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Effect of Epidural Analgesia on Labour, Neonatal and Maternal Outcomes.

NCT05579808 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21808

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • Labor Pain
  • Delivery Complication
  • Regional Anesthesia Morbidity

Interventions

PROCEDURE

Epidural Analgesia

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-07-01
Completion
2021-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579808 on ClinicalTrials.gov