NCT05498298

Brief Summary

Bloom Technologies is developing a wearable device for monitoring pregnancy. In this study, Bloom Technologies wants to investigate the reliability of this new technology. For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

August 9, 2022

Last Update Submit

December 13, 2022

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

  • Reliability in fetal heart rate extraction

    Percentage of a recording with a fetal heart rate signal extracted

    40 minutes

  • Reliability in maternal heart rate extraction

    Percentage of a recording with a maternal heart rate signal extracted

    40 minutes

Study Arms (1)

Gtec

EXPERIMENTAL
Device: Biopotentials measurement with gtec device

Interventions

Biopotentials measurement with gtec deviceDEVICE

A measurement of 40 minutes is performed with the gtec g.Hlamp to collect biopotential signals. 32 electrodes are attached to the body (abdomen, thorax and back).

Gtec

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman ≥ 18 years old
  • Gestational age ≥ 30 weeks and 0 days
  • Singleton pregnancy
  • Ability to read and understand English or Spanish
  • Willingness to participate in the study

You may not qualify if:

  • Implanted pacemaker or any other implanted electrical device
  • History of allergies to skin adhesives
  • Irritated or lesioned skin at the electrodes locations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Perinatal Services

Phoenix, Arizona, 85004, United States

Location

Study Officials

  • Ravindu Gunatilake

    Valley Perinatal Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 12, 2022

Study Start

August 3, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

US(1)