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

22. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

12500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Machine-learning algorithm able to predict the LA consumption
Tidsramme: 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.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

13. juni 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

31. oktober 2026

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 27389

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