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Study on the Effectiveness of Spinal Anesthesia vs. Sedation for Turning Breech Babies: Comparing Midazolam and Bupivacaine in Pregnant Women

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What is this trial about?

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

This clinical trial is focused on the effectiveness of different types of anaesthesia during a procedure called external version, which is used to change the position of a baby in the womb from a breech or sideways position to a head-down position. The study compares two methods: spinal anaesthesia and sedation. The main goal is to determine if spinal anaesthesia leads to a higher success rate in repositioning the baby compared to sedation.

The study involves the use of two medications: Midazolam, also known by its code name USL-261, which is used for sedation, and Bupivacaine, which is used for spinal anaesthesia. Midazolam is administered as a solution for injection or infusion, while Bupivacaine is given as an injectable solution. Participants in the study will receive either spinal anaesthesia or sedation during the procedure, and the outcomes will be compared to see which method is more effective.

Throughout the study, participants will be monitored for the success of the procedure, which is defined as the baby being in a head-down position after the procedure. Additionally, any side effects related to the procedure or the anaesthesia, such as changes in blood pressure or heart rate, will be recorded. The study aims to provide valuable information on the best anaesthesia method to use for this procedure, potentially improving outcomes for both mothers and babies.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), gestational age (36 weeks), and informed consent.

    The study focuses on patients with a fetus in a non-head-down position (dystocic presentation).

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: spinal anesthesia or sedation.

    This step determines the type of pain management used during the procedure.

  3. Step 3

    Preparation for procedure

    Participants receive either midazolam (1 mg/ml solution for injection or infusion) for sedation or bupivacaine hydrochloride (20 mg/4 ml solution for injection) for spinal anesthesia.

    The medication is administered as a solution for injection.

  4. Step 4

    External version procedure

    The procedure aims to turn the fetus to a head-down position (cephalic presentation).

    The success of the procedure is assessed immediately after completion.

  5. Step 5

    Post-procedure monitoring

    Participants are monitored for any secondary events related to the procedure or anesthesia, such as changes in heart rate, blood pressure, or oxygen levels.

    Pain levels are assessed using a visual scale.

  6. Step 6

    Follow-up

    The final outcome of the delivery is recorded, including the presentation at delivery and the route of delivery.

    The study aims to determine if spinal anesthesia results in a higher success rate compared to sedation.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Must be a **female patient**.
  • Must be **36 weeks pregnant** with a baby in a **difficult position** (either feet or side first).
  • Must have **social insurance** coverage.
  • Must have **signed a consent form** agreeing to participate in the study.

Who cannot join the trial?

3 criteria

  • Only female participants are allowed, so males cannot participate.
  • Participants must be within a specific age range, so those outside this range cannot join.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes people who might have a harder time making decisions for themselves or are at higher risk of harm.
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Investigated drugs

  • Spinal Anesthesia

    is a type of anesthesia used in this trial to help with the success of an external version procedure. It involves injecting medication near the spinal cord to numb the lower part of the body. This helps in reducing pain and discomfort during the procedure, which aims to change the baby's position in the womb from breech or transverse to head-down.

  • Sedation

    is another method used in the trial to help with the external version procedure. It involves giving medication to help the patient relax and feel sleepy, but not completely unconscious. This can make the procedure more comfortable and may help in changing the baby's position in the womb.

What is already known about the treatment

  • Spinal Anesthesia

    This medication is administered through an injection into the spinal fluid in the lower back, providing numbness and pain relief in the lower part of the body. It is currently used in medical practice for various surgical procedures and is well-documented in medical literature. The main therapeutic indication in this trial is to facilitate the success of external cephalic version, a procedure to turn a breech baby to a head-down position before birth. At the molecular level, spinal anesthesia works by blocking nerve signals in the spinal cord, preventing pain sensation. It is classified as a local anesthetic.

  • Sedation

    This medication is typically administered orally or intravenously to calm or relax a patient, often used in minor surgical or diagnostic procedures. In the context of this clinical trial, sedation is being compared to spinal anesthesia to determine its effectiveness in aiding the success of external cephalic version. Sedation works by depressing the central nervous system, leading to relaxation and reduced awareness. It is classified as a sedative or anxiolytic.

Investigated diseases

  • Bradycardia

    Bradycardia is a condition characterized by a slower than normal heart rate, typically defined as fewer than 60 beats per minute in adults. It can occur naturally in some individuals, such as athletes, or be a result of aging or heart-related conditions. Symptoms may include fatigue, dizziness, or fainting, but some people may not experience any symptoms. The condition can be temporary or chronic, depending on the underlying cause. Bradycardia can affect the heart's ability to pump enough blood to meet the body's needs, especially during physical activity. It is important to monitor the heart rate and seek medical advice if symptoms are present.

  • Hypotension

    Hypotension, or low blood pressure, occurs when the blood pressure in the arteries is lower than normal. It can cause symptoms such as dizziness, fainting, blurred vision, or nausea, especially when standing up quickly. While it may be harmless in some individuals, it can indicate an underlying health issue in others. Causes can include dehydration, heart problems, or endocrine disorders. Hypotension can affect the body's ability to deliver adequate blood flow to organs and tissues. Monitoring and understanding the cause of low blood pressure is important for managing symptoms and maintaining health.

  • Rupture of Membranes

    Rupture of membranes refers to the breaking of the amniotic sac, which surrounds and protects the fetus during pregnancy. This event is commonly known as "water breaking" and usually signals the onset of labor. It can occur spontaneously at full term or prematurely, which may require medical attention. The rupture can lead to a release of amniotic fluid, and it is important to monitor for signs of infection or complications. In some cases, medical intervention may be necessary to ensure the safety of both the mother and the baby. Understanding the timing and nature of the rupture is crucial for appropriate management during childbirth.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517302-29-00Estimated enrolment200 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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