Breech PresentationPhase 3NCT01048398
Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.
A Phase 3 study testing remifentanil and paracetamol in people with Breech Presentation and Pregnancy, run by Basque Health Service at 1 site in Spain.
Trial summary
BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination. 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
- Breech Presentation, Pregnancy
- What is being tested?
- remifentanil and paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Apr 2011
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
- Informed consent signed by the mother or legal representative in his absence.
Who cannot join
- Fetal anomalies
- Severe hypertension
- Allergy to drug used in the test
- Amniotic fluid index ≥ 5 cm
- Contraindication for vaginal delivery
- Uterine abnormality and impaired coagulation
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- Placenta previa
- Rh sensitization
- Multiple gestation
- Ruptured membranes
- Premature detachment of normally inserted placenta
- The mother greater weight to 85kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.
OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.
Read more
PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.
Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.
Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events
- Conditions
- Breech Presentation, Pregnancy
- Being tested
- remifentanil, paracetamol
- Keywords
- ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
paracetamolDrug
Also called acetoaminophen
Control group: intravenous paracetamol 1g
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | Not described Receives: Drug: remifentanil |
| Paracetamol | Active comparator | intravenous paracetamol 1g Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of decrease in pain experienced by patients during the maneuver according to the VAS
Measured: 10 minutes
Secondary outcomes (2)
Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
Measured: 1 day
Number of adverse events and severity
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 posted13 Jan 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Investigators
- Cesar A Valero, MD, Principal investigator, Basque Health ServiceHenar Muñoz, MD, Study chair, Basque Health ServiceAmanda Lopez, Study chair, Basque Health ServiceSandra Guerra, MD, Study chair, Basque Health ServiceOlga Echebarria, MD, Study chair, Basque Health ServiceAlfonso Velasco, MD, Study chair, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048398
- Sponsor's protocol ID
- REMI-001
- Status last verified
- Sep 2010
- First submitted
- 12 Jan 2010
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
- ClinicalTrials.gov ID
- NCT01048398
- Acronym / sponsor ID
- REMI-001
- Conditions
- Breech Presentation, Pregnancy
- Keywords
- ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 Jan 2010 (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.
BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.
OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.
PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.
Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.
Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: remifentanil |
| Paracetamol | Active comparator | Drug: paracetamolintravenous paracetamol 1g |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
- Informed consent signed by the mother or legal representative in his absence.
Key exclusion criteria (12 listed)
- Fetal anomalies
- Severe hypertension
- Allergy to drug used in the test
- Amniotic fluid index ≥ 5 cm
- Contraindication for vaginal delivery
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 |
|---|---|---|
| remifentanilintervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline. | Drug | Remifentanil |
| paracetamolAlso: acetoaminophenControl group: intravenous paracetamol 1g | Drug | Paracetamol |
Primary outcome
Degree of decrease in pain experienced by patients during the maneuver according to the VAS
Time frame: 10 minutes
2 secondary outcomes
Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
Time frame: 1 day
Number of adverse events and severity
Time frame: 1 day
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 14 Apr 2011.
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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.
Cesar A Valero, MD principal investigator
Basque Health Service
Henar Muñoz, MD study chair
Basque Health Service
Amanda Lopez study chair
Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing remifentanil and paracetamol in people with Breech Presentation and Pregnancy, run by Basque Health Service at 1 site in Spain.
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 2 inclusion and 12 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 14 Apr 2011. 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 Spain. 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?
Degree of decrease in pain experienced by patients during the maneuver according to the VAS (time frame: 10 minutes). 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 14 Apr 2011.