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

Centre Hospitalier Universitaire, Amiens200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Breech Presentation

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

occurrence of side events due to the manipulation itself

cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes

Time frame: Day 0

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).

Time frame: Day 0

The pain experienced by the patient: assessed by the Visual Analogic Scale

Time frame: Day 0

The final delivery mode (caesarian section or vaginal)

Time frame: Day 0

The presentation in childbirth

Time frame: Day 0

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts