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NCT Number: NCT07614516

Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia

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.

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Key information

Conditions

Labour Analgesia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturients receiving neuraxial analgesia for labour, as clinical practice

Exclusion criteria

  • Planned caesarean delivery

Treatment and study plan

Machine-learning prediction model

Other

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.

Primary outcomes

  1. Machine-learning algorithm able to predict the LA consumption

    Time frame: 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.

Secondary outcomes

  1. Clinical score

    Time frame: 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".

  2. Time-dependent AUC of LA manual boluses

    Time frame: 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)

  3. Total LA consumption

    Time frame: From epidural catheter placement to delivery.

    To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)

  4. Ratio of time to first bolus demand to duration of labor

    Time frame: 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.

  5. Total demand of LA boluses

    Time frame: 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.

  6. Total adjunctive rescue LA epidural boluses

    Time frame: 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.

  7. Length of active phase

    Time frame: 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).

  8. Length of second stage

    Time frame: From full cervical dilation to delivery.

    To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD).

  9. Rate of postpartum haemorrhage

    Time frame: In the first hour after delivery.

    To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage.

  10. Rate of perineal laceration

    Time frame: In the first hour after delivery.

    To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage.

  11. Rate of episiotomy

    Time frame: At delivery.

    To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.

  12. Rate of shoulder dystocia

    Time frame: At delivery.

    To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.

  13. Rate of intrapartum caesarean section

    Time frame: 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.

  14. Rate of catheter re-siting during labour

    Time frame: 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.

  15. Rate of neonatal admission in NICU

    Time frame: 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).

  16. Mean Apgar Score at 1 minute

    Time frame: 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.

  17. Mean Apgar Score at 5 minutes

    Time frame: 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.

  18. Mean Umbilical Cord Arterial pH

    Time frame: 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.

  19. Mean Umbilical Cord Venous pH

    Time frame: 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.

  20. Mean Umbilical Cord Arterial base excess

    Time frame: 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.

  21. Mean Umbilical Cord Venous base excess

    Time frame: 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.

  22. The rate of maternal hypertensive disorders.

    Time frame: Throughout pregnancy, up to the first postpartum day.

    To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.

  23. The rate of gestational diabetes.

    Time frame: Throughout pregnancy, up to delivery.

    To compare between low- and high-requirement parturients the rate of gestational diabetes.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno A Zanfini, MD

CONTACT

[email protected]

06 3015 3105

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.

Acronym: DIANA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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