Labor ComplicationFINISNCT06481514
FRI a Method of Reading Cardiotocography (CTG) in Labor
A study testing Interpretation of the CTG using FRI score and Classic interpretation of the CTG in people with Labor Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor Complication
- What is being tested?
- Interpretation of the CTG using FRI score and Classic interpretation of the CTG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Angela Botta, +390630157024, angela.botta@policlinicogemelli.it
Angela Botta
About this study
Official title: Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.
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.
Read the 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.
- Conditions
- Labor Complication
- Being tested
- Interpretation of the CTG using FRI score, Classic interpretation of the CTG
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation of the CTG using FRI scoreOther
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 CTGOther
evaluate the CTG of group B patients according to the usual internal management protocols
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Classic interpretation of the CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cases requiring urgent intervention
number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI
Measured: 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.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela BOTTA, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481514
- Sponsor's protocol ID
- ID 6566
- Acronym
- FINIS
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.
- ClinicalTrials.gov ID
- NCT06481514
- Acronym / sponsor ID
- FINIS / ID 6566
- Conditions
- Labor Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (FRI) | Active comparator | Other: Interpretation of the CTG using FRI scoreThe "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. |
| group B (No FRI) | Active comparator | Other: Classic interpretation of the CTGThe second group of patients will, however, be managed according to the usual protocols internal management. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpretation of the CTG using FRI scoreAt 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 | Other | group A (FRI) |
| Classic interpretation of the CTGevaluate the CTG of group B patients according to the usual internal management protocols | Other | group B (No FRI) |
Primary outcome
number of cases requiring urgent intervention
Time frame: 12 MONTHS
number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI
1 secondary outcome
number of cases that will present a perinatal outcome adverse events
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela BOTTA principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation of the CTG using FRI score and Classic interpretation of the CTG in people with Labor Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela BOTTA (0630157024, angela.botta@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cases requiring urgent intervention (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.