Randomized clinical trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV): study protocol for a randomized clinical trial

Abstract

BACKGROUND: External Cephalic Version (ECV) is an effective procedure for modifying fetal position to achieve a cephalic presentation. ECV is usually performed with tocolysis and spinal anesthesia. Recently, propofol has been proposed as a sedative agent for ECV, showing promising results in observational studies. This clinical trial aims to compare the outcomes of ECV performed under tocolysis with either propofol or spinal anesthesia. METHODS: The PropoSpinECV randomized clinical trial is designed as a single-center, randomized, open-label trial. Participation will be offered to every pregnant woman with a non-cephalic presentation undergoing external cephalic version. Sedation with propofol and spinal analgesia with bupivacaine and fentanyl will be compared for ECV with a 1:1 allocation ratio. All procedures will be performed under tocolysis with ritodrine. The breech progression angle before ECV will be measured for all participants. The main outcome will be the ECV success rate. ECV complication rates and post-procedure pain will also be evaluated. DISCUSSION: The PropoSpinECV trial will thoroughly evaluate the efficacy of propofol in ECV. Additionally, this trial will investigate the role of the breech progression angle prior to ECV as a predictive variable for the success of the procedure. TRIAL REGISTRATION: The PropoSpinECV clinical trial is registered in the European Union Clinical Trial Database (EU CT number: 2024-510701-29-00) and in the ClinicalTrials.gov Database (NCT06449430) with the Clinical Trial Registry (2024-06-03).