Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV)
Phase 1
Recruiting
- Conditions
- External Cephalic VersionMedDRA version: 21.1Level: PTClassification code: 10070636Term: External cephalic version Class: 100000004865Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-510701-29-00
- Lead Sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 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., 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, 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method