Breech PresentationPhase 3RaVemNCT02801201
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation
A Phase 3 study testing Midazolam and Bupivacaine in people with Breech Presentation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breech Presentation
- What is being tested?
- Midazolam and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2016to 8 Dec 2025
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age ≥ 18 years
- patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
- covered by a an insurance system
- signed contentment
Who cannot join
- Obstetric contraindications:
- placenta previa
- 3rd trimester bleeding
- suspicion of fetal anoxia
- patient has already received more than one caesarean section
- multi-fetal pregnancy
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- HIV +
- anticoagulant therapy
- Anesthesiologic contraindications:
- infection at the puncture site, systemic infection or severe sepsis
- intracranial hypertension
- uncompensated heart failure
- constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent
- neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery
- syringomyelia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.
- Conditions
- Breech Presentation
- Being tested
- Midazolam, Bupivacaine
- Keywords
- sedation, spinal anesthesia
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| sedation | Active comparator | Midazolam : 0,10 mg/kg Receives: Drug: Midazolam |
| spinal anesthesia | Active comparator | Bupivacain 10 mg Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
Measured: 24 hours
Secondary outcomes (5)
occurrence of side events due to the manipulation itself
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
Measured: Day 0
occurrence of side events due to anesthesia
hypotension, maternal bradycardia, desaturation, nausea / vomiting, number of punctures greater than 1 (failure of the first puncture for spinal anesthesia leading to the necessity to perform one or more others).
Measured: Day 0
The pain experienced by the patient: assessed by the Visual Analogic Scale
Measured: Day 0
The final delivery mode (caesarian section or vaginal)
Measured: Day 0
The presentation in childbirth
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start31 May 2016
- Primary completion26 Dec 2024
- Study completion8 Dec 2025
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.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien CHEVREAU, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801201
- Sponsor's protocol ID
- PI2016_843_0001
- Acronym
- RaVem
- Status last verified
- Jun 2026
- First submitted
- 27 May 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT02801201
- Acronym / sponsor ID
- RaVem / PI2016_843_0001
- Conditions
- Breech Presentation
- Keywords
- sedation, spinal anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 15 Jun 2016 (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.
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedation | Active comparator | Drug: MidazolamMidazolam : 0,10 mg/kg |
| spinal anesthesia | Active comparator | Drug: BupivacaineBupivacain 10 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
- covered by a an insurance system
- signed contentment
Key exclusion criteria (15 listed)
- placenta previa
- 3rd trimester bleeding
- suspicion of fetal anoxia
- patient has already received more than one caesarean section
- multi-fetal pregnancy
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 |
|---|---|---|
| Midazolam | Drug | sedation |
| Bupivacaine | Drug | spinal anesthesia |
Primary outcome
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
Time frame: 24 hours
5 secondary outcomes
occurrence of side events due to the manipulation itself
Time frame: Day 0
occurrence of side events due to anesthesia
Time frame: Day 0
The pain experienced by the patient: assessed by the Visual Analogic Scale
Time frame: Day 0
The final delivery mode (caesarian section or vaginal)
Time frame: Day 0
The presentation in childbirth
Time frame: Day 0
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 11 Jun 2026.
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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.
Julien CHEVREAU, MD principal investigator
CHU Amiens
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 Midazolam and Bupivacaine in people with Breech Presentation, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 15 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 11 Jun 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 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?
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation (time frame: 24 hours). 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 11 Jun 2026.