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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

Page last updated: August 23, 2015

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