Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation
RaVem
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2016
CompletedStudy Start
First participant enrolled
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedAugust 8, 2018
August 1, 2018
3.4 years
May 27, 2016
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
24 hours
Secondary Outcomes (5)
occurrence of side events due to the manipulation itself
Day 0
occurrence of side events due to anesthesia
Day 0
The pain experienced by the patient: assessed by the Visual Analogic Scale
Day 0
The final delivery mode (caesarian section or vaginal)
Day 0
The presentation in childbirth
Day 0
Study Arms (2)
sedation
ACTIVE COMPARATORMidazolam : 0,10 mg/kg
spinal anesthesia
ACTIVE COMPARATORBupivacain 10 mg
Interventions
Eligibility Criteria
You may qualify if:
- age ≥ 18 years
- patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
- covered by a an insurance system
- signed contentment
You may not qualify if:
- Obstetric contraindications:
- placenta previa
- rd 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien CHEVREAU, MD
CHU Amiens
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2016
First Posted
June 15, 2016
Study Start
May 31, 2016
Primary Completion
October 30, 2019
Study Completion
November 30, 2019
Last Updated
August 8, 2018
Record last verified: 2018-08