NCT06449430

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are: * To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia. Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.

Conditions

• Pregnancy Complications

Interventions

Type	Name	Description
DRUG	Sedation with propofol	Sedation with propofol
DRUG	Spinal analgesia with bupivacaine	Spinal analgesia with bupivacaine

Timeline

• Start date: 2024-07-06
• Primary completion: 2027-10-31
• Completion: 2027-11-30
• First posted: 2024-06-10
• Last updated: 2025-11-21

Locations

1 site across 1 country: Spain