NCT05294211已完成不适用
Marani Prenatal Connected Care (M•Care) Safety and Effectiveness Study
Marani Health1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fetal Heart Rate (FHR)
研究概览
简要总结
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Able to provide informed consent and follow study instructions
- •18 years of age or older
- •Pregnant subjects ≥ 32 weeks' gestation
- •Singleton pregnancy
- •BMI ≥15, pre-pregnancy
- •BMI ≤45, pre-pregnancy
- •Belly circumference ≥80 cm and ≤ 130 cm
排除标准
- •Known major fetal malformation or chromosome abnormality
- •Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation
- •Participants with implanted electronic devices (pacemakers, defibrillator, etc.)
- •Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study
- •Medical or obstetric problem that in the investigator's opinion would make the participant incapable of taking part in the study
- •In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session
- •History of skin allergies to cosmetics and lotions
- •Known allergies to silver, nylon, or polyester
研究组 & 干预措施
M•care™ System + CTG
Experimental
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
干预措施: M•care™ System (Device)
M•care™ System + CTG
Experimental
The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
干预措施: Cardiotocography (CTG) (Device)
结局指标
主要结局
Fetal Heart Rate (FHR)
时间窗: Up to 120 minutes
FHR as measured by the M•care System versus standard of care CTG device
Maternal Heart Rate (MHR)
时间窗: Up to 120 minutes
MHR as measured by the M•care System versus standard of care CTG device
次要结局
- Uterine Contractions (UC)(Up to 120 minutes)
研究者
研究点 (1)
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