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

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ClinicalTrials.gov Identifier: NCT01686347
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fetal Cardiac Rhythm Abnormalities Drug: ropivacaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Study Start Date : June 2012
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
control group
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
Drug: ropivacaine



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01686347


Locations
France
centre hospitalier universitaire de Rouen, Hopital Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
University Hospital, Rouen

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01686347     History of Changes
Other Study ID Numbers: 2010/146/HP
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by University Hospital, Rouen:
epidural analgesia
fetal cardiac rythm
ropivacaine
sufentanil

Additional relevant MeSH terms:
Ropivacaine
Sufentanil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General