Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fetal Cardiac Rhythm Abnormalities
Intervention: ropivacaine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Rouen Overall contact: PIZZAGALLI franck, midwife, Phone: +33232888990, Ext: 64286, Email: franck.pizzagali@chu-rouen.fr
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.
Clinical Details
Official title: Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
Secondary outcome: Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
PIZZAGALLI franck, midwife, Phone: +33232888990, Ext: 64286, Email: franck.pizzagali@chu-rouen.fr
centre hospitalier universitaire de Rouen, Hopital Charles Nicolle, Rouen 76000, France; Recruiting pizzagalli franck, widwife, Phone: 0232888990, Ext: 64286, Email: franck.pizzagali@chu-rouen.fr
Additional Information
Starting date: June 2012
Last updated: July 29, 2015
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