Ongoing Clinical Trials for External Cephalic Version
Currently, there is 1 ongoing clinical trial investigating pain management methods during External Cephalic Version procedures. This trial is comparing two different approaches to make the procedure more comfortable for pregnant women: sedation with Propofol versus spinal pain relief with Bupivacaine. The study is being conducted in Spain and aims to determine which method results in more successful baby turning procedures while ensuring patient comfort and safety.
Clinical trial locations
Comparison of Propofol sedation versus Bupivacaine spinal analgesia in patients undergoing External Cephalic Version procedure
This clinical trial is examining two different pain management approaches for women undergoing External Cephalic Version, a procedure used to turn a baby from a breech position (buttocks or feet first) to the normal head-down position before birth. The study is taking place in Spain and will run until July 2026.
Main inclusion criteria:
- Women over 18 years of age who are pregnant and at least 36 weeks along
- Baby must be in a non-cephalic presentation (not positioned head-down)
- Desire to attempt vaginal delivery rather than a planned cesarean section
- Normal blood test results, including normal blood count and clotting tests
- Voluntary agreement to participate in the study
Main exclusion criteria:
- Previous uterine surgery, including prior cesarean section
- Multiple pregnancy (carrying twins or more)
- Any vaginal bleeding during the current pregnancy
- Problems with the placenta or known fetal abnormalities
- Broken water or active labor
- Known allergies to the medications being studied
- Blood clotting disorders or severe pregnancy complications like preeclampsia
- Obesity with BMI over 40
- Less than 36 weeks pregnant
Focus and goals:
The primary goal of this study is to determine which pain management method results in more successful External Cephalic Version procedures. Participants will be randomly assigned to one of two groups. The first group will receive Propofol, a fast-acting sedative that causes sleepiness and relaxation during the procedure. The second group will receive Bupivacaine, a numbing medication administered through spinal injection that blocks pain signals in the lower part of the body.
During the procedure, the medical team will carefully monitor various aspects of patient comfort and safety, including pain levels, blood pressure changes, and any side effects such as dizziness or nausea. The study will also track how effectively each method helps turn the baby into the correct head-down position.
After the procedure, participants will be monitored for 24 hours to assess immediate outcomes and any complications. Follow-up will continue until the end of the study period to evaluate the overall success rate and any need for urgent cesarean section.
Investigational drugs:
Propofol is a fast-acting sedative medication that helps patients relax during medical procedures by enhancing certain neurotransmitters in the brain. It produces a state of controlled sedation and is valued for its quick onset and short recovery time, making it suitable for procedures like External Cephalic Version.
Bupivacaine is a long-acting local anesthetic administered through spinal injection. It works by blocking sodium channels in nerve cells, preventing pain signals from being transmitted and creating temporary numbness in the targeted area. This allows patients to remain conscious during the procedure while experiencing effective pain relief.
Summary
Currently, only one clinical trial is actively investigating External Cephalic Version procedures. This Spanish study represents an important effort to improve the experience and success rate of this procedure by comparing two fundamentally different approaches to pain management: sedation versus regional anesthesia. The trial focuses on determining not only which method is more effective at facilitating successful baby turning, but also which approach provides better patient comfort and safety outcomes. Given that breech presentation occurs in approximately 3-4% of pregnancies at term, research like this could potentially benefit many pregnant women seeking to avoid cesarean delivery. The study’s comprehensive monitoring approach, including assessment of pain levels, blood pressure changes, and various side effects, will provide valuable data to guide future clinical practice in obstetric care.
