Text Size

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

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01686347
First received: June 7, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Fetal Cardiac Rhythm Abnormalities

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   None Retained

maternal blood, umbilical cord blood and neonatal urine


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
fetal cardiac rhythm abnormally
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
control group
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

nulliparous women at term, in spontaneous labor with an epidural analgésia

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686347

Contacts
Contact: PIZZAGALLI franck, midwife +33232888990 ext 64286 franck.pizzagali@chu-rouen.fr

Locations
France
centre hospitalier universitaire de Rouen, Hopital Charles Nicolle Recruiting
Rouen, France, 76000
Contact: pizzagalli franck, widwife     0232888990 ext 64286     franck.pizzagali@chu-rouen.fr    
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01686347     History of Changes
Other Study ID Numbers: 2010/146/HP
Study First Received: June 7, 2012
Last Updated: September 17, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013