The Fetal EKG Study

Labor Clinical Trial

Official title:

The Fetal EKG Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02320279
• Other study ID #: South Shore Fetal EKG study
• Status: Recruiting
• Start date: October 2013
• Est. completion date: December 2023

Study information

• Verified date: November 2021
• Source: Mindchild Medical Inc.
• Contact: Adam Wolfberg, MD
• Phone: 781-624-8000
• Email: adam.wolfberg[@]mindchild.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor

Intervention

Device:
• Fetal Heart Rate Monitor
Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes

Locations

Country	Name	City	State
United States	South Shore Hospital	South Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mindchild Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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