NCT06481514

FRI a Method of Reading Cardiotocography (CTG) in Labor

Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of the study is to investigate the FRI's 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.

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.

Conditions

• Labor Complication

Interventions

Type	Name	Description
OTHER	Interpretation of the CTG using FRI score	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. To encourage a simplified clinical interpretation of the different scores obtained (score from 1 to 8) they 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
OTHER	Classic interpretation of the CTG	evaluate the CTG of group B patients according to the usual internal management protocols

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: Italy