NCT04186975

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Non-Invasive fetal ECG	Non-Invasive fetal ECG
DEVICE	Fetal heart rate monitor	Fetal heart rate monitor

Timeline

• Start date: 2019-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-12-05
• Last updated: 2019-12-05