Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Overview
- Phase
- Phase 4
- Intervention
- ropivacaine
- Conditions
- Fetal Cardiac Rhythm Abnormalities
- Sponsor
- University Hospital, Rouen
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
- •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
Arms & Interventions
fetal cardiac rhythm abnormally
patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
Intervention: ropivacaine
control group
patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction
Intervention: ropivacaine
Outcomes
Primary Outcomes
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 Outcomes
- Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate(1 day)