Accuracy and Reliability of a New Intrapartum Fetal Heart Rate, Maternal Heart Rate, and Uterine Contraction Monitoring Method Compared With Food and Drug Administration (FDA) Approved Techniques.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA)
研究概览
简要总结
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
详细描述
The study is being done to test the performance of a Novii Wireless Patch System for following the baby's and mother's heart rates and uterine contractions during labor. We want to find out if the new monitor works as well as other types of monitors that are usually used: Doppler Fetal Heart Rate (FHR), Scalp FHR, Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC).
80 patients will be monitored during the study.
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
- 是
入选标准
- •A woman will be considered for inclusion in the study if she fulfills all of the following criteria:
- •She has a term or near term (≥36 completed weeks) singleton gestation in a cephalic presentation and has been admitted to the Labor and Delivery Unit .
- •She is in the latent phase of spontaneous labor, or has been admitted for induction of labor.
- •She has given her informed consent to participate as a subject.
- •She has none of the exclusion criteria.
排除标准
- •Known major fetal malformation or chromosome abnormality.
- •Multiple gestation
- •A condition for which cesarean will likely be carried out shortly.
- •Subject plans not to have electronic fetal monitoring.
- •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 would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to adhesives).
- •Parturient is under age
- •Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
- •Inability to understand the consent information due to medical illness or diminished intellectual capacity, or insurmountable language barrier.
- •Potential for coercion, e.g. Medical Center employees, prisoners.
结局指标
主要结局
Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA)
时间窗: through study completion, an average of 1 year
PPA(%)=(a/(a+C))x100, where "a" represents the number of 2 second epochs when the Novii FHR is within +/-10% of the predicate device FHR for each 2 second epoch, and "c" are the number of 2 second epochs when the Novii FHR is not within +/- 10% of the predicate device FHR or is absent.
次要结局
- Uterine activity Positive Percentage Agreement (from Interpretable Data)(through study completion, an average of 1 year)
- Mean Percentage MHR Equivalence(through study completion, an average of 1 year)
- Uterine Activity (UA) Sensitivity (from Individual Contractions)(through study completion, an average of 1 year)
- Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA)(through study completion, an average of 1 year)
- Mean Percentage FHR Equivalence(through study completion, an average of 1 year)