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PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous

NCT01856166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2024-05-29

No results posted yet for this study

Summary

Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.

To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.

Conditions

  • Pregnancy

Interventions

DEVICE

Release analgesia by CADD SMITHS PCEA pump

Analgesia will be release by continuous manner with an automatic pump

DEVICE

Release analgesia by CADD SMITHS PIEB pump

Analgesia will be release by bolus with an automatic pump

DRUG

Levobupivacaine

DRUG

Sufentanil

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Estelle MORAU, PhD · CHU Montpellier - Department of gynaecology and obstetric

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • France

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 NCT01856166 on ClinicalTrials.gov