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Randomized Clinical Trial of the use of Propofol as a sedative agent versus spinal analgesia with bupivacaine in External Cephalic Version (PropoSpinECV)
EU CTIS ID: 2024-510701-29-00
What this study is testing
The main objective of the project is to compare the success rate of ECV when used Propofol as a sedative agent or spinal analgesia.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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.
- 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
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.
- 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.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.