Clinical Trials

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).