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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 (i.e., download App, operate BT etc.).
  • 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).

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Yvonne Butler Tobah, M.D.

Cerrado para la inscripción

Contact information:

Heather LaBrec

(507)293-3446

LaBrec.Heather@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20476256

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