Use of Propofol as a Sedative Agent Versus Spinal Analgesia With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pregnancy Complications

Clinical Trial Details

NCT number	NCT06449430
Study type	Interventional
Source	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Contact	Javier Sanchez Romero, MD
Phone	968 36 95 00
Email	javier.sanchez14@um.es
Status	Recruiting
Phase	N/A
Start date	May 28, 2024
Completion date	September 30, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms