Feasibility and Acceptability of a Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use: the HeraBEAT™ Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Device Ease of Use
研究概览
简要总结
Researchers are assessing the ease of use and accuracy of the HeraBEAT™ device, a new device used with a smartphone to monitor fetal heart rate during pregnancy.
详细描述
The HeraBEAT™ is a wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy. The HeraBEAT™ device safety and performance claims allow continuous and accurate measurement of fetal heart rate (FHR) and maternal heart rate (MHR) throughout the pregnancy starting at 12 weeks gestation.
Technologically, HeraBEAT™ is similar to other FHR devices currently on the market in terms of device usage but differ by design in its interface. The HeraBEAT™ device uses a smartphone-based interface, with real time instructions for expectant mothers for determining both MHR and FHR.
This study will recruit low risk expectant mothers from the Obstetrics and Gynecology Department at Mayo Clinic Rochester. This is a mixed method; single center randomized controlled trial comparing HeraBEAT™ to a standard home fetal Doppler monitor, in the outpatient setting at a single academic institution, in the mid-west United States. The overall study will be guided by an assessment of device functionality and user acceptability, as well as an evaluation of the impact of the device on expectant mother's perception of fetal well-being, as measured by standardized surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •At least 18 years of age
- •Able to speak, read and understand English
- •Able to provide informed consent
- •Owns a suitable iOS or Android device and demonstrates average control and basic understanding of using a smartphone
- •At least 12 weeks gestation
- •Pregnancy documented as low risk
排除标准
- •Any observed anomalies on first trimester dating or formal ultrasound
- •Multifetal gestation
- •Maternal history of defibrillation
- •Maternal history of electro-surgery
- •Patients with external electrical stimulators, cardiac pacemakers or requiring use of MRI or other high frequency medical equipment
- •Clinical judgment that determines that the pregnancy is at high risk for complications
- •Any of the following high risk factors would disqualify the mother for the study:
- •Abnormal fetal anatomy
- •Chronic hypertension, including severe hypertension (>160/110)
- •Possible ectopic pregnancy or pregnancy of unknown location
- •Multi-fetal pregnancy
- •Hypertensive disorders (chronic hypertension, gestational diabetes, preeclampsia)
- •Prior Pulmonary Embolism / Deep Vein Thrombosis / stroke
- •Anticoagulation during prior pregnancy (e.g. antiphospholipid antibody syndrome)
- •Prosthetic heart valve (non-bio)
- •Pulmonary hypertension
- •Mothers currently taking Immunosuppressants, Prednisone > 10mg per day)
- •Women with mental health disorders (including eating disorders, severe depression, on antipsychotics)
- •Recurrent pregnancy loss (>2 losses)
- •Current maternal malignancy
- •Prior myocardial infarction/cardiomyopathy
- •Bio-prosthetic heart valves
- •Marfan syndrome
- •Active liver disease (e.g. hepatitis)
- •Congenital heart disease
- •Coagulopathies including thrombophilias and bleeding disorders.
- •Pre-existing diabetes
- •Genetic disease/Cystic Fibrosis testing/anomalies in prior child
- •Incompetent cervix (prior cerclage)
- •Isoimmunization (Rh, Kell, etc.)
- •History of transplant or currently on Dialysis
- •Prior 2nd or 3rd trimester loss
- •Human Immunodeficiency Virus (HIV)
- •Inflammatory bowel disease
- •Asthma and currently on steroid to control disease
- •History of preterm delivery <37 weeks
- •BMI >40 (class 3 obesity)
结局指标
主要结局
Device Ease of Use
时间窗: 8 weeks
Measured using the self-reported System Usability Scale (SUS) on 10 items, each on a scale from 1 to 5 (1 = strongly disagree and 5= strongly agree). A composite score is calculated with a range of 0-100 where higher values indicated a high usability of device, whereas lower scores indicate less usability of the device.
Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm
时间窗: 8 weeks
Number of patients to detect a fetal heart rate accurately using the device. An inaccurate assessment is considered any value less than 110 or greater than 160 bpm. A patient with at least one inaccurate value is counted as an event of interest. Patients without an inaccurate event will be counted as a success.
次要结局
未报告次要终点
研究者
Yvonne S. Butler Tobah, MD
Principal Investigator
Mayo Clinic