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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiotocography
• Intervention / Treatment: Device: Non-Invasive fetal ECG; Device: Fetal heart rate monitor

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Oren Grunwald, MD; Phone Number: +972506914415; Email: oren.grunwald@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-Invasive fetal ECG; Device: Fetal heart rate monitor; 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; Non-Invasive fetal ECG; Device: Fetal heart rate monitor; Fetal heart rate monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Technion, Israel Institute of Technology
• Investigators: Principal Investigator: Oren Grunwald, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: FETAL MONITORING, CARDIOTOCOGRAPHY
• Other Study ID Numbers: 0529-19-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No