Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- FHR Deming Regression
研究概览
简要总结
To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor & delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC and photo plethysmograph MHR FDA approved predicates
详细描述
The study is a single-center prospective paired comparison trial, to determine the equivalence of the Monica Novii Patch System with FDA cleared Doppler FHR, TOCO UC and photo plethysmograph MHR Predicate. Patients admitted for threatened pre-term labor and for pre-term labour & delivery will be monitored with both devices simultaneously for FHR, UC, and MHR. Only the data from predicate devices will be available to the clinical care team. The equivalence of the Novii data will be compared to that of the simultaneously obtained predicate device data. Since TOCO UC and Doppler FHR are prone to artefact or error in a Pre-Term Labor population, the principal investigator or a member of the study team will decide on:
- One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO UA from each of the admitted threatened pre-term labor subjects, when the subject is experiencing contractions as demonstrated by the TOCO UC trace and these contractions represent the clinical presentation.
- One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO UA from each of the pre-term labor & delivery subjects ending as close to delivery as practical. As above the TOCO UC contractions should represent the clinical presentation. The selection of the 30 min periods will be based on data from the predicate only (the Novii FHR and UC data will not be available to the study team). The two 30 min periods will be used for the statistical equivalence calculation.
All recorded data will be made available for visual review.
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
- •She will require pre-term labor (at least 32 weeks 0 days gestation) monitoring with a singleton longitudinal, breech, transverse lie pregnancy.
- •She had none of the exclusion criteria
排除标准
- •The presence of any of the following factors or conditions would exclude the patient from consideration as a subject:
- •Known major fetal malformation or chromosome abnormality.
- •Multiple gestation
- •A condition for which cesarean will likely be carried out shortly.
- •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. Prisoners.
结局指标
主要结局
FHR Deming Regression
时间窗: 30min
Standard linear regression of y on x is not appropriate in this situation as the predicate device is not considered a gold standard, but as a device providing a measurement which may itself be subject to error, whereas the standard linear regression method assumes x to be measured without error. Deming regression is a method for calculating the regression line y=α+βx when both variables are subject to error, and the ratio of the error variances in x and y is known (and will be assumed to be equal to 1 in this analysis).
次要结局
- MHR deming regression(30min)
- UC percent agreement(30min)
- UC Positive percent agreement(30min)
- MHR Percent agreement(30min)
- MHR bland altman(30min)
- FHR Percent Agreement(30min)
- FHR Bland Altman(30min)