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临床试验/NCT06608654
NCT06608654尚未招募不适用

The New Application of Electronic Endoscope in the Visual Diagnosis and Treatment of Intrauterine Fetal Distress During Labor

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年10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
15
试验地点
1
主要终点
fetal distress rate

研究概览

简要总结

Fetal distress is a common emergency in obstetrics, which refers to the combined symptoms of fetal health and life in utero due to acute or chronic hypoxia, with an incidence of 2.7% to 38.5%. Fetal distress is mainly related to abnormal amniotic fluid, umbilical cord entanglement and compression, which is an important reason for the increase of cesarean section rate during delivery. At present, the diagnosis of fetal distress mainly relies on electronic monitoring of fetal heart, and the false positive rate is high. Intrauterine pressure catheter has not been widely used because of the little effect of intrauterine treatment and the increase of infection. Endoscopy has been widely used in the diagnosis and treatment of various specialties at present, but the diagnosis and treatment during childbirth are still in a blind area. The characteristics of endoscopic visualization provide a new idea for the diagnosis and treatment of fetal distress during delivery, especially for the etiological diagnosis and treatment of umbilical cord factors. The use of intraauterine endoscope during delivery can make up for the defects of intrauterine pressure catheter, realize the visual diagnosis of the causes of fetal distress such as oligoamniotic fluid, meconium contamination of amniotic fluid, umbilical cord compression caused by entangling and true junction, etc. At the same time, it can also improve the intrauterine environment by perfusion of saline for the causes of fetal embarrassment, correct fetal distress, and extend the observation time during labor. It is beneficial to reduce caesarean section during labor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Subjects aged 20-45 years with single pregnancy;
  • Intrauterine fetal distress occurs during labor (during the first stage of labor), and the fetal membrane was already broken;
  • Fetal heart monitoring category II, after stopping oxytocin, oxygen inhalation, change of position, intravenous fluid and other measures can not improve;
  • Understand the research procedures, be able to follow the procedures of the research protocol, and voluntarily sign a written consent.

排除标准

  • Type III fetal heart monitoring for pregnant women who require emergency c-section
  • Pregnant women with GBS positive
  • Pregnant women suspected of chorioamniotic infection
  • Pregnant women have signs of reproductive system infection (vaginal inflammation, cervicitis, uterine infection)
  • Pregnant women suspected of uterine rupture
  • Pregnant women with abnormal contractions: excessive strong contractions
  • Check the fetus for serious deformities during pregnancy
  • Check pregnant women with serious abnormal functions of cardiovascular system, urinary system, digestive system, reproductive system and other organs

结局指标

主要结局

fetal distress rate

时间窗: through study completion, an average of 1 year

fetal distress rate during first stage of labor

次要结局

  • vaginal delivery rate(through study completion, an average of 1 year)
  • Incidence of maternal infection(through study completion, an average of 1 year)
  • Neonatal asphyxia rate(through study completion, an average of 1 year)
  • neonatal NICU admission rate(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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