Clinical Trial

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

Study acronym: PropoSpinECV
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-03.
Trial Details
NCT Number NCT06449430
Lead Sponsor Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions Pregnancy Complications
Enrollment 270 participants
Start Date 2024-07-06
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-21