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NCT04450251 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04450251
Other study ID # OWLET-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 29, 2018
Est. completion date June 30, 2021

Study information
Verified date June 2020
Source Owlet Baby Care, Inc.
Contact Kenneth Ward, MD
Phone 801-647-1209
Email kward@owletcare.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Owlet Baby Care, Inc. Lehi Utah

Sponsors (1)
Lead Sponsor Collaborator
Owlet Baby Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The objective of this study is to collect observational fetal ECG readings with a novel wearable device Up to 16 weeks
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