NCT02320279

The Fetal EKG Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Mindchild Medical Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.

Detailed description

Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis. * Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor. * Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval. * Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes. * Specific Aim 5: Collect clinical data related to medication usage and hypoxia.

Conditions

• Labor

Interventions

Type	Name	Description
DEVICE	Fetal Heart Rate Monitor	Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes

Timeline

• Start date: 2013-10-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2014-12-19
• Last updated: 2021-11-16

Locations

1 site across 1 country: United States