CClinicalTrials.gg
Status unknownNCT02320279Updated Nov 16, 2021

The Fetal EKG Study

An observational study in Labor, sponsored by Mindchild Medical Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.

Sponsored by Mindchild Medical Inc. · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Labor

Keywords

  • Fetal Heart Rate
  • Fetal EKG
  • FHR tracing
  • fetal R-waves
03

In context

Lead sponsor

Mindchild Medical Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • DeviceFetal Heart Rate Monitor

    Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes

    Also known as: Mindchild Meridian Fetal Heart Rate System

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During Labor

Secondary outcomes

  1. 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.

    Time frame: During labor

07

Study locations

1 of 1 sites recruiting
  • South Shore Hospital
    South Weymouth, Massachusetts 02190, United States
    • Adam Wolfberg, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02320279
Lead sponsor
Mindchild Medical Inc.
Responsible party
Sponsor
First posted
Dec 19, 2014
Start date
Oct 2013
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Nov 16, 2021

Study contacts

Adam Wolfberg, MD
Contact
adam.wolfberg@mindchild.com
781-624-8000
Adam Wolfberg, MD
principal investigator · South Shore Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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