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

NCT ID: NCT01686347

Last Updated: 2016-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Fetal Cardiac Rhythm Abnormalities

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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fetal cardiac rhythm abnormally

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

Group Type OTHER

ropivacaine

Intervention Type DRUG

control group

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

Group Type OTHER

ropivacaine

Intervention Type DRUG

Interventions

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ropivacaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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centre hospitalier universitaire de Rouen, Hopital Charles Nicolle

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2010/146/HP

Identifier Type: -

Identifier Source: org_study_id

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