Can Conventional ECG Technology Capture Fetal Cardiac Activity?

University of Washington

Status: Enrolling

Conditions: Fetal Monitoring

Treatments: Device: Holter Device

Study type: Interventional

Funder types: Other

Identifiers

NCT03111173

STUDY00001556

Details and patient eligibility

About

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.

Full description

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. To obtain the raw FHR data from this standard device we will use the currently approved "fetal EEG" monitor. The important distinction is that "fetal EEG" monitor will not be connected to fetal scalp electrode, but, rather, get the data from the regular, more routinely used and non-invasive Doppler FHR monitor. We expect that we will be able to validate our algorithm with our maternal and fetal ECG channels to derive the FHR.

We will attach a Holter ECG device (4 electrodes) and a standard Doppler FHR device to a pregnant woman who is between 32 weeks gestation and full term. ECG leads will be placed in four corners of the abdomen. The targeted length of the recording will be 30 minutes. The subject will remain supine and resting while the device is recording. Additionally, the recently approved fetal EEG monitor will be connected to the Doppler FHR device to allow us to obtain a "digital copy" of the standard FHR recording. We will do that in order to have the comparison during the offline processing of the abdominal ECG with regard to the location of the fetal R peaks. This procedure will be done after the subject's routine antepartum testing. No women in active labor will be recruited.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Holter device

Other group

Description:

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

Treatment:

Device: Holter Device