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临床试验/NCT05610345
NCT05610345已完成不适用

The Effect of Placental Cord Drainage on Postpartum Blood Loss

University of Tennessee1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
1
主要终点
Qualitative Blood Loss

研究概览

简要总结

To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery

详细描述

Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Singleton Gestation
  • •Ages 18-45
  • •English Speaking
  • •Third Trimester Gestation

排除标准

  • •Operative Vaginal Delivery
  • •Multiple Gestation
  • •Cesarean Delivery
  • •Episiotomy
  • •3rd or 4th degree laceration
  • •Less than the Third Trimester of Pregnancy
  • •Chorioamnionitis
  • •History of Postpartum Hemorrhage
  • •Macrosomic Infant

研究组 & 干预措施

Placenta Blood Drained

Experimental

Immediately after delayed cord clamping and cutting of the umbilical cord, the cord will be unclamped and blood with be drained until cessation of flow.

干预措施: Placental Blood Drainage (Procedure)

Placenta Blood Not Drained

Active Comparator

This is the control group. The cord will not be unclamped.

干预措施: Placenta Blood Not Drained (Procedure)

结局指标

主要结局

Qualitative Blood Loss

时间窗: Through delivery completion, on average 30 minutes

Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges

次要结局

  • Blood Loss > 500 cc(30 minutes to 1 hour after delivery)
  • Need for Blood Transfusion(Up to 24 hours postpartum)
  • Duration of Third Stage of Labor(On average 30 minutes)
  • Postpartum Hemorrhage(30 minutes to 1 hour after delivery)
  • Retained Placenta(30 minutes after delivery)
  • Percent Drop in HgB and Hct(Up to 48 hours following delivery)
  • Additional Uterotonic Administration(30 minutes to 1 hour following delivery)
  • Endometritis(Up to 12 weeks following delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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