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Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)

22 maggio 2026 aggiornato da: ZANFINI BRUNO ANTONIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.

Epidural analgesia is the gold standard for controlling labour pain. However, labour pain happens during neuraxial analgesia, due to anaesthetic, obstetric, maternal factors.

The investigators hypothesized that relevant variables, able to predict the local anaesthetic (LA) requirement during labour, can be identified at admission and each parturient may therefore be accordingly classified in "low-requirement" and "high-requirement". In this way, a predictive score may be developed, and the analgesic regimen may be matched to the individual patient, thus ensuring a timely and appropriate treatment of patients likely to require higher doses of LA, while minimizing potentially side effects of excessive treatment in the low-dose group.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

12500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Italia
    • RM
      • Rome, RM, Italia, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria.

Descrizione

Inclusion Criteria:

  • Parturients receiving neuraxial analgesia for labour, as clinical practice

Exclusion Criteria:

  • Planned caesarean delivery

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
All parturients between January 2020 and March 2026
All parturients who delivered via vaginal route or intrapartum caesarean section and received neuraxial analgesia (epidural analgesia (EA) or combined spinal-epidural [CSE] analgesia or dural puncture epidural (DPE)) in Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, between January 1st, 2020 and March 01th, 2026 (including follow-up data), meeting the inclusion criteria. Labour analgesia was maintained through manual top-up boluses or PIEB (Programmed Intermittent Epidural Bolus).
Altro: Machine-learning prediction model
A machine-learning prediction model will be developed to anticipate the parturient's requirement of LA at admission in the Labour Suite, according to demographic, obstetric and anaesthetic features ongoing before administration of the first epidural bolus.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Machine-learning algorithm able to predict the LA consumption
Lasso di tempo: From the epidural catheter placement to delivery.
To develop a machine-learning algorithm able to predict the mean hourly cumulative LA consumption administered via the epidural catheter from the catheter placement up to delivery, expressed as time-weighted LA consumption per hour (mg/h) in patients receiving top-up analgesia or the need for adjunctive rescue LA boluses in patients receiving PIEB (Programmed Intermittent Epidural Bolus) analgesia.
From the epidural catheter placement to delivery.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical score
Lasso di tempo: At admission in the Labour Suite and before the epidural catheter is placed
To develop a clinical score, based on the machine learning algorithm, with the aim of predicting the patient's LA requirement at admission, thus categorizing parturients as "low requirement" or "high requirement".
At admission in the Labour Suite and before the epidural catheter is placed
Time-dependent AUC of LA manual boluses
Lasso di tempo: From epidural catheter placement to delivery.
To compare (between low- and high-requirement parturients) the time-dependent AUC of LA boluses (in case of analgesia maintenance through top-up) and the time-dependent AUC of adjunctive rescue LA boluses (in case of analgesia maintenance through PIEB)
From epidural catheter placement to delivery.
Total LA consumption
Lasso di tempo: From epidural catheter placement to delivery.
To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
From epidural catheter placement to delivery.
Ratio of time to first bolus demand to duration of labor
Lasso di tempo: From epidural catheter placement to delivery.
To compare between low- and high-requirement parturients the ratio of time to first bolus demand to duration of labor (%), mean (+-SD), in case of analgesia maintenance through top-up.
From epidural catheter placement to delivery.
Total demand of LA boluses
Lasso di tempo: From epidural catheter placement to delivery.
To compare between low- and high-requirement parturients the total demand of LA boluses, mean (+-SD), in case of analgesia maintenance through top-up.
From epidural catheter placement to delivery.
Total adjunctive rescue LA epidural boluses
Lasso di tempo: From epidural catheter placement to delivery.
To compare between low- and high-requirement parturients the total adjunctive rescue LA epidural boluses, mean (+-SD), in case of analgesia maintenance through PIEB.
From epidural catheter placement to delivery.
Length of active phase
Lasso di tempo: From start of the active phase to full cervical dilation, up to 24 hours.
To compare between low- and high-requirement parturients the length of active phase in minutes, mean (+-SD).
From start of the active phase to full cervical dilation, up to 24 hours.
Length of second stage
Lasso di tempo: From full cervical dilation to delivery.
To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD).
From full cervical dilation to delivery.
Rate of postpartum haemorrhage
Lasso di tempo: In the first hour after delivery.
To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage.
In the first hour after delivery.
Rate of perineal laceration
Lasso di tempo: In the first hour after delivery.
To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage.
In the first hour after delivery.
Rate of episiotomy
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
At delivery.
Rate of shoulder dystocia
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
At delivery.
Rate of intrapartum caesarean section
Lasso di tempo: From admission to the Labour suite to delivery, up to 24 hours.
To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
From admission to the Labour suite to delivery, up to 24 hours.
Rate of catheter re-siting during labour
Lasso di tempo: From the placement of the first epidural catheter to delivery, up to 24 hours.
To compare between low- and high-requirement parturients the rate of catheter re-siting during labour, expressed as percentage.
From the placement of the first epidural catheter to delivery, up to 24 hours.
Rate of neonatal admission in NICU
Lasso di tempo: After delivery, up to 1 hour.
To compare between low- and high-requirement parturients the rate of neonatal admission in Neonatal Intensive Care Unit (NICU).
After delivery, up to 1 hour.
Mean Apgar Score at 1 minute
Lasso di tempo: 1 minute after delivery.
To compare between low- and high-requirement parturients the neonatal Apgar score at 1 minute, expressed as mean +- DS. The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration. Each category is assigned a score of 0, 1 or 2.
1 minute after delivery.
Mean Apgar Score at 5 minutes
Lasso di tempo: 5 minutes after delivery.
To compare between low- and high-requirement parturients the neonatal Apgar score at 5 minutes, expressed as mean +- DS. The Apgar score is a 10-point evaluation scoring system used to assess a newborn's health immediately after birth, based on 5 criteria: Appearance, Pulse, Grimace, Activity, and Respiration. Each category is assigned a score of 0, 1 or 2.
5 minutes after delivery.
Mean Umbilical Cord Arterial pH
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the umbilical cord arterial pH, expressed as mean +- DS. Reference ranges of cord arterial pH is 7.2 - 7.4.
At delivery.
Mean Umbilical Cord Venous pH
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the umbilical cord venous pH, expressed as mean +- DS. Reference ranges of cord venous pH is 7.25 - 7.45.
At delivery.
Mean Umbilical Cord Arterial base excess
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the umbilical cord arterial base excess, expressed as mean +- DS. Reference ranges of cord arterial base excess is -9 to +2.
At delivery.
Mean Umbilical Cord Venous base excess
Lasso di tempo: At delivery.
To compare between low- and high-requirement parturients the umbilical cord venous base excess, expressed as mean +- DS. Reference ranges of cord venous base excess is -10 to +0.
At delivery.
The rate of maternal hypertensive disorders.
Lasso di tempo: Throughout pregnancy, up to the first postpartum day.
To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
Throughout pregnancy, up to the first postpartum day.
The rate of gestational diabetes.
Lasso di tempo: Throughout pregnancy, up to delivery.
To compare between low- and high-requirement parturients the rate of gestational diabetes.
Throughout pregnancy, up to delivery.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

13 giugno 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

31 ottobre 2026

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 27389

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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