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A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring

Sponsored by Bloom Technologies

About this trial

Last updated 4 years ago

Study ID

NST-01-2020-EU

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
Female

Trial Timing

Ended 5 years ago

What is this trial about?

Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional. Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.

What are the participation requirements?

Inclusion Criteria

* Pregnant woman ≥ 18 years old

* Gestational age ≥ 32 weeks and 0 days

* Singleton pregnancy

* Ability to read and understand Dutch or English

* Willingness to participate in the study

Exclusion Criteria

* Implanted pacemaker or any other implanted electrical device

* Plurality higher than 1

* History of allergies to skin adhesives

* Contraindication to the use of the CTG