CardiotocographyNCT04186975
Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy
An observational study of Cardiotocography, run by Rambam Health Care Campus.
Trial summary
The long term aim of this research is to evaluate a portable NI-FECG (Non-invasive fetal ECG) monitor (Holter NI-FECG) which can be used for regular remote assessment of fetal health in pregnancies at risk or to follow-up on treatments. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiotocography
- What is being tested?
- Non-Invasive fetal ECG and Fetal heart rate monitor
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2023
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Low risk and High risk pregnancies. Low risk post date patients. High risk intra uterine growth restricted fetuses.
Who may be able to join
- Singleton pregnancies.
- low-risk pregnancy: women from the post-date clinic (after 40 weeks' gestation) in which we perform routinely Non stress test and ultrasound.
- High-risk pregnancy: women who are hospitalized for different indications: IUGR, diabetes, hypertension, non-reassuring fetal heart rate, Decreased fetal movements
Who cannot join
- Non singleton pregnancies.
- Do not want to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
The long term aim of this research is to evaluate a portable NI-FECG (Non-invasive fetal ECG) monitor (Holter NI-FECG) which can be used for regular remote assessment of fetal health in pregnancies at risk or to follow-up on treatments. The elaboration of a NI-FECG Holter device will offer new opportunities for fetal diagnosis and remote monitoring of problematic pregnancies because of its low-cost, non-invasiveness, portability and minimal set-up requirements.
Read the detailed description
Pregnant patients that are of gestational age in which fetal heart rate monitoring is recommended and feasible will be enrolled to this cohort study. Each patient will be monitored via conventional fetal heart rate monitoring in addition to the NI-FECG method and both methods will be directly compared. Each patient will be her own control. NI-FECG is a non-invasive method of fetal monitoring' thus no ethical issues are relevant. Nevertheless, each patient will sign informed consent before participating in the study.
- Conditions
- Cardiotocography
- Being tested
- Non-Invasive fetal ECG, Fetal heart rate monitor
- Keywords
- FETAL MONITORING, CARDIOTOCOGRAPHY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive fetal ECGDevice
Non-Invasive fetal ECG
Fetal heart rate monitorDevice
Fetal heart rate monitor
| Study group | Role | What they receive |
|---|---|---|
| Low-risk pregnant women | Normal cohort: this cohort consists of pregnancies which are not at risk. Data are recorded during the normal checkup happening as part of the usual care pathway Receives: Device: Non-Invasive fetal ECG; Device: Fetal heart rate monitor | |
| High-risk pregnant women | Risk cohort: this cohort consists of pregnancies at risk and which are regularly recorded for the purpose of fetal surveillance. Specifically, the investigators recruit pregnancies with intra uterine growth restricted fetuses for this study. Receives: Device: Non-Invasive fetal ECG; Device: Fetal heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of abnormal fetal heart rate from NI-FECG
To compare the clinical interpretation of the NI-FECG obtained fetal heart rate trace to the fetal heart rate interpretation from the fetal heart rate obtained from conventional CTG. This will involve blinded reading and scoring of FHR obtained from the NI-FECG and CTG from a panel of expert clinician.
Measured: 2 years
Computerized NI-FECG for the prediction of abnormal FHR traces
To compare the computerized analysis of the FHR trace obtained using NI-FECG to the clinician visual interpretation of the FHR trace obtained using CTG (usual care). This will involve the implementation of algorithms that can detect standard14 and new features assessing the Fetal HRV (FHRV) and the elaboration of a machine learning model which can predict abnormal traces from these features
Measured: 2 years
Comparison between computerized CTG and NI-FECG
To compare the predictive power of computerized CTG versus computerized NI-FECG for the assessment of abnormal traces. For that purpose, a machine learning model will be trained (1) on features extracted from the FHR trace obtained using CTG and (2) on features extracted from the FHR obtained using the NI-FECG trace
Measured: 4 years
Develop a portable NI-FECG monitor for remote fetal monitoring.
