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Compares treatment options for Pregnancy Complications
Official title Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
ClinicalTrials.gov ID: NCT06449430
What this study is testing
What is Sedation with propofol?
Sedation with propofol is an investigational medicine, being studied as a potential treatment for pregnancy complications.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Voluntary participation.
- Older than 18 years.
- Non-cephalic presentation.
- Desire to attempt a vaginal birth.
- Normal blood count and coagulation prior to the intervention
You likely can't join if
- Age under 18 years old.
- Multiple gestation.
- Cephalic presentation.
- Risk of fetal compromise.
- Unexplained active bleeding.
- Absolute contraindication for vaginal delivery (Placenta Previa)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Murcia, Murcia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Murcia, Murcia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.