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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02320279
Other study ID # South Shore Fetal EKG study
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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