Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490471
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Femom System Compared to the Standard of Care CTG
Sponsor:
Biorithm Pte Ltd
Organization:
Biorithm Pte Ltd
Study Overview
Official Title:
A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring
Status:
NOT_YET_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:
The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation 320 weeks of pregnancy The main questions it aims to answer are to assess the agreement between femom data collection FHR MHR UA and values measured via the standard of care used for prenatal monitoring ie CTG The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces
Participants will have the femom device and CTG attached to their abdomen The femom device will be attached for about 30 minutes while they are wearing the device for the NST
Participants will have the femom device and CTG attached to their abdomen The femom device will be attached for about 30 minutes while they are wearing the device for the NST
Detailed Description:
None
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