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

Study Overview
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Brief Summary
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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.

Official Title
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Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil

Conditions
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Fetal Cardiac Rhythm Abnormalities

Intervention / Treatment
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* Drug: ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil