Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449430
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-28
Brief Title:
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
Organization:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Overview
Official Title:
Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PropoSpinECV
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None