AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Biorithm Pte Ltd
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- FHR
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
FHR
Time Frame: 60 minutes
FHR agreement between Femom system and standard of care (CTG)
MHR
Time Frame: 60 minutes
MHR agreement between Femom system and standard of care (CTG)
Secondary Outcomes
No secondary outcomes reported