Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497205
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Sponsor:
Biorithm Pte Ltd
Organization:
Biorithm Pte Ltd
Study Overview
Official Title:
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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
The main goal is to learn if the remote recordings using Femom provide reliable information about the babys 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None