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

NCT01686347 | Terminated Phase 4

• 1 other identifier: 2010/146/HP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Cardiac Rhythm Abnormalities

Keywords

epidural analgesia; fetal cardiac rythm; ropivacaine; sufentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate

  1 day

Study Arms (2)

fetal cardiac rhythm abnormally

OTHER

patient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction

Drug: ropivacaine

control group

OTHER

patient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction

Drug: ropivacaine

Interventions

ropivacaine DRUG

control group; fetal cardiac rhythm abnormally

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

centre hospitalier universitaire de Rouen, Hopital Charles Nicolle

Rouen, 76000, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: September 18, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

FR (1)