NCT01881685已完成不适用
Fetal Intrapartum Heart Rate FHR/ECG Study
Mindchild Medical Inc.2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Quantitative FHR patterns predictive of adverse neonatal outcome
研究概览
简要总结
The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.
详细描述
The purpose of the study is to:
- evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device;
- investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and;
- develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle.
For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
- •18 years old or older
- •Women with the diagnosis of fetal intrauterine growth restriction may be included.
排除标准
- •Speakers of languages other than English
- •Gestational age less than 24 weeks 0 days
结局指标
主要结局
Quantitative FHR patterns predictive of adverse neonatal outcome
时间窗: During Labor
1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.
次要结局
- Uterine contraction measurement(During Labor)
研究者
研究点 (2)
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