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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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

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Cardiotocography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Non-Invasive fetal ECG

Intervention Type DEVICE

Non-Invasive fetal ECG

Fetal heart rate monitor

Intervention Type 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.

Non-Invasive fetal ECG

Intervention Type DEVICE

Non-Invasive fetal ECG

Fetal heart rate monitor

Intervention Type DEVICE

Fetal heart rate monitor

Interventions

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Non-Invasive fetal ECG

Intervention Type DEVICE

Fetal heart rate monitor

Intervention Type DEVICE

Eligibility Criteria

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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