Normal PregnancyPhase 3NCT00437996
Comparative Affect of a Continuous Epidural Infusion of Clonidine During Labour. Prospective Double Blind Randomized Trial
A Phase 3 study testing Clonidine, Levobupivacaine and Sufentanil in people with Normal Pregnancy, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Pregnancy
- What is being tested?
- Clonidine, Levobupivacaine and Sufentanil
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2007to Jan 2008
- Phase
- Phase 3
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of ASA class I or II
- Variable parity
- Aged of 18 years or more
- With a normal pregnancy
- Cervical dilation between 3 and 8 cm)
- Wishing an epidural analgesia
Show all 10Show fewer
- Normal childbirth
- Giving their written assent
- Affiliated with a social security system
- Must have had an anaesthesia consultation more than 48 hours before inclusion.
Who cannot join
- Request of the patient
- Failure of epidural analgesia
- Childbirth in the 90 minutes following the induction of analgesia
- Realization of a Caesarean section
Trial locations and contacts
2 sites in 1 country.
France2 sites
Henri Jacques CLEMENT
Lyon, 69000
Anesthesie Reanimation - Gynecologie - Hopital de La Croix Rousse
Lyon, 69004
About this study
Official title: Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.
- Conditions
- Normal Pregnancy
- Being tested
- Clonidine, Levobupivacaine, Sufentanil
- Keywords
- Labor analgesia - clonidine - epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
LevobupivacaineDrug
SufentanilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
Secondary outcomes (3)
Motor blockade quantification by a score of modified Bromage specific way.
Labor analgesia.
Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- HENRI-JACQUES CLEMENT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437996
- Sponsor's protocol ID
- 2006.424
- Status last verified
- Jun 2009
- First submitted
- 19 Feb 2007
- Last updated
- 30 Jun 2009
- Results posted
- No
Publications
Wallet F, Clement HJ, Bouret C, Lopez F, Broisin F, Pignal C, Schoeffler M, Derre E, Charpiat B, Huissoud C, Aubrun F, Viale JP. Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 May;27(5):441-7. doi: 10.1097/EJA.0b013e3283365944.
PubMed 20299988
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
- ClinicalTrials.gov ID
- NCT00437996
- Acronym / sponsor ID
- 2006.424
- Conditions
- Normal Pregnancy
- Keywords
- Labor analgesia - clonidine - epidural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 21 Feb 2007 (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.
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients of ASA class I or II
- Variable parity
- Aged of 18 years or more
- With a normal pregnancy
- Cervical dilation between 3 and 8 cm)
Key exclusion criteria (4 listed)
- Request of the patient
- Failure of epidural analgesia
- Childbirth in the 90 minutes following the induction of analgesia
- Realization of a Caesarean section
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 |
|---|---|---|
| Clonidine | Drug | – |
| Levobupivacaine | Drug | – |
| Sufentanil | Drug | – |
Primary outcome
Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
3 secondary outcomes
Motor blockade quantification by a score of modified Bromage specific way.
Labor analgesia.
Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Derived from this study: PubMed 20299988Wallet F, Clement HJ, Bouret C, Lopez F, Broisin F, Pignal C, Schoeffler M, Derre E, Charpiat B, Huissoud C, Aubrun F, Viale JP. Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2010 May;27(5):441-7. doi: 10.1097/EJA.0b013e3283365944.
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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.
HENRI-JACQUES CLEMENT, MD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clonidine, Levobupivacaine and Sufentanil in people with Normal Pregnancy, run by Hospices Civils de Lyon at 2 sites 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 4 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: finished, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00437996, which also lists 1 linked publication.
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 30 Jun 2009.