Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV)

Authors
Category Primary study
Registry of TrialsClinical Trials Information System
Year 2024
INTERVENTION: Product Name: Bupivacaína B. Braun 5 mg/ml solución inyectable,Product Code: PRD568914,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Bupivacaine Hydrochloride 5mg,Product Name: Fentanest 0,05 mg/ml solución inyectable,Product Code: PRD406442,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Fentanyl Citrate 0.079mg,Product Name: Propofol Fresenius 10 mg/ml emulsión para inyección o perfusión,Product Code: PRD409198,Pharmaceutical Form: EMULSION FOR INJECTION/INFUSION,Other descriptive name: ,Strength: Propofol 10mg CONDITION: External Cephalic Version ; MedDRA version: 21.1Level: PTClassification code: 10070636Term: External cephalic versionSystem Organ Class: 100000004865 MedDRA version: 21.1Level: PTClassification code: 10070636Term: External cephalic versionSystem Organ Class: 100000004865 Therapeutic area: Diseases [C] ‐ Female Urogenital Diseases and Pregnancy Complications [C13] PRIMARY OUTCOME: Main Objective:The main objective of the project is to compare the success rate of ECV when used Propofol as a sedative agent or spinal analgesia. Primary end point(s):The primary end point is the ECV outcome. Secondary Objective:Compare the complication rate of ECV when using Propofol as an agent sedative or spinal analgesia.,Compare the rate of emergency cesarean sections in the first 24 hours after procedure when Propofol is used as a sedative agent or spinal analgesia in the ECV.,Compare post‐procedure pain when using Propofol as a sedative agent or spinal analgesia in the ECV.,Compare the rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as an agent sedative or spinal analgesia in the ECV.,Compare the rate of nausea or vomiting when using Propofol as an agent sedative or spinal analgesia in the ECV.,Analyze the angle of progression of fetal presentation as a predictor of success of the ECV,Analyze the angle of progression of fetal presentation as a predictor of complications of ECV.,Describe the degree of tissue oxygenation of the placenta during ECV using the analysis of a pilot sample with infrared spectroscopy (NIRS) SECONDARY OUTCOME: Secondary end point(s):Secondary outcome variables are complications of ECV, urgent cesarean section during the first 24 hours after the procedure, VAS scale, postoperative pain survey, clinically relevant hypotension, nausea, vomiting. 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
Epistemonikos ID: 051ea3bf8b4d9a6efeafb408b336d4033996f125
First added on: Aug 28, 2024