FRI a Method of Reading Cardiotocography (CTG) in Labor

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Interpretation of the CTG using FRI score

    Other intervention

    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

    Other intervention

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

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: group A (FRI)Active comparator 1 intervention
Group B: group B (No FRI)Active comparator 1 intervention

Trial outcomes

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

Time frame
12 MONTHS

Secondary outcomes

1

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.

Time frame
12 MONTHS

Other outcomes

Sponsors and contacts

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