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

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Owlet Baby Care, Inc.

Lehi, Utah, 84043, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

The objective of this study is to collect observational fetal ECG readings with a novel wearable device

Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Owlet Baby Care, Inc.

Industry

Registry information

Official study title

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2023
First posted: Jun 29, 2020
Registry last updated: Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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