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

Rambam Health Care Campus

Status: Unknown

Conditions: Cardiotocography

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

Study type: Observational

Funder types: Other

Identifiers

NCT04186975

0529-19-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Low-risk pregnant women

Description:

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

Treatment:

Device: Non-Invasive fetal ECG

Device: Fetal heart rate monitor

High-risk pregnant women

Description:

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.

Treatment:

Device: Non-Invasive fetal ECG

Device: Fetal heart rate monitor