NCT01856166

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

April 29, 2013

Last Update Submit

May 27, 2024

Conditions

Pregnancy

Keywords

NulliparousSingletondeliverypregnancy

Outcome Measures

Primary Outcomes (1)

  • Occurence of a specific clinical criteria which can lead to a complication of the delivery

    Specific clinical criteria are: * Type of posterior engagement * Type of posterior extrication * Duration of waiting at complete dilatation \> 3 hours * Duration of expulsive efforts \> 40 minutes * Foetal bradycardia \< 100 BPM during 1 minute at least

    Up to 10 hours

Secondary Outcomes (5)

  • Instrumental delivery rate

    up to 10 hours

  • Pain during the end of labor

    up to 10 hours

  • Efficacity of epidural analgesia

    up to 10 hours

  • Efficacity of epidural analgesia

    up to 10 hours

  • Presence of motor block

    Up to 10 hours

Study Arms (2)

CEI-PCEA

ACTIVE COMPARATOR

Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia

Device: Release analgesia by CADD SMITHS PCEA pumpDrug: LevobupivacaineDrug: Sufentanil

PIEB-PCEA

EXPERIMENTAL

Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia

Device: Release analgesia by CADD SMITHS PIEB pumpDrug: LevobupivacaineDrug: Sufentanil

Interventions

Release analgesia by CADD SMITHS PCEA pumpDEVICE

Analgesia will be release by continuous manner with an automatic pump

CEI-PCEA
Release analgesia by CADD SMITHS PIEB pumpDEVICE

Analgesia will be release by bolus with an automatic pump

PIEB-PCEA
LevobupivacaineDRUG
CEI-PCEAPIEB-PCEA
SufentanilDRUG
CEI-PCEAPIEB-PCEA

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension \<4cm and eligible for an epidural analgesia
  • Patient has signed informed consent
  • Patient affiliated or beneficiary of a social medical insurance
  • Patient aged between 18 and 44 years old

You may not qualify if:

  • Morphinic administration before the care
  • Anomaly of fetal cardiac rate
  • Fetal or maternal anomalies wich don't allow to evaluate motor block
  • Known uterine malformation
  • Contraindications for thrusts for pregnancy
  • Patient protected by law
  • Patient under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Mère Enfant

Bron, 69500, France

Location

CHU d'Estaing

Clermont-Ferrand, 63003, France

Location

CHU Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

CHU of Montpellier

Montpellier, 34000, France

Location

Related Publications (1)

  • Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.

    PMID: 31335447DERIVED

MeSH Terms

Interventions

LevobupivacaineSufentanil

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Estelle MORAU, PhD

    CHU Montpellier - Department of gynaecology and obstetric

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2013

First Posted

May 17, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

FR(4)