Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)
22 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
12500
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Bruno A Zanfini, MD
- Telefonnummer: 06 3015 3105
- E-post: brunoantonio.zanfini@policlinicogemelli.it
Studieorter
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RM
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Rome, RM, Italien, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion Criteria:
- Planned caesarean delivery
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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).
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Machine-learning algorithm able to predict the LA consumption
Tidsram: From the epidural catheter placement to delivery.
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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.
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From the epidural catheter placement to delivery.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinical score
Tidsram: At admission in the Labour Suite and before the epidural catheter is placed
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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".
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At admission in the Labour Suite and before the epidural catheter is placed
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Time-dependent AUC of LA manual boluses
Tidsram: From epidural catheter placement to delivery.
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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)
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From epidural catheter placement to delivery.
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Total LA consumption
Tidsram: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
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From epidural catheter placement to delivery.
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Ratio of time to first bolus demand to duration of labor
Tidsram: From epidural catheter placement to delivery.
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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.
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From epidural catheter placement to delivery.
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Total demand of LA boluses
Tidsram: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total demand of LA boluses, mean (+-SD), in case of analgesia maintenance through top-up.
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From epidural catheter placement to delivery.
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Total adjunctive rescue LA epidural boluses
Tidsram: From epidural catheter placement to delivery.
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To compare between low- and high-requirement parturients the total adjunctive rescue LA epidural boluses, mean (+-SD), in case of analgesia maintenance through PIEB.
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From epidural catheter placement to delivery.
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Length of active phase
Tidsram: From start of the active phase to full cervical dilation, up to 24 hours.
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To compare between low- and high-requirement parturients the length of active phase in minutes, mean (+-SD).
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From start of the active phase to full cervical dilation, up to 24 hours.
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Length of second stage
Tidsram: From full cervical dilation to delivery.
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To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD).
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From full cervical dilation to delivery.
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Rate of postpartum haemorrhage
Tidsram: In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage.
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In the first hour after delivery.
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Rate of perineal laceration
Tidsram: In the first hour after delivery.
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To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage.
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In the first hour after delivery.
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Rate of episiotomy
Tidsram: At delivery.
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To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
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At delivery.
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Rate of shoulder dystocia
Tidsram: At delivery.
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To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
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At delivery.
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Rate of intrapartum caesarean section
Tidsram: From admission to the Labour suite to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
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From admission to the Labour suite to delivery, up to 24 hours.
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Rate of catheter re-siting during labour
Tidsram: From the placement of the first epidural catheter to delivery, up to 24 hours.
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To compare between low- and high-requirement parturients the rate of catheter re-siting during labour, expressed as percentage.
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From the placement of the first epidural catheter to delivery, up to 24 hours.
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Rate of neonatal admission in NICU
Tidsram: After delivery, up to 1 hour.
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To compare between low- and high-requirement parturients the rate of neonatal admission in Neonatal Intensive Care Unit (NICU).
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After delivery, up to 1 hour.
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Mean Apgar Score at 1 minute
Tidsram: 1 minute after delivery.
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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.
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1 minute after delivery.
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Mean Apgar Score at 5 minutes
Tidsram: 5 minutes after delivery.
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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.
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5 minutes after delivery.
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Mean Umbilical Cord Arterial pH
Tidsram: At delivery.
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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.
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At delivery.
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Mean Umbilical Cord Venous pH
Tidsram: At delivery.
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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.
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At delivery.
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Mean Umbilical Cord Arterial base excess
Tidsram: At delivery.
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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.
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At delivery.
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Mean Umbilical Cord Venous base excess
Tidsram: At delivery.
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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.
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At delivery.
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The rate of maternal hypertensive disorders.
Tidsram: Throughout pregnancy, up to the first postpartum day.
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To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
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Throughout pregnancy, up to the first postpartum day.
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The rate of gestational diabetes.
Tidsram: Throughout pregnancy, up to delivery.
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To compare between low- and high-requirement parturients the rate of gestational diabetes.
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Throughout pregnancy, up to delivery.
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
13 juni 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
31 oktober 2026
Studieregistreringsdatum
Först inskickad
8 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2026
Senast verifierad
1 maj 2026
Mer information
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Andra studie-ID-nummer
- 27389
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