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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
University Clinical Hospital Virgen De La Arrixaca Murcia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
31.05.2024

Trial locations

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.

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 ID:
2024-510701-29-00
Protocol code:
IMIB-ECV-2024-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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