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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breech Presentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sedation

Midazolam : 0,10 mg/kg

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

spinal anesthesia

Bupivacain 10 mg

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Interventions

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Midazolam

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No