NCT06683183

Brief Summary

The aim of this clinical pilot study is

  1. 1.to evaluate the ability of the wearables to detect fetal heart rate
  2. 2.to evaluate the ability to distinguish the fetal ECG from the ECG of the mother

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2025

Completed
Last Updated

April 18, 2025

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

November 8, 2024

Last Update Submit

April 17, 2025

Conditions

Fetal Heart Rate Tracing

Outcome Measures

Primary Outcomes (1)

  • Fetal heart rate

    15 minute data collection

Study Arms (1)

Pregnant women

Pregnant women will wear the set of wearables (chest band, smart watch and arm band) for 15 minutes. In addition, pregnant woman's ECG and fetal heart rate will be measured with hospital's patient monitor.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women recruited for the study are registered at the hospital ward for pregnant women. The data collection will be conducted after the routine fetal monitoring and will not affect normal monitoring practices.

You may qualify if:

  • duration of pregnancy at least 29+0 weeks
  • single pregnancy
  • age at least 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

February 19, 2025

Primary Completion

April 11, 2025

Study Completion

April 11, 2025

Last Updated

April 18, 2025

Record last verified: 2024-11

Locations

FI(1)