Back to resultsEpidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil (epidarc)
Primary Purpose
Fetal Cardiac Rhythm Abnormalities
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ropivacaine
Sponsored by
About this trial
This is an interventional basic science trial for Fetal Cardiac Rhythm Abnormalities focused on measuring epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil
Eligibility 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
Sites / Locations
- centre hospitalier universitaire de Rouen, Hopital Charles Nicolle
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
fetal cardiac rhythm abnormally
control group
Arm Description
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
Outcomes
Primary Outcome Measures
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
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
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
Full Information
NCT ID
NCT01686347
First Posted
June 7, 2012
Last Updated
January 22, 2016
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01686347
Brief Title
Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Acronym
epidarc
Official Title
Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Cardiac Rhythm Abnormalities
Keywords
epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fetal cardiac rhythm abnormally
Arm Type
Other
Arm Description
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
Arm Title
control group
Arm Type
Other
Arm Description
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Primary Outcome Measure Information:
Title
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
Description
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
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
centre hospitalier universitaire de Rouen, Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
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Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
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