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New study tests propofol vs spinal analgesia for breech baby turn

NCT ID NCT06449430

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two pain relief methods—propofol sedation and spinal analgesia with bupivacaine—during a procedure to turn breech babies (external cephalic version). The goal is to see which method leads to more successful turns and fewer complications. 270 pregnant women with breech babies will be randomly assigned to one of the two groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
propofol and bupivacaine
What this could lead to
If it works, this could show that propofol sedation is a better option for turning breech babies, potentially reducing the need for C-sections.
What could go wrong
This is a moderate-sized trial with no phase designation, so results may not be definitive. Both sedation and spinal analgesia carry risks like allergic reactions or temporary side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * Age under 18 years old. * 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Murcia, 30120, Spain

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