The Fetal EKG Study

• Conditions: Labor
• Interventions: Device: Fetal Heart Rate Monitor

• Registration Number: NCT02320279
• Lead Sponsor: Mindchild Medical Inc.

Brief 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women in labor	Fetal Heart Rate Monitor	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.

Primary Outcome Measures

Name	Time	Method
Quantitative FHR	During Labor	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.

Secondary Outcome Measures

Name	Time	Method
Uterine contractions	During labor	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.

Trial Locations

Locations (1)

South Shore Hospital; 🇺🇸 South Weymouth, Massachusetts, United States