Perineal ScarsMILTADoIPNCT05345600
MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
A study testing MILTA probe in people with Perineal Scars and Delivery Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Scars, Delivery Complication, Episiotomy
- What is being tested?
- MILTA probe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2022to 23 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.
The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.
This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.
- Conditions
- Perineal Scars, Delivery Complication, Episiotomy, Pain, Treatment
- Being tested
- MILTA probe, placebo probe
- Keywords
- Perineal scars, Delivery Complication, episiotomy, Pain, treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILTA probeOther
Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups ("MILTA" or "Placebo"): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the "analgesia mode" on followed with 5 min with the "healing mode" on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure.
placebo probeOther
Each woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups ("MILTA" or "Placebo"): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the "analgesia mode" on followed with 5 min with the "healing mode" on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| MILTA | Experimental | The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain Receives: Other: MILTA probe |
| placebo | Placebo comparator | Not described Receives: Other: placebo probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Pain Level will be determined with EQ-5D instrument. The EQ-5D index scores were derived from the current UK tariff, which has a maximum value of 1 and a minimum value of -0.59.
EQ-5D comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding.
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start31 Jan 2022
- Primary completion23 Mar 2023
- Study completion23 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal ScarsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345600
- Sponsor's protocol ID
- PI2021_843_0049
- Acronym
- MILTADoIP
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery
- ClinicalTrials.gov ID
- NCT05345600
- Acronym / sponsor ID
- MILTADoIP / PI2021_843_0049
- Conditions
- Perineal Scars, Delivery Complication, Episiotomy, Pain, Treatment
- Keywords
- Perineal scars, Delivery Complication, episiotomy, Pain, treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Nov 2025 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.
The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.
This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MILTA | Experimental | Other: MILTA probeThe MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain |
| placebo | Placebo comparator | Other: placebo probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILTA probeEach woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups ("MILTA" or "Placebo"): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the "analgesia mode" on followed with 5 min with the "healing mode" on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure. | Other | MILTA |
| placebo probeEach woman will be included within the 6h after delivery (to ensure at least 2 days with the treatment / placebo). Once the written informed consent is obtained, the patient will be randomized in one of the 2 groups ("MILTA" or "Placebo"): 2 sessions are planned (the first one between 6h and 24h after delivery and the second one day after the first session). The woman will be lying on an exam bed. After a skin cleansing, the MILTA probe covered with a specific single use protection will be placed facing the scar. A 10-min session will include 5 min with the "analgesia mode" on followed with 5 min with the "healing mode" on in the MILTA group. For the placebo group, the procedure will be identical, with the probe switched OFF. To ensure that the red light is observable in the bedroom in both groups, a second probe will be used, facing the ceiling of the exam bedroom (and not the woman) for the 10 minutes of the procedure. | Other | placebo |
Primary outcome
pain level
Time frame: day 3
Pain Level will be determined with EQ-5D instrument. The EQ-5D index scores were derived from the current UK tariff, which has a maximum value of 1 and a minimum value of -0.59. EQ-5D comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS) that are cognitively undemanding.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MILTA probe in people with Perineal Scars and Delivery Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.