About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Failure to sign the informed consent
Previous caesarean section (TOLAC)
Twin pregnancy
Gestational age <37 weeks
Trial design
Parallel
Treatments tested in this trial
Interpretation of the CTG using FRI score
Other interventionAt 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
Other interventionevaluate the CTG of group B patients according to the usual internal management protocols
Treatment groups
Trial outcomes
Primary outcomes
number of cases requiring urgent intervention
number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI
Secondary outcomes
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: