Testing a Wearable Monitor for Fetal Heart Rate Estimatio... | NCT04450251

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

NCT04450251

Sponsor

Owlet Baby Care, Inc.

Status

Completed

Last Update Posted

Sep 22, 2025Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Data Collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 29, 2018Actual

Primary Completion Date

May 10, 2020Actual

Completion Date

May 1, 2023Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

16 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women, at least 24 weeks gestation			Other: Data Collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data Collection	Other	Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.	Pregnant women, at least 24 weeks gestation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Ward, MD	Owlet Baby Care, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Owlet Baby Care, Inc.		Lehi	Utah	84043	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided