The Fetal EKG Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Fetal EKG Study

Conditions
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Labor

Intervention / Treatment
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* Device: Fetal Heart Rate Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent 18 years old or older. Gestational age of 24-42 weeks. Any method of fetal heart rate monitoring. Pregnant women in labor as well as women who are not in labor. Pregnant women who are admitted to labor and delivery for scheduled c-sections. Exclusion Criteria: Women unable to consent Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity Women in extremis (in severe pain, etc.) Women who are using the Mindchild device for clinical monitoring.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women in labor<br>Pregnant women, women in labor, and women who are admitted to labor and delivery for scheduled c-sections will form the eligible population for recruitment into our study. | Device: Fetal Heart Rate Monitor<br>* Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes<br>* Other names: Mindchild Meridian Fetal Heart Rate System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative FHR | Quantitative analysis of fetal heart-rate data recorded during labor using advanced mathetmatical techniques, including pattern-recognition analysis using EKG electrodes applied to the maternal abdomen. | During Labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine contractions | Uterine contractions will be identified by analyzing data from surface electrodes to identify patterns consistent with uterine muscle coordinated shortening. These data will be compared to data from either the external tocometer or the internal IUPC. Cross correlation analysis will be used to compare the two signals and validate the analysis of uterine EMG signal. | During labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fetal Heart Rate, Fetal EKG, FHR tracing, fetal R-waves