Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy

NCT04186975 | Unknown

• 1 other identifier: 0529-19-RMB
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cardiotocography

Keywords

FETAL MONITORING, CARDIOTOCOGRAPHY

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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.

  4 years

Study Arms (2)

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

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.

Device: Non-Invasive fetal ECG; Device: Fetal heart rate monitor

Interventions

Non-Invasive fetal ECG DEVICE

Non-Invasive fetal ECG

High-risk pregnant women; Low-risk pregnant women

Fetal heart rate monitor DEVICE

Fetal heart rate monitor

High-risk pregnant women; Low-risk pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Low risk and High risk pregnancies. Low risk post date patients. High risk intra uterine growth restricted fetuses.

You may qualify if:

• 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

You may not qualify if:

• Non singleton pregnancies.
• Do not want to participate in the study

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Technion, Israel Institute of Technology: collaborator

Study Officials

• Oren Grunwald, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Grunwald, MD

CONTACT

+972506914415; oren.grunwald@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oren Grunwald MD

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share