(Day of delivery)
  • Need for phototherapy for jaundice(From birth to hospital discharge (average 3-4 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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