AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies

Biorithm

Status

Enrolling

Conditions

Pregnancy Related

Study type

Observational

Funder types

Industry

Identifiers

NCT06497205

AMBER2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.