Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil (epidarc)

April 28, 2026 updated by: University Hospital, Rouen
The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • centre hospitalier universitaire de Rouen, Hopital Charles Nicolle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years old or more

  • nulliparous

    _ one fetus

  • head first
  • spontaneous labor
  • epidural analgesia
  • no fetal cardiac rhythm abnormalies before the epidural analgesia
  • no active management of labor during 30 minutes after the epidural analgesia induction
  • at term
  • signature of the consent form

Exclusion Criteria:

  • pathological pregnancy
  • low maternal blood pressure during the 30 minutes after the epidural analgesia
  • uterin contraction which last for 5 minutes or more
  • more than 6 uterin contractions during a 10 minutes period
  • Ropivacaine contraindication
  • sufentanil contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: fetal cardiac rhythm abnormally
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
Drug: ropivacaine
Other: control group
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
Drug: ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
Time Frame: 1 day
Maternal Plasmatic concentrations of ropivacaine will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
Time Frame: 1 day
Maternal Plasmatic concentrations of sufentanil will be measured in mg / liter of maternal blood and the median of each group will be compared by paired Wilcoxon test
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimated)

September 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/146/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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