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

22 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

12500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • Parturients receiving neuraxial analgesia for labour, as clinical practice

Exclusion Criteria:

  • Planned caesarean delivery

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Machine-learning algorithm able to predict the LA consumption
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At delivery.
To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
At delivery.
Rate of shoulder dystocia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: Throughout pregnancy, up to delivery.
To compare between low- and high-requirement parturients the rate of gestational diabetes.
Throughout pregnancy, up to delivery.

Medewerkers en onderzoekers

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Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

13 juni 2026

Primaire voltooiing (Geschat)

30 september 2026

Studie voltooiing (Geschat)

31 oktober 2026

Studieregistratiedata

Eerst ingediend

8 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

22 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 27389

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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