A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- FHR
研究概览
简要总结
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation > 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.
Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.
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
- 是
入选标准
- •Female age between 18-50-year-old
- •Singleton pregnancy.
- •Should be at and above 32+0 weeks of pregnancy.
- •Able to speak and read English to understand and sign the Informed Consent.
排除标准
- •Participants with an intellectual or mental impairment.
- •Participants with a known allergy or hypersensitivity to ECG gel electrodes.
- •Known fetal cardiac or genetic abnormality.
- •Clinically unstable participants who require immediate medical care.
- •Participants with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
- •Participants with implantable electronic devices such as pacemaker or ICD.
- •Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)
结局指标
主要结局
FHR
时间窗: From 32 weeks gestation to labour
The 95% confidence limits for the 95% limits of agreement (LoA) for FHR are within -10 and 10 bpm
MHR
时间窗: From 32 weeks gestation to labour
The 95% confidence limits for the 95% limits of agreement (LoA) for MHR are within -8 and 8 bpm
PPA
时间窗: From 32 weeks gestation to labour
The positive percentage agreement (PPA) for UA using femom with respect to Tocodynamometry (TOCO).
次要结局
- Femom NST vs NST(From 32 weeks gestation to labour)