LaborNCT02320279
The Fetal EKG Study
An observational study of Labor, run by Mindchild Medical Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor
- What is being tested?
- Fetal Heart Rate Monitor
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
South Shore Hospital
South Weymouth, Massachusetts, 02190
Adam Wolfberg, MD
About this 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.
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.
- Conditions
- Labor
- Being tested
- Fetal Heart Rate Monitor
- Keywords
- Fetal Heart Rate, Fetal EKG, FHR tracing, fetal R-waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Heart Rate MonitorDevice
Also called Mindchild Meridian Fetal Heart Rate System
Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fetal Heart Rate Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mindchild Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Wolfberg, MD, Principal investigator, South Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320279
- Sponsor's protocol ID
- South Shore Fetal EKG study
- Status last verified
- Nov 2021
- First submitted
- 16 Dec 2014
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fetal EKG Study
- ClinicalTrials.gov ID
- NCT02320279
- Acronym / sponsor ID
- South Shore Fetal EKG study
- Conditions
- Labor
- Keywords
- Fetal Heart Rate, Fetal EKG, FHR tracing, fetal R-waves
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Mindchild Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in labor | – | Device: Fetal Heart Rate MonitorPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Heart Rate MonitorAlso: Mindchild Meridian Fetal Heart Rate SystemUse of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes | Device | Women in labor |
Primary outcome
Quantitative FHR
Time frame: 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.
1 secondary outcome
Uterine contractions
Time frame: During labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Wolfberg, MD principal investigator
South Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor, run by Mindchild Medical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Wolfberg, MD (781-624-8000, adam.wolfberg@mindchild.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative FHR (time frame: During Labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.