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RECRUITING
NCT06449430
NA

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

Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2024-07-06

Completion Date

2027-11-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Sedation with propofol

Sedation with propofol

DRUG

Spinal analgesia with bupivacaine

Spinal analgesia with bupivacaine

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain