Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

Overview

Owlet Baby Care, Inc. has developed a wearable fabric band pregnancy monitor, to be worn around the maternal abdomen incorporating electrocardiogram sensors. The purpose of this proposed test is to collect overnight "at-home" fetal ECG recordings on women during the second half of pregnancy using the pregnancy monitor.

Full Title of Study: “Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2021

Interventions

  • Other: Data Collection
    • Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.

Arms, Groups and Cohorts

  • Pregnant women, at least 24 weeks gestation

Clinical Trial Outcome Measures

Primary Measures

  • The objective of this study is to collect observational fetal ECG readings with a novel wearable device
    • Time Frame: Up to 16 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Pregnant woman, 18 years of age and up.
  • Singleton or twin pregnancy.

Exclusion Criteria

  • Self-reported substance abuse problems.
  • Anyone unable or unwilling to give informed consent.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Owlet Baby Care, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kenneth Ward, MD, Principal Investigator, Owlet Baby Care, Inc.
  • Overall Contact(s)
    • Kenneth Ward, MD, 801-647-1209, kward@owletcare.com

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