Clinical trial NCT06481514: FRI a Method of Reading Cardiotocography (CTG) in Labor
Official title: Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Labor Complication
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 290
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: number of cases requiring urgent intervention
timeFrame: 12 MONTHS
Secondary outcomes:
measure: number of cases that will present a perinatal outcome adverse events
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Angela BOTTA
role: PRINCIPAL_INVESTIGATOR
References: