A Study to Evaluate Smartphone-based Fetal Heart Rate Monitor for Self Administration by Low-risk Pregnant Women

Overview

About this study

The purpose of this study is to evaluate the functionality and acceptability of HeraBEAT™ Smartphone based Fetal Heart Rate monitoring device when self-administered and used by low-risk pregnant women to monitor fetal heart rate during pregnancy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • At least 18 years of age.
  • Able to speak, read and understand English.
  • Able to provide informed consent (i.e., no impairments or barriers).
  • 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 cranial or cardiac anomalies on 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 requiring outpatient or inpatient monitoring for clinical care.
  • 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 PE/DVT/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/CF 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yvonne Butler Tobah, M.D.

Closed for enrollment

Contact information:

Heather LaBrec

(507)293-3446

LaBrec.Heather@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20476256

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