The Fetal EKG Study

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.

Study Overview

• Status: Recruiting
• Conditions: Labor
• Intervention / Treatment: Device: Fetal Heart Rate Monitor

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 Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Adam Wolfberg, MD; Phone Number: 781-624-8000; Email: adam.wolfberg@mindchild.com

Study Locations

• United States
  • Massachusetts
    • South Weymouth, Massachusetts, United States, 02190
      • Recruiting
      • South Shore Hospital
      • Principal Investigator: Adam Wolfberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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. These women will be identified by a study staff-member who will ask on-call physicians, midwives, and nurses working on Labor and Delivery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women in labor; 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; Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes; Other Names: Mindchild Meridian Fetal Heart Rate System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mindchild Medical Inc.
• Investigators: Principal Investigator: Adam Wolfberg, MD, South Shore Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Fetal Heart Rate; Fetal EKG; FHR tracing; fetal R-waves
• Other Study ID Numbers: South Shore Fetal EKG study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No