跳至主要内容
临床试验/NCT03013569
NCT03013569已完成不适用

Can Spontaneous Fetal EEG Be Recorded During Labor Using the Established Fetal Scalp Electrode Heart Rate Monitoring System?

University of Washington1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Recording spontaneous EEG during labor

研究概览

简要总结

This is a pilot feasibility study for a new application of an approved fetal heart rate monitoring device system. The objective of this study is to validate the feasibility of acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the routinely used scalp fetal heart rate (FHR) monitor.

详细描述

The investigators' objective is to validate the feasibility of acquiring the new modality of human fetal bioelectrical activity, EEG, derived from the routinely used scalp FHR monitor.

The investigators expect that in some newborns acidemia will be detected based on cord blood pH. In these babies, the investigators will trace back the EEG recordings to further validate whether the EEG - FHR patterns were predictive of this outcome. In fetal sheep model of human labour the investigators were able to see the onset of acidemia <55 min ahead of severe drop of pH to <7.00. This corresponded to an average pH of 7.20.

The investigators hypothesize that they will be able to acquire fetal EEG during labour such that the normal behavioural sleep states will be observed and their disruption, followed by emergence of the pathognomonic EEG-FHR pattern will be seen with incipient acidemia.

At-risk pregnant women routinely admitted for intrapartum monitoring will be asked to consent when the Fetal Scalp Monitor (FSM) is placed. The attachment will be such that no direct contact to mother or baby will be established and hence no current from device to the mother or the baby will be possible. The EEG fetal health monitoring device is attached to the routinely used fetal heart rate (FHR) GE HC Corometrix 250cx monitor. The EEG recording will commence only once the FSM is attached; the attachment of the FSM will be performed based on medical necessity, not based on the need to record EEG.

Duration of recording will be dependent on the labour duration. However, the investigators will seek for a minimum of 30 minutes and continue as long as medically possible per subject.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women in labor, with medical complications of pregnancy, such as IUGR, hypertension, diabetes, or obesity (BMI over 30).

排除标准

  • Maternal or fetal infection or bleeding disorder;
  • Birth through Caesarian section will only be excluded if decided a priori;
  • Non-English speaking.

结局指标

主要结局

Recording spontaneous EEG during labor

时间窗: 12 month recruitment period

The investigators will record spontaneous fetal EEG activity during labor using a custom-build IRB-approved fetal EEG device. The validity of the recorded data will be analyzed based on the physiological characteristics of the data such as amplitude and frequency properties as well as the behavioral state architecture (duration of low voltage/high frequency and high voltage/low frequency states as well as of the indeterminate states). The data will be analyzed in conjunction with the accompanying fetal heart rate recordings which also show behavioral state fluctuations.

次要结局

  • Fetal acidemia(12 month recruitment period)

研究者

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

Martin Frasch

Research Assistant Professor, Obstetrics and Gynecology

University of Washington

研究点 (1)

Loading locations...

相似试验

Spontaneous Fetal EEG Recording During Labor | 临床试验