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

Centre Hospitalier Universitaire, Amiens

Status and phase: Unknown; Phase 3

Conditions: Breech Presentation

Treatments: Drug: Midazolam; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02801201

PI2016_843_0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

sedation

Active Comparator group

Description:

Midazolam : 0,10 mg/kg

Treatment:

Drug: Midazolam

spinal anesthesia

Active Comparator group

Description:

Bupivacain 10 mg

Treatment:

Drug: Bupivacaine