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

IMIB-ECV-2024-01

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.

2024-05-28

2025-05-31

2025-09-30

Recruiting

270

Inclusion Criteria: * Voluntary participation. * Older than 18 years. * Non-cephalic presentation. * Desire to attempt a vaginal birth. * Normal blood count and coagulation prior to the intervention Exclusion Criteria: * Age under 18 years old. * Multiple gestation. * Cephalic presentation. * Risk of fetal compromise. * Unexplained active bleeding. * Absolute contraindication for vaginal delivery (Placenta Previa) * 2 or more previous cesarean sections. * Previous myomectomy with entry into the uterine cavity * Maternal fever. * Thrombocytopenia (\<85,000 platelets). * Maternal spinal anomaly. * Intolerance or allergy to Propofol or any of its components. * Intolerance or allergy to bupivacaine or any of its components. * Contraindication for intrathecal sedation or analgesia

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 270, 'type': 'ESTIMATED'}}

2024-06-10