AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
1 other identifier
observational
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2024
CompletedFirst Submitted
Initial submission to the registry
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedJuly 11, 2024
July 1, 2024
1.1 years
July 4, 2024
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
FHR
FHR agreement between Femom system and standard of care (CTG)
60 minutes
MHR
MHR agreement between Femom system and standard of care (CTG)
60 minutes
Study Arms (3)
Control Group
low risk ASPRE
FGR Group
FGR according to definition of ISUOG
Diabetic Group
insulin dependent diabetes
Eligibility Criteria
Women booked for antenatal care at St. George's hospital or women under the care of the Fetal medicine unit at St. George's hospital will be invited to participate in this study.
You may qualify if:
- Singleton live pregnancy
- \> 26 weeks gestational age
- Able to speak English or available NHS interpreter
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biorithm Pte Ltdlead
Study Sites (1)
St Georges University Hospital
London, Tooting, SW17 0QT, United Kingdom
Related Publications (1)
Pegorie C, Liu B, Thilaganathan B, Bhide A. Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol. BMJ Open. 2025 Sep 28;15(9):e096123. doi: 10.1136/bmjopen-2024-096123.
PMID: 41022451DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Amarnath Bhide, MBBS, PHD
St Georges University Hospitals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2024
First Posted
July 11, 2024
Study Start
March 19, 2024
Primary Completion
April 30, 2025
Study Completion
August 31, 2025
Last Updated
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share