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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04450251
Enrollment
173
Registered
2020-06-29
Start date
2018-08-29
Completion date
2023-05-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy Tracker, Owlet Band, Owlet, Wearable Tech

Brief 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.

Interventions

OTHERData Collection

Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.

Sponsors

Owlet Baby Care, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to collect observational fetal ECG readings with a novel wearable deviceUp to 16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026