Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)
22. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Odhadovaný)
12500
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Bruno A Zanfini, MD
- Telefonní číslo: 06 3015 3105
- E-mail: brunoantonio.zanfini@policlinicogemelli.it
Studijní místa
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RM
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Rome, RM, Itálie, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
Inclusion Criteria:
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion Criteria:
- Planned caesarean delivery
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Machine-learning algorithm able to predict the LA consumption
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
13. června 2026
Primární dokončení (Odhadovaný)
30. září 2026
Dokončení studie (Odhadovaný)
31. října 2026
Termíny zápisu do studia
První předloženo
8. května 2026
První předloženo, které splnilo kritéria kontroly kvality
22. května 2026
První zveřejněno (Aktuální)
29. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 27389
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