N/A
N=55
Medical Grade, Smartphone-based, Fetal Heart Rate Monitor for Outpatient Use
Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT04232215 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Device Ease of Use — 72.8; 75.1 score on a scale — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HeraBEAT™ (Device); Doppler fetal heart rate monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Ease of Use |
72.8; 75.1 | 0.64 |
| PRIMARY Accurate Fetal Heart Rate Detection Where Values Are Between 110 and 160 Bpm |
40; 42 | 0.63 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 40 (class 3 obesity)
Data sourced from ClinicalTrials.gov (NCT04232215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.