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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labour Analgesia
• Intervention / Treatment: Other: Machine-learning prediction model

• Study Type: Observational
• Enrollment (Estimated): 12500

Contacts and Locations

• Study Contact: Name: Bruno A Zanfini, MD; Phone Number: 06 3015 3105; Email: brunoantonio.zanfini@policlinicogemelli.it

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Parturients receiving neuraxial analgesia for labour, as clinical practice

Exclusion Criteria:

• Planned caesarean delivery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Machine-learning algorithm able to predict the LA consumption	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical score	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	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	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	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	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	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	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	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	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	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	To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.	At delivery.
Rate of shoulder dystocia	To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.	At delivery.
Rate of intrapartum caesarean section	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	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	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	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	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	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	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	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	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.	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.	To compare between low- and high-requirement parturients the rate of gestational diabetes.	Throughout pregnancy, up to delivery.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): June 13, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Anesthetics, Local; Machine Learning; Anesthesia, Epidural; Anesthesia, Obstetric
• Other Study ID Numbers: 27389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No