Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481514
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
FRI a Method of Reading Cardiotocography CTG in Labor
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Fetal Reserve Index FRI as a Tool for Improving Surveillance Cardiotocography in Labor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
FINIS
Brief Summary:
The objective of the study is to investigate the FRIs ability to identify cases requiring urgent intervention which will present an adverse perinatal outcome respiratory acidosis metabolic acidosis Apgar index etc compared to the classical interpretation of CTG
Patients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups The Fetal Reserve Index algorithm will be applied to the first group of patients
The second group of patients will however be managed according to the usual protocols internal management
Patients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups The Fetal Reserve Index algorithm will be applied to the first group of patients
The second group of patients will however be managed according to the usual protocols internal management
Detailed Description:
Patients in active labor and diagnosed with category II CTG will be enrolled and randomized into two groups Full randomization will be performed by Excel software by generating random numbers using the Randomise RAND function The Fetal Reserve Index algorithm will be applied to the first group of patients In in these patients the fetal reserve index will be calculated every 10 minutes At each of the components of the score will be assigned a score of 1 if the variable evaluated is considered normal 0 if classified as abnormal The different scores obtained score from 1 to 8 will be classified into 3 risk categories Score 5-8 green zone Score 3-4 zone yellow Score 1-2 red zone An FRI of 1-2 red zone is to be considered as anomalous For patients with abnormal FRI a 40 minute timer will be started within which it will be necessary to exit the red zone If such patients will not be able to exit the red zone within 40 minutes an additional timer will be started of 30 minutes within which the birth will be completed The birth will be completed immediately in case of sentinel events prolonged bradycardia detachment of placenta cord prolapse
The second group of patients will however be managed according to the usual protocols internal management
The second group of patients will however be managed according to the usual protocols internal management
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