Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06449430

Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-11-21

270

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections. Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.

CONDITIONS

Official Title

Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation
  • Age 18 years or older
  • Non-cephalic fetal presentation
  • Desire to attempt vaginal birth
  • Normal blood count and coagulation before the procedure
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Multiple pregnancies
  • Baby in head-down position
  • Risk of fetal compromise
  • Unexplained active bleeding
  • Absolute contraindication for vaginal delivery (Placenta Previa)
  • Two or more previous cesarean sections
  • Previous myomectomy with entry into the uterine cavity
  • Maternal fever
  • Low platelet count (less than 85,000 platelets)
  • Maternal spinal abnormalities
  • Allergy or intolerance to propofol or its components
  • Allergy or intolerance to bupivacaine or its components
  • Contraindication for intrathecal sedation or analgesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain, 30120

Actively Recruiting

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Research Team

J

Javier Sanchez Romero, MD

CONTACT

C

Catalina De Paco Matallana, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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