Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic… (NCT06449430) | Clinical Trial Compass
RecruitingNot Applicable
Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Spain270 participantsStarted 2024-07-06
Plain-language summary
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections.
Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
compare the success rate of external cephalic version
Timeframe: Up to 24 months.
Trial details
NCT IDNCT06449430
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia