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Comparison of Propofol sedation versus Bupivacaine spinal analgesia in patients undergoing External Cephalic Version procedure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on External Cephalic Version (ECV), a medical procedure used to turn a baby from a breech position to a head-down position before birth. The research compares two different methods of pain management during this procedure: sedation with Propofol versus spinal pain relief with Bupivacaine.

The study aims to determine which method results in more successful baby turning procedures. During the procedure, patients will receive either Propofol, a medication that causes sleepiness and relaxation, or Bupivacaine, a numbing medication injected into the spine. Some patients may also receive Fentanyl, a strong pain medication, as part of their treatment.

The medications will be given through an injection in the spine, known as epidural use. The study will monitor various aspects of patient comfort and safety, including pain levels, dizziness, nausea, and changes in blood pressure. The medical team will also track how well each method works for successfully turning the baby into the correct position.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medical assessment

    A blood test will be performed to check your blood count and coagulation levels.

    Your pregnancy position will be confirmed as non-cephalic (baby not in head-down position).

  2. Step 2

    Random group assignment

    You will be randomly assigned to one of two groups:

    Group 1: Treatment with Propofol (sedative medication)

    Group 2: Treatment with spinal analgesia using bupivacaine (numbing medication)

  3. Step 3

    External Cephalic Version procedure

    The External Cephalic Version (ECV) procedure will be performed to try to turn the baby into a head-down position.

    During the procedure, you will receive either Propofol or spinal analgesia depending on your assigned group.

    The medical team will monitor you for any immediate complications.

  4. Step 4

    Post-procedure monitoring

    You will be monitored for 24 hours after the procedure.

    The medical team will assess for:

    - Pain levels using a simple rating scale

    - Blood pressure changes

    - Presence of nausea or vomiting

    - Any other complications

  5. Step 5

    Follow-up assessment

    Your progress will be monitored until the end of the study period (July 2026).

    The success of the baby's position change will be evaluated.

    Any additional complications or needs for urgent cesarean section will be documented.

Who can join the trial?

7 criteria

  • Must agree to participate voluntarily in the study
  • Must be over 18 years of age
  • Must have a non-cephalic presentation (baby is not positioned head-down in the uterus)
  • Must want to attempt a vaginal delivery (natural childbirth)
  • Must have normal blood test results, including:
    • Normal complete blood count (measures red blood cells, white blood cells, and platelets)
    • Normal blood clotting tests
    • Must be female

Who cannot join the trial?

15 criteria

  • Previous uterine surgery including cesarean section
  • Multiple pregnancy (carrying more than one baby)
  • Any form of vaginal bleeding during the current pregnancy
  • Placental abnormalities (problems with the position or condition of the placenta)
  • Known fetal abnormalities (problems with baby's development)
  • Rupture of membranes (broken water)
  • Active labor (having regular contractions)
  • Known allergies to medications used in the procedure
  • Coagulation disorders (blood clotting problems)
  • Severe pregnancy complications like preeclampsia
  • Significant medical conditions that could affect anesthesia safety
  • Less than 36 weeks of pregnancy
  • Obesity with BMI over 40
  • Unwillingness to receive either type of anesthesia (spinal or propofol)
  • Inability to provide informed consent
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Investigated drugs

  • Propofol

    is a fast-acting sedative medication used to help patients relax during medical procedures. In this trial, it is used as a sedative agent during External Cephalic Version (ECV), a procedure to turn a baby from breech position to head-down position before birth.

  • Bupivacaine

    is a local anesthetic medication used for spinal anesthesia. When injected into the spine, it blocks pain signals and provides numbness in the lower part of the body. In this trial, it is used to provide pain relief and relaxation during the External Cephalic Version procedure.

What is already known about the treatment

  • Propofol

    A fast-acting intravenous anesthetic medication used for sedation during medical procedures, particularly in this case for External Cephalic Version. This medication works by enhancing the effects of GABA neurotransmitters in the brain, producing a state of controlled sedation and unconsciousness. Propofol is widely used in modern medicine due to its quick onset and short recovery time, making it particularly suitable for short procedures requiring sedation.

  • Bupivacaine

    A long-acting local anesthetic medication administered through spinal injection to provide regional anesthesia and pain relief. This medication works by blocking sodium channels in nerve cells, preventing the transmission of nerve impulses and creating temporary numbness in the targeted area. Bupivacaine is commonly used in obstetric procedures and surgeries, providing effective pain control while allowing the patient to remain conscious during medical procedures.

Investigated diseases

  • Breech Presentation

    A condition where a baby is positioned with its buttocks or feet first in the uterus, rather than the normal head-first position. This positioning typically becomes apparent in the third trimester of pregnancy. The condition occurs in approximately 3-4% of pregnancies at term. The position can sometimes change naturally as the pregnancy progresses, though it may remain unchanged until delivery. Breech presentation can be influenced by factors such as uterine shape, multiple pregnancies, or amniotic fluid volume.

  • External Cephalic Version

    A procedure performed during pregnancy where the healthcare provider applies pressure to the mother's abdomen to turn the baby from a breech position to a head-down position. This procedure is typically performed around 37 weeks of pregnancy. The maneuver involves carefully manipulating the baby through the abdominal wall, using ultrasound guidance to monitor the baby's position. Success rates vary depending on various factors including the mother's body type, amount of amniotic fluid, and the baby's position.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510701-29-00Protocol codeIMIB-ECV-2024-01Estimated enrolment270 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

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