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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01686347
Acronym
epidarc
Enrollment
40
Registered
2012-09-18
Start date
2012-06-01
Completion date
2015-12-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Cardiac Rhythm Abnormalities

Keywords

epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil

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.

Interventions

DRUGropivacaine

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate1 dayMaternal 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

MeasureTime frameDescription
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate1 dayMaternal 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026