Recruiting

ECG Technology

Sponsor:

University of Washington

Code:

NCT03111173

Conditions

Fetal Monitoring

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Holter Device

Study Details

Brief summary:

This is a feasibility study for a new application for capturing fetal cardiac activity. The objective of this study is to determine if it is feasible to capture a fetal ECG signal using a Holter ECG device. As comparison we will use a standard Doppler Fetal Heart Rate (FHR) device.

Conditions

Fetal Monitoring

Study ID

NCT03111173

Start date

Jun 2, 2017

Status verified date

Jan, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Singleton or twin pregnant women at 32 weeks gestation to full term after routine antepartum testing.

Exclusion Criteria:

  • None.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

other: Holter device

Holter device to be attached to a Singleton or twin pregnant women at 32 weeks gestation to full term

Interventions

Holter Device

MyECG E3.80 Holter Recorder

Primary outcome measure

  • Successful extraction of fetal ECG from the maternal abdominal ECG signal [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Martin G Frasch, MD, PhD

206-543-5892mfrasch@uw.edu

Amy Gest, MPA

206-359-1961agest@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Martin G Frasch, MD, PhD

206-543-5892mfrasch@uw.edu

Amy Gest, MPA

206-359-1961agest@uw.edu

Principal Investigator:

Martin Frasch, MD, PhD

More Information

Sponsor

University of Washington

Last update posted

Jan 18, 2024

Last verified

Jan, 2024

Keywords

  • ECG
  • Fetus
  • R peak extraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-01-18.