AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maternal Heart Rate (MHR)
研究概览
简要总结
This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.
详细描述
The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a singleton pregnancy
- •Should be at and above 28 weeks of pregnancy
- •Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy
- •Able to speak English or have access to an interpreter and provide Informed Consent
排除标准
- •Participants with an intellectual or mental impairment
- •Participants with a known allergy or hypersensitivity to ECG gel electrodes
- •Participants in pain, with contractions or in labour
- •Known fetal cardiac or genetic abnormality
- •Participant with a pacemaker
结局指标
主要结局
Maternal Heart Rate (MHR)
时间窗: 60 minutes
MHR agreement between Biorithm Research Kit and standard of care (CTG)
Fetal Heart Rate (FHR)
时间窗: 60 minutes
FHR agreement between Biorithm Research Kit and standard of care (CTG)
次要结局
未报告次要终点