Clinical Trials Logo
  1. Home
  2. Pregnancy
  3. NCT04450251
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A