Suspended

epidarcAssociation Between Fetal Cardiac Rhythm Abnormalities and Maternal Systemic Transfer of Ropivacaine and Sufentanil

Study Aim

This study aims to compare the levels of ropivacaine in the blood of mothers whose fetuses have abnormal heart rates to those whose fetuses have normal heart rates.

What is being tested

ropivacaine

+ ropivacaine

Drug

Who is being recruted

Over 18 Years

See all eligibility criteria

How is the trial designed

Basic Science Study

Phase 4

Interventional

Study Start: June 2012

See protocol details

Summary

Principal SponsorUniversity Hospital, Rouen

Last updated: May 4, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on understanding the relationship between epidural analgesia used during labor and changes in the baby's heart rhythm. The pain relief medications under investigation are ropivacaine and sufentanil. The study aims to determine if these medications, when used by the mother, can pass into her bloodstream and potentially affect the baby's heart rhythm. This research is important as it could help improve the safety and effectiveness of pain management during childbirth, ensuring the best possible care for both mother and baby.

NCT01686347

Principal SponsorUniversity Hospital, Rouen

Last updated: May 4, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

centre hospitalier universitaire de Rouen, Hopital Charles Nicolle

Rouen, FranceOpen centre hospitalier universitaire de Rouen, Hopital Charles Nicolle in Google Maps

SuspendedOne Study Center