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临床试验/NCT05727241
NCT05727241尚未招募不适用

The Effect of Three-dimensional Umbilical Cord Coiling Index on Obstetrical and Neonatal Outcomes: a Prospective Study

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Intrauterine growth restriction

研究概览

简要总结

Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death.

The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

详细描述

The umbilical cord connects the growing fetus to the placenta and contains 3 blood vessels, 2 arteries and a vein. The umbilical cord is protected by a layer of Wharton jelly and is characterized by being coiled. This coiling provides the umbilical cord with strength and flexibility simultaneously, and as a result lowers the risk of complications such as torsion of the umbilical cord.

The reason for the formation of this coiling is unknown, but there are many hypotheses such as mobility and rotation of the fetus around the axis of the umbilical cord, a different growth pattern of the blood vessels in the umbilical cord and a special arrangement of the muscles in the walls of the arteries of the umbilical cord.

Umbilical cord index (UCI) is the distance between one coil of the umbilical cord. it is calculated from the inner edge of the wall of an umbilical cord artery or vein to the outer edge of the same vessel in the next coil, the direction is from the edge of the placenta to the fetus. The final value is the average of three readings in three different segments of the umbilical cord.

Previous studies have shown that abnormal coiling of the umbilical cord is associated with adverse perinatal outcome. For example, an umbilical cord that is non-coiled increases the chance of fetal morbidity and mortality, moreover, they have shown that the lack of the usual coiled umbilical cord configuration may result in an umbilical cord that is structurally less able to withstand external mechanical stress, on the other hand, studies from recent years show that hypercoiling - excessive coiling of the umbilical cord is associated with poor obstetric outcomes, such as fetal distress at birth, meconium staining, fetal acidosis, premature birth, intrauterine growth disorder and even fetal death.

The studies carried out on the calculation of UCI include performing these measurements in two dimensions, including Doppler activation, but no studies were carried out in which three dimensions were used. The purpose of the study is to measure UCI using a 3D method in a random sample of 250 patients beyond 24 week of gestation, and to compare pregnancies with hypercoiling, hypocoiling or with a normal number of coils in terms of birth outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Singleton pregnancy
  • Pregnancy week > or = 24.0

排除标准

  • Twin pregnancy
  • Pregnancy week<24
  • Single umbilical cord
  • Insufficient prenatal care
  • Abnormal anatomical fetal findings, abnormal results of aneuploidy screening
  • Premature rupture of membranes
  • Polyhydramnios or Oligohydramnios at the time of recruitment.
  • Intrauterine growth restriction at the time of recruitment

结局指标

主要结局

Intrauterine growth restriction

时间窗: 1 year

The correlation between three-dimensional umbilical cord index and the rate of intrauterine growth restriction

次要结局

  • Meconium staining(2 years)
  • Delivery mode(2 years)
  • Doppler index of the umbilical cord(1 year)
  • fetal distress during delivery(2 years)
  • Cord pH(2 years)
  • Two-dimensional umbilical cord index(1 year)
  • APGAR score(2 years)
  • Newborn intensive care unit admission(2 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr Raneen Abu Shqara

Doctor

Western Galilee Hospital-Nahariya

研究点 (1)

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