About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation.
Older than 18 years.
Non-cephalic presentation.
Desire to attempt a vaginal birth.
Disqualifiers
Age under 18 years old.
Multiple gestation.
Cephalic presentation.
Risk of fetal compromise.
Trial design
Parallel
Treatments tested in this trial
Sedation with propofol
DrugSedation with propofol
Spinal analgesia with bupivacaine
DrugSpinal analgesia with bupivacaine
Treatment groups
Trial outcomes
Primary outcomes
compare the success rate of external cephalic version
Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.
Secondary outcomes
ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.
Number of complications
rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV.
Number of emergency cesarean
postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV
Visual Analogue Scale (VAS) pain consists of 9 items on which participants rate their perceived dizziness on a scale between 1 (no dizziness) and 10 (most dizziness) in different visual vertigo-inducing environments
rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV
number of episodes of hypotension hypotension
Sponsors and contacts
Click on the lead sponsor to view all of their trials.