Labor PainPhase 4ICANCT03018171
Intrathecal Clonidine Addiction for Combined Spinal Epidural Analgesia During Labor
A Phase 4 study testing Clonidine and Sufentanil in people with Labor Pain, run by San Giovanni Calibita Fatebenefratelli Hospital at 1 site in Italy.
Trial summary
The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Clonidine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to Aug 2017
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Written maternal informed consent
- Singleton pregnancy
- Gestational age ≥ 37 weeks,
- ASA I
- BMI < 30
- fetus in cephalic presentation
Who cannot join
- Suspect or certainty of fetal malformation,
- Presence of conditions such as preeclampsia, multiparity, preterm labor
- History of adverse reaction to α-2 adrenergic agonists
- Nicotine addiction
- Chronic use of opioid
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Giovanni Calibita Fatebenefratelli, Tiberine Island, Hospital
Rome, 00186
Marco Aversano, MD, +39066837258, m.aversano@me.com
Claudia Claroni, MD
About this study
Official title: Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.
The study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.
- Conditions
- Labor Pain
- Being tested
- Clonidine, Sufentanil
- Keywords
- clonidine, spinal injections
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Intrathecal clonidine addiction
SufentanilDrug
Intrathecal
| Study group | Role | What they receive |
|---|---|---|
| SC | Experimental | this arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor Receives: Drug: Clonidine |
| S | Active comparator | this arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
local anesthetic consumption reduction
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Giovanni Calibita Fatebenefratelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Claroni, MD, Principal investigator, Fatebenefratelli San Giovanni Calibita - Tiberine Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018171
- Sponsor's protocol ID
- 01.17
- Acronym
- ICA
- Status last verified
- Apr 2017
- First submitted
- 10 Jan 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Maternal and Fetal Wellbeing and on Labor Curve of Intrathecal Clonidine Addiction for Labor Analgesia. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03018171
- Acronym / sponsor ID
- ICA / 01.17
- Conditions
- Labor Pain
- Keywords
- clonidine, spinal injections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- San Giovanni Calibita Fatebenefratelli HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 11 Jan 2017 (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 study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SC | Experimental | Drug: Clonidinethis arm will receive intrathecal clonidine addiction to sufentanil during combined spinal epidural analgesia for labor |
| S | Active comparator | Drug: Sufentanilthis arm will receive intrathecal sufentanil during combined spinal epidural analgesia for labor |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written maternal informed consent
- Singleton pregnancy
- Gestational age ≥ 37 weeks,
- ASA I
- BMI < 30
Key exclusion criteria (5 listed)
- Suspect or certainty of fetal malformation,
- Presence of conditions such as preeclampsia, multiparity, preterm labor
- History of adverse reaction to α-2 adrenergic agonists
- Nicotine addiction
- Chronic use of opioid
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 |
|---|---|---|
| ClonidineIntrathecal clonidine addiction | Drug | SC |
| SufentanilIntrathecal | Drug | S |
Primary outcome
local anesthetic consumption reduction
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
Claudia Claroni, MD principal investigator
Fatebenefratelli San Giovanni Calibita - Tiberine Island
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 Clonidine and Sufentanil in people with Labor Pain, run by San Giovanni Calibita Fatebenefratelli Hospital at 1 site in Italy.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Grazia Frigo, MD (+39066837258, mariagrazia.frigo@fbf-isola.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local anesthetic consumption reduction (time frame: 8 months). 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 27 Apr 2017.