Fetal Cardiac Rhythm AbnormalitiesPhase 4epidarcNCT01686347
Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
A Phase 4 study testing ropivacaine in people with Fetal Cardiac Rhythm Abnormalities, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Cardiac Rhythm Abnormalities
- What is being tested?
- ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or more
- nulliparous
- one fetus
- head first
- spontaneous labor
- epidural analgesia
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
centre hospitalier universitaire de Rouen, Hopital Charles Nicolle
Rouen, 76000
About this study
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
- Being tested
- ropivacaine
- Keywords
- epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Data analysis issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Cardiac Rhythm AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686347
- Sponsor's protocol ID
- 2010/146/HP
- Acronym
- epidarc
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2012
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
- ClinicalTrials.gov ID
- NCT01686347
- Acronym / sponsor ID
- epidarc / 2010/146/HP
- Conditions
- Fetal Cardiac Rhythm Abnormalities
- Keywords
- epidural analgesia, fetal cardiac rythm, ropivacaine, sufentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data analysis issue
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fetal cardiac rhythm abnormally | Other | Drug: ropivacainepatient at term, in spontanous labor with fetal cardiac rythm abnormally which occurs 30 minutes after the epidural analgesia induction |
| control group | Other | Drug: ropivacainepatient at term, spontaneous labor, without any fetal cardiac rhythm abnormalies during the 30 minutes after the epidural analgesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years old or more
- nulliparous
- one fetus
- head first
- spontaneous labor
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine | Drug | control group, fetal cardiac rhythm abnormally |
Primary outcome
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
Time frame: 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
1 secondary outcome
Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Data analysis issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine in people with Fetal Cardiac Rhythm Abnormalities, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data analysis issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.