FRI a Method of Reading Cardiotocography (CTG) in Labor (FINIS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Complication
• Intervention / Treatment: Other: Interpretation of the CTG using FRI score; Other: Classic interpretation of the CTG

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.

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela BOTTA; Phone Number: 0630157024; Email: angela.botta@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: Angela Botta; Phone Number: +390630157024; Email: angela.botta@policlinicogemelli.it
    • Principal Investigator: Angela Botta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women in the active phase of labor who presented when they entered the room I delivered a negative admission test (i.e. a normoreactive CTG according to ACOG) and that subsequently present during labor a diagnosis of category II CTG
• Single term pregnancy
• Signature of informed consent

Exclusion criteria

• Failure to sign the informed consent
• Previous caesarean section (TOLAC)
• Twin pregnancy
• Gestational age <37 weeks
• Known genetic/chromosomal syndromes and/or malformations, excluding heart disease without contraindication to vaginal birth

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A (FRI); 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.. 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.	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
Active Comparator: group B (No FRI); The second group of patients will, however, be managed according to the usual protocols internal management.	Other: Classic interpretation of the CTG; evaluate the CTG of group B patients according to the usual internal management protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of cases requiring urgent intervention	number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI	12 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of cases that will present a perinatal outcome adverse events	number of cases that will present a perinatal outcome adverse events (respiratory acidosis, metabolic acidosis, Apgar index, etc.) identified through the application of the FRI compared to the classical interpretation of the CTG.	12 MONTHS

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Angela BOTTA, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications
• Other Study ID Numbers: ID 6566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No