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 Type
OBSERVATIONAL
Enrollment
12,500
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.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, Italy
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.
Time frame: From the epidural catheter placement to delivery.
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".
Time frame: 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)
Time frame: From epidural catheter placement to delivery.
Total LA consumption
To compare between low- and high-requirement parturients the total LA consumption (mg), mean (+-SD)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: In the first hour after delivery.
Rate of episiotomy
To compare between low- and high-requirement parturients the rate of episiotomy, expressed as percentage.
Time frame: At delivery.
Rate of shoulder dystocia
To compare between low- and high-requirement parturients the rate of shoulder dystocia, expressed as percentage.
Time frame: At delivery.
Rate of intrapartum caesarean section
To compare between low- and high-requirement parturients the rate of intrapartum caesarean section, expressed as percentage.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At delivery.
The rate of maternal hypertensive disorders.
To compare between low- and high-requirement parturients the rate of maternal hypertensive disorders.
Time frame: 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.
Time frame: Throughout pregnancy, up to delivery.
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