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New device aims to ease painful birth scars without drugs

NCT ID NCT05345600

Symptom relief Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called MILTA, which uses light and magnetic fields, to reduce pain from perineal scars after childbirth. About 110 women with moderate to severe pain will receive either MILTA or a placebo treatment in two sessions. The goal is to see if this non-drug approach can help manage acute and chronic scar pain.

What this could mean

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

Active substance
MILTA probe (light and magnetic therapy device)
What this could lead to
If it works, this could offer a non-drug option to ease pain from perineal scars after delivery.
What could go wrong
This is a small pilot study with only 110 participants, so results may not apply widely. The treatment is new for this use and may not reduce pain better than placebo.

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

110 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Nov 2025

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: * vaginal delivery less than 24h before inclusion * perineal scar with pain assessed as \> 3/10 with a numerical scale * 18-years-old or older * registration to the French medical system * speaking and writing French * written informed consent signed Exclusion Criteria: * woman under 18-years-old * woman under law liberty restriction * women unable to understand the written informed consent * no written informed consent signed * previous perineal surgery * delivery with a caesarian section * vaginal delivery with no perineal scar * vaginal delivery with infected perineal scar * women with restrictions for the use of level 1 analgesic * women requiring level 2 or 3 analgesics for other reasons

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Delivery complication Episiotomy Pain Perineal scars Treatment

Contacts and locations

Locations

  • CHU Amiens Picardie

    Amiens, Picardie, 80054, France

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