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

Phase 4

Completed

• Conditions: Fetal Cardiac Rhythm Abnormalities
• Interventions: Drug: ropivacaine

• Registration Number: NCT01686347
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fetal cardiac rhythm abnormally	ropivacaine	patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction
control group	ropivacaine	patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction

Primary Outcome Measures

Name	Time	Method
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate	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 Outcome Measures

Name	Time	Method
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate	1 day	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

Trial Locations

Locations (1)

centre hospitalier universitaire de Rouen, Hopital Charles Nicolle; 🇫🇷 Rouen, France