Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia (DIANA)
22. mai 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
12500
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bruno A Zanfini, MD
- Telefonnummer: 06 3015 3105
- E-post: brunoantonio.zanfini@policlinicogemelli.it
Studiesteder
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RM
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Rome, RM, Italia, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion Criteria:
- Planned caesarean delivery
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Machine-learning algorithm able to predict the LA consumption
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
13. juni 2026
Primær fullføring (Antatt)
30. september 2026
Studiet fullført (Antatt)
31. oktober 2026
Datoer for studieregistrering
Først innsendt
8. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 27389
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