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

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Data Collection

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• United States
  • Utah
    • Lehi, Utah, United States, 84043
      • Owlet Baby Care, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Approximately 500 pregnant women 24 weeks gestation and up in the second or third trimester of pregnancy will be screened into the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women, at least 24 weeks gestation	Other: Data Collection; Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Owlet Baby Care, Inc.
• Investigators: Principal Investigator: Kenneth Ward, MD, Owlet Baby Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): May 10, 2020
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Owlet; Pregnancy Tracker; Owlet Band; Wearable Tech
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: OWLET-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No