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Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation (RaVem)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02801201
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : August 8, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breech Presentation Drug: Midazolam Drug: Bupivacaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
Actual Study Start Date : May 31, 2016
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: sedation
Midazolam : 0,10 mg/kg
Drug: Midazolam
Active Comparator: spinal anesthesia
Bupivacain 10 mg
Drug: Bupivacaine

Primary Outcome Measures :
  1. Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. occurrence of side events due to the manipulation itself [ Time Frame: Day 0 ]
    cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes

  2. occurrence of side events due to anesthesia [ Time Frame: Day 0 ]
    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).

  3. The pain experienced by the patient: assessed by the Visual Analogic Scale [ Time Frame: Day 0 ]
  4. The final delivery mode (caesarian section or vaginal) [ Time Frame: Day 0 ]
  5. The presentation in childbirth [ Time Frame: Day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age ≥ 18 years
  • patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
  • covered by a an insurance system
  • signed contentment

Exclusion Criteria:

Obstetric contraindications:

  • placenta previa
  • 3rd trimester bleeding
  • suspicion of fetal anoxia
  • patient has already received more than one caesarean section
  • multi-fetal pregnancy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02801201

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Contact: Julien CHEVREAU, MD +33 3 22 08 74 52

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CHU Amiens Recruiting
Amiens, France, 80054
Contact: Julien CHEVREAU, MD    03 22 08 74 52   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Principal Investigator: Julien CHEVREAU, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT02801201    
Other Study ID Numbers: PI2016_843_0001
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
spinal anesthesia
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action