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

22 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

12500

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

  • Parturients receiving neuraxial analgesia for labour, as clinical practice

Exclusion Criteria:

  • Planned caesarean delivery

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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).
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Machine-learning algorithm able to predict the LA consumption
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Clinical score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At delivery.
To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
At delivery.
Rate of shoulder dystocia
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: Throughout pregnancy, up to delivery.
To compare between low- and high-requirement parturients the rate of gestational diabetes.
Throughout pregnancy, up to delivery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

13 czerwca 2026

Zakończenie podstawowe (Szacowany)

30 września 2026

Ukończenie studiów (Szacowany)

31 października 2026

Daty rejestracji na studia

Pierwszy przesłany

8 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2026

Pierwszy wysłany (Rzeczywisty)

29 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 27389

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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