AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies

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

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-19

Study Completion Date

2025-08-31

Brief Summary

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This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.

The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.

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Detailed Description

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The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.

The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.

Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.

Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control Group

low risk ASPRE

No interventions assigned to this group

FGR Group

FGR according to definition of ISUOG

No interventions assigned to this group

Diabetic Group

insulin dependent diabetes

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Singleton live pregnancy
* \> 26 weeks gestational age
* Able to speak English or available NHS interpreter

Exclusion Criteria

* Women below 18 years of age
* Women with an intellectual or mental impairment
* Women with a known allergy or hypersensitivity to ECG gel electrodes
* Known fetal cardiac or genetic abnormality.
* Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
* Inability to access interpreter.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes