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临床试验/NCT03862976
NCT03862976已完成不适用

Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Federico II University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019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
28
试验地点
2
主要终点
cesarean section

研究概览

简要总结

Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation.

Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate.

Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton gestation
  • 18 years to 50 years
  • High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

排除标准

  • 未提供

结局指标

主要结局

cesarean section

时间窗: at the time of delivery

incidence of cesarean section

次要结局

  • birth weight(at the time of delivery)
  • neonatal death(28 days of live of the neonate)
  • gestational age at delivery(at the time of delivery)
  • admission to neonatal intensive care unit(at the time of delivery)
  • APGAR score at delivery(at the time of delivery)

研究者

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

Gabriele Saccone

doctor

Federico II University

研究点 (2)

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