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

Owlet

Status: Completed

Conditions: Pregnancy

Treatments: Other: Data Collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04450251

OWLET-01

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

173 participants in 1 patient group

Pregnant women, at least 24 weeks gestation

Treatment:

Other: Data Collection