To develop a portable NI-FECG monitor which can be used to record the fetal ECG at the patient's home. The monitor will transfer the data to a remote server where source separation will be performed to extract the fetal ECG. Algorithms implemented for extracting characteristic features and the machine learning model will be run to predict whether the traces are normal or abnormal. The elaboration of such algorithm is particularly relevant for resource constrained region where medical experts is scarce.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotocographyStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Oren Grunwald MD, Rambam Health Care Campus
- Investigators
- Oren Grunwald, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186975
- Sponsor's protocol ID
- 0529-19-RMB
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy
- ClinicalTrials.gov ID
- NCT04186975
- Acronym / sponsor ID
- 0529-19-RMB
- Conditions
- Cardiotocography
- Keywords
- FETAL MONITORING, CARDIOTOCOGRAPHY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Dec 2019 (actual)
- 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 long term aim of this research is to evaluate a portable NI-FECG (Non-invasive fetal ECG) monitor (Holter NI-FECG) which can be used for regular remote assessment of fetal health in pregnancies at risk or to follow-up on treatments. The elaboration of a NI-FECG Holter device will offer new opportunities for fetal diagnosis and remote monitoring of problematic pregnancies because of its low-cost, non-invasiveness, portability and minimal set-up requirements.
Detailed description
Pregnant patients that are of gestational age in which fetal heart rate monitoring is recommended and feasible will be enrolled to this cohort study. Each patient will be monitored via conventional fetal heart rate monitoring in addition to the NI-FECG method and both methods will be directly compared. Each patient will be her own control. NI-FECG is a non-invasive method of fetal monitoring' thus no ethical issues are relevant. Nevertheless, each patient will sign informed consent before participating in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-risk pregnant women | – | Device: Non-Invasive fetal ECG, Device: Fetal heart rate monitorNormal cohort: this cohort consists of pregnancies which are not at risk. Data are recorded during the normal checkup happening as part of the usual care pathway |
| High-risk pregnant women | – | Device: Non-Invasive fetal ECG, Device: Fetal heart rate monitorRisk cohort: this cohort consists of pregnancies at risk and which are regularly recorded for the purpose of fetal surveillance. Specifically, the investigators recruit pregnancies with intra uterine growth restricted fetuses for this study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Low risk and High risk pregnancies. Low risk post date patients. High risk intra uterine growth restricted fetuses.
Key inclusion criteria (3 listed)
- Singleton pregnancies.
- low-risk pregnancy: women from the post-date clinic (after 40 weeks' gestation) in which we perform routinely Non stress test and ultrasound.
- High-risk pregnancy: women who are hospitalized for different indications: IUGR, diabetes, hypertension, non-reassuring fetal heart rate, Decreased fetal movements
Key exclusion criteria (2 listed)
- Non singleton pregnancies.
- Do not want to participate in the study
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 |
|---|---|---|
| Non-Invasive fetal ECGNon-Invasive fetal ECG | Device | High-risk pregnant women, Low-risk pregnant women |
| Fetal heart rate monitorFetal heart rate monitor | Device | High-risk pregnant women, Low-risk pregnant women |
Primary outcome
Identification of abnormal fetal heart rate from NI-FECG
Time frame: 2 years
To compare the clinical interpretation of the NI-FECG obtained fetal heart rate trace to the fetal heart rate interpretation from the fetal heart rate obtained from conventional CTG. This will involve blinded reading and scoring of FHR obtained from the NI-FECG and CTG from a panel of expert clinician.
Computerized NI-FECG for the prediction of abnormal FHR traces
Time frame: 2 years
To compare the computerized analysis of the FHR trace obtained using NI-FECG to the clinician visual interpretation of the FHR trace obtained using CTG (usual care). This will involve the implementation of algorithms that can detect standard14 and new features assessing the Fetal HRV (FHRV) and the elaboration of a machine learning model which can predict abnormal traces from these features
Comparison between computerized CTG and NI-FECG
Time frame: 4 years
To compare the predictive power of computerized CTG versus computerized NI-FECG for the assessment of abnormal traces. For that purpose, a machine learning model will be trained (1) on features extracted from the FHR trace obtained using CTG and (2) on features extracted from the FHR obtained using the NI-FECG trace
Develop a portable NI-FECG monitor for remote fetal monitoring.
Time frame: 4 years
To develop a portable NI-FECG monitor which can be used to record the fetal ECG at the patient's home. The monitor will transfer the data to a remote server where source separation will be performed to extract the fetal ECG. Algorithms implemented for extracting characteristic features and the machine learning model will be run to predict whether the traces are normal or abnormal. The elaboration of such algorithm is particularly relevant for resource constrained region where medical experts is scarce.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Oren Grunwald, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotocography, run by Rambam Health Care Campus.
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 3 inclusion and 2 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Oren Grunwald, MD (+972506914415, oren.grunwald@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of abnormal fetal heart rate from NI-FECG (time frame: 2 years). The study lists 4 primary outcomes in all. 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 5 Dec 2019.