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

Last updated: September 16, 2025
Sponsor: Owlet Baby Care, Inc.
Overall Status: Completed

Phase

N/A

Condition

Pregnancy

Treatment

Data Collection

Clinical Study ID

NCT04450251
OWLET-01
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant woman, 18 years of age and up.

  • Singleton or twin pregnancy.

Exclusion

Exclusion Criteria:

  • Self-reported substance abuse problems.

  • Anyone unable or unwilling to give informed consent.

Study Design

Total Participants: 173
Treatment Group(s): 1
Primary Treatment: Data Collection
Phase:
Study Start date:
August 29, 2018
Estimated Completion Date:
May 01, 2023

Connect with a study center

  • Owlet Baby Care, Inc.

    Lehi, Utah 84043
    United States

    Site Not Available

  • Owlet Baby Care, Inc.

    Lehi 5777224, Utah 5549030 84043
    United States

    Site Not Available

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