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临床试验/NCT04812223
NCT04812223已完成不适用

Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries

Acibadem University2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2021年3月25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
204
试验地点
2
主要终点
Postpartum maternal hemorrhage

研究概览

简要总结

The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

详细描述

Late clamping of the umbilical cord has been shown to have positive effects such as higher neonatal hemoglobin level, higher iron stores in the newborn around three to six months, and better neurological development. In 2017, American College of Obstetricians and Gynecologists (ACOG) recommended a minimum 30-60 seconds delayed clamping of the cord after a minimum of 30-60 seconds, regardless of the delivery method, in both term and preterm newborns. In addition, optimal placental transfusion can be achieved due to strong uterine tonus in vaginal delivery. However, this is not possible due to decreased uterine tonus and time constraint in cesarean delivery. The main concern in delayed clamping and milking of the umbilical cord is the possibility of maternal anemia due to excessive maternal blood loss in the short term, the need for maternal blood transfusion or maternal intensive care support, and the possibility of conditions such as hyperbilirubinemia, symptomatic polycythemia, and long hospital stay that may cause the need for phototherapy in the newborn. Although there are many studies in the literature regarding the neonatal results of the clamping timing of the umbilical cord, there are a limited number of articles regarding the results in patients who underwent term elective cesarean section. The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • > 37 weeks uncomplicated singleton pregnancy
  • Elective cesarean delivery
  • Cesarean section under regional anesthesia

排除标准

  • < 37 weeks pregnancy
  • Surgery performed under general anesthesia
  • Emergent cesarean
  • Multiple pregnancy
  • Medically unstable mother or fetus
  • Uncontrolled maternal diabetes
  • Major congenital malformation of chromosomal abnormality of the fetus
  • Intrauterine growth retardation
  • Prenatal asphyxia suspicion
  • True knot in the umbilical cord
  • İn case of meconium aspiration syndrome suspicion

结局指标

主要结局

Postpartum maternal hemorrhage

时间窗: On postoperative day 0 and day 2

Preoperative and postoperative hemoglobin values will be recorded.

次要结局

  • Neonatal anemia(On postpartum day 2)
  • Newborn positive pressure ventilation(Postpartum 5 days)
  • Postpartum maternal anemia(İn postpartum 48 hours)
  • Neonatal outcomes(Postpartum day 0)
  • Newborn phototherapy need(In postpartum 2 weeks)
  • Postpartum complaints(İn postpartum 48 hours)
  • Neonatal jaundice(On postpartum day 2)
  • Neonatal intensive care unit admission(In postpartum 5 days)
  • Maternal outcomes(On postpartum day 2)

研究者

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

Esra Ozbasli

Assistant Professor

Acibadem University

研究点 (2)

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