Labor Complication
Conditions
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.
Interventions
OTHERInterpretation 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
OTHERClassic interpretation of the CTG
evaluate the CTG of group B patients according to the usual internal management protocols
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of cases requiring urgent intervention | 12 MONTHS | number of cases requiring urgent intervention (vaginal operative delivery / urgent cesarean section) identified by the FRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of cases that will present a perinatal outcome adverse events | 12 MONTHS | 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. |
Countries
Italy
Contacts
Primary ContactAngela BOTTA
Outcome results
None listed