Labour Analgesia
Conditions
Keywords
Machine Learning, Anesthesia, Obstetric, Anesthesia, Epidural, Anesthetics, Local
Brief 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 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.
Interventions
OTHERMachine-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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parturients receiving neuraxial analgesia for labour, as clinical practice
Exclusion criteria
* Planned caesarean delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Machine-learning algorithm able to predict the LA consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical score | 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". |
| Time-dependent AUC of LA manual boluses | 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) |
| Total LA consumption | From epidural catheter placement to delivery. | To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD) |
| Ratio of time to first bolus demand to duration of labor | 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. |
| Total demand of LA boluses | 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. |
| Total adjunctive rescue LA epidural boluses | 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. |
| Length of active phase | 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). |
| Length of second stage | From full cervical dilation to delivery. | To compare between low- and high-requirement parturients the length of second stage in minutes, mean (+-SD). |
| Rate of postpartum haemorrhage | In the first hour after delivery. | To compare between low- and high-requirement parturients the rate of postpartum haemorrhage, expressed as percentage. |
| Rate of perineal laceration | In the first hour after delivery. | To compare between low- and high-requirement parturients the rate of perineal laceration, expressed as percentage. |
| Rate of episiotomy | At delivery. | To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage. |
| Rate of shoulder dystocia | At delivery. | To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage. |
| Rate of intrapartum caesarean section | 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. |
| Rate of catheter re-siting during labour | 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. |
| Rate of neonatal admission in NICU | 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). |
| Mean Apgar Score at 1 minute | 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. |
| Mean Apgar Score at 5 minutes | 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. |
| Mean Umbilical Cord Arterial pH | 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. |
| Mean Umbilical Cord Venous pH | 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. |
| Mean Umbilical Cord Arterial base excess | 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. |
| Mean Umbilical Cord Venous base excess | 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. |
| The rate of maternal hypertensive disorders. | Throughout pregnancy, up to the first postpartum day. | To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders. |
| The rate of gestational diabetes. | Throughout pregnancy, up to delivery. | To compare between low- and high-requirement parturients the rate of gestational diabetes. |
Countries
Italy
Contacts
CONTACTBruno A Zanfini, MD
Outcome results
None listed