Comparing Propofol and Spinal Analgesia for Fetal Positioning in Pregnancy
Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
This study is testing whether using propofol or spinal anesthesia is better for helping to safely turn a baby into the right position during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia Academic / other |
| Locations | 1 site (Murcia, Murcia) |
| Trial ID | NCT06449430 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of sedation with propofol versus spinal analgesia using bupivacaine during an External Cephalic Version (ECV) procedure, which is performed to reposition a fetus in a non-cephalic presentation. The study will evaluate the success rates of ECV, the incidence of complications, and the length of hospital stay associated with each sedation method. By assessing these factors, the trial seeks to determine if propofol can provide a safer and more efficient alternative to traditional spinal analgesia in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old with a non-cephalic presentation who wish to attempt a vaginal birth.
Not a fit: Patients who may not benefit from this study include those with multiple gestations, cephalic presentations, or contraindications for vaginal delivery.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for pregnant women undergoing ECV, potentially reducing the need for cesarean sections.
How similar studies have performed: While propofol is commonly used in various anesthetic procedures, its application in ECV has not been extensively studied, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * 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
Where this trial is running
Murcia, Murcia
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: Javier Sanchez Romero, MD
- Email: javier.sanchez14@um.es
- Phone: 968 36 95 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.