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

August 7, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: sedation
Midazolam : 0,10 mg/kg
Drug: Midazolam
ACTIVE_COMPARATOR: spinal anesthesia
Bupivacain 10 mg
Drug: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of side events due to the manipulation itself
Time Frame: Day 0
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
Day 0
occurrence of side events due to anesthesia
Time Frame: Day 0
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).
Day 0
The pain experienced by the patient: assessed by the Visual Analogic Scale
Time Frame: Day 0
Day 0
The final delivery mode (caesarian section or vaginal)
Time Frame: Day 0
Day 0
The presentation in childbirth
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Julien CHEVREAU, MD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2016

Primary Completion (ANTICIPATED)

October 30, 2019

Study Completion (ANTICIPATED)

November 30, 2019

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (ESTIMATE)

June 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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