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FRI a Method of Reading Cardiotocography (CTG) in Labor
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2024-07
Completion Date
2025-12
Last Updated
2024-07-01
Healthy Volunteers
No
Conditions
Interventions
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
Classic interpretation of the CTG
evaluate the CTG of group B patients according to the usual internal management protocols
Locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy