Labour AnalgesiaDIANANCT07614516
Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia
An observational study of Labour Analgesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- Machine-learning prediction model
- How many people
- 12,500 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jun 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Who cannot join
- Planned caesarean delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
About this study
Official title: 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.
- Conditions
- Labour Analgesia
- Being tested
- Machine-learning prediction model
- Keywords
- Machine Learning, Anesthesia, Obstetric, Anesthesia, Epidural, Anesthetics, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine-learning prediction modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Machine-learning prediction model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the epidural catheter placement to delivery.
Secondary outcomes (23)
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".
Measured: 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)
Measured: From epidural catheter placement to delivery.
Total LA consumption
To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: In the first hour after delivery.
Rate of episiotomy
To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
Measured: At delivery.
Rate of shoulder dystocia
To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
Measured: At delivery.
Rate of intrapartum caesarean section
To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At delivery.
The rate of maternal hypertensive disorders.
To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
Measured: 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.
Measured: Throughout pregnancy, up to delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start13 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour AnalgesiaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZANFINI BRUNO ANTONIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614516
- Sponsor's protocol ID
- 27389
- Acronym
- DIANA
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Local Anaesthetic Dosing During Labour Epidural Analgesia: a Machine-learning Approach. The DIANA (Dosing Intrapartum ANAesthetics) Study.
- ClinicalTrials.gov ID
- NCT07614516
- Acronym / sponsor ID
- DIANA / 27389
- Conditions
- Labour Analgesia
- Keywords
- Machine Learning, Anesthesia, Obstetric, Anesthesia, Epidural, Anesthetics, Local
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All parturients between January 2020 and March 2026 | – | Other: Machine-learning prediction modelAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Parturients receiving neuraxial analgesia for labour, as clinical practice
Key exclusion criteria (1 listed)
- Planned caesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine-learning prediction modelA 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. | Other | All parturients between January 2020 and March 2026 |
Primary outcome
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.
23 secondary outcomes
Clinical score
Time frame: At admission in the Labour Suite and before the epidural catheter is placed
Time-dependent AUC of LA manual boluses
Time frame: From epidural catheter placement to delivery.
Total LA consumption
Time frame: From epidural catheter placement to delivery.
Ratio of time to first bolus demand to duration of labor
Time frame: From epidural catheter placement to delivery.
Total demand of LA boluses
Time frame: From epidural catheter placement to delivery.
Total adjunctive rescue LA epidural boluses
Time frame: From epidural catheter placement to delivery.
Length of active phase
Time frame: From start of the active phase to full cervical dilation, up to 24 hours.
Length of second stage
Time frame: From full cervical dilation to delivery.
Rate of postpartum haemorrhage
Time frame: In the first hour after delivery.
Rate of perineal laceration
Time frame: In the first hour after delivery.
Rate of episiotomy
Time frame: At delivery.
Rate of shoulder dystocia
Time frame: At delivery.
Rate of intrapartum caesarean section
Time frame: From admission to the Labour suite to delivery, up to 24 hours.
Rate of catheter re-siting during labour
Time frame: From the placement of the first epidural catheter to delivery, up to 24 hours.
Rate of neonatal admission in NICU
Time frame: After delivery, up to 1 hour.
Mean Apgar Score at 1 minute
Time frame: 1 minute after delivery.
Mean Apgar Score at 5 minutes
Time frame: 5 minutes after delivery.
Mean Umbilical Cord Arterial pH
Time frame: At delivery.
Mean Umbilical Cord Venous pH
Time frame: At delivery.
Mean Umbilical Cord Arterial base excess
Time frame: At delivery.
Mean Umbilical Cord Venous base excess
Time frame: At delivery.
The rate of maternal hypertensive disorders.
Time frame: Throughout pregnancy, up to the first postpartum day.
The rate of gestational diabetes.
Time frame: Throughout pregnancy, up to delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Labour Analgesia
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruitingObservational study
Machine Learning to Predict Fever After Labor Analgesia
Intrapartum Fever
Not yet recruitingObservational study
Maternal Glucose, Cortisol, and Neonatal Outcomes With and Without GDM
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labour Analgesia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno A Zanfini, MD (06 3015 3105, brunoantonio.zanfini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine-learning algorithm able to predict the LA consumption (time frame: From the epidural catheter placement to delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.