CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21,808 enrolled
Drug / intervention
Epidural Analgesiaprocedure
Likely dose
Not stated in record
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Search/NCT05579808
NCT05579808N/ACompleted

The Effect of Epidural Analgesia on Labour and Neonatal and Maternal Outcomes in 1, 2a, 3, and 4a Robson's Classes: a Propensity Score-matched Analysis

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted Oct 14, 2022·Updated Oct 14, 2022

In Brief

An observational study evaluating Epidural Analgesia for Labor Pain and 2 related conditions. Completed, enrolled 21,808 participants across 1 site.

Detailed Summary

Lumbar epidural analgesia is the most used method for reducing labour pain, but its impact on the duration of the second stage of labour and on neonatal and maternal outcomes remains debated. The aim was of the study is to examine whether epidural analgesia affects the course and the outcomes of labour among patients divided according to the Robson-10 group classification system. Patients of Robson's classes 1, 2a, 3, and 4a were divided into either the epidural analgesia group or the non-epidural analgesia group. A propensity score matching analysis was performed to balance intergroup differences. The primary goal was to analyse the duration of the second stage of labour. The secondary goals were to evaluate neonatal and maternal outcomes.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 14, 2022
Enrollment StartJun 1, 2021
Primary CompletionJul 1, 2021
Study CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.7 years ago

Interventions

Epidural Analgesiaprocedure

Using an aseptic technique while the patient is in sitting position, an epidural catheter was placed at the L2-L3 or L3-L4 interspace. Analgesia was established with the epidural administration of a low dose of local anaesthetic, plus a lipid-soluble opioid (ropivacaine 0.1% and sufentanyl 0.5%, 20 mL). Analgesia was maintained with a top-up regimen, using intermittent manual epidural boluses of increasing concentrations of ropivacaine, with up to 0.15% at full dilation, according to specific needs of individual participants.