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

Primary Purpose

Breech Presentation

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Midazolam
Bupivacaine
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breech Presentation focused on measuring sedation, spinal anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

sedation

spinal anesthesia

Arm Description

Midazolam : 0,10 mg/kg

Bupivacain 10 mg

Outcomes

Primary Outcome Measures

Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation

Secondary Outcome Measures

occurrence of side events due to the manipulation itself
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
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).
The pain experienced by the patient: assessed by the Visual Analogic Scale
The final delivery mode (caesarian section or vaginal)
The presentation in childbirth

Full Information

First Posted
May 27, 2016
Last Updated
August 7, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02801201
Brief Title
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation
Acronym
RaVem
Official Title
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breech Presentation
Keywords
sedation, spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sedation
Arm Type
Active Comparator
Arm Description
Midazolam : 0,10 mg/kg
Arm Title
spinal anesthesia
Arm Type
Active Comparator
Arm Description
Bupivacain 10 mg
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Primary Outcome Measure Information:
Title
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
occurrence of side events due to the manipulation itself
Description
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
Time Frame
Day 0
Title
occurrence of side events due to anesthesia
Description
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).
Time Frame
Day 0
Title
The pain experienced by the patient: assessed by the Visual Analogic Scale
Time Frame
Day 0
Title
The final delivery mode (caesarian section or vaginal)
Time Frame
Day 0
Title
The presentation in childbirth
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien CHEVREAU, MD
Phone
+33 3 22 08 74 52
Email
chevreau.julien@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien CHEVREAU, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien CHEVREAU, MD
Phone
03 22 08 74 52
Email
chevreau.julien@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

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

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