CTIS2024-510701-29-00
Recruiting
Phase 1
Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV) - IMIB-ECV-2024-01
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia0 sites270 target enrollmentMarch 1, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- External Cephalic Version
- Sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Enrollment
- 270
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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