FRI a Method of Reading Cardiotocography (CTG) in Labor

NCT06481514 | Not Yet Recruiting

• 1 other identifier: ID 6566
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of cases that will present a perinatal outcome adverse events

  12 MONTHS

Study Arms (2)

group A (FRI)

ACTIVE COMPARATOR

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

group B (No FRI)

ACTIVE COMPARATOR

The second group of patients will, however, be managed according to the usual protocols internal management.

Other: Classic interpretation of the CTG

Interventions

Interpretation of the CTG using FRI score OTHER

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

group A (FRI)

Classic interpretation of the CTG OTHER

evaluate the CTG of group B patients according to the usual internal management protocols

group B (No FRI)

Eligibility Criteria

• Gender Eligibility Details: the essential criterion is pregnancy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Angela BOTTA

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela BOTTA

CONTACT

0630157024; angela.botta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

IT (1)