Painful BreastfeedingAMATOSTEONCT05185323
Painful Breastfeeding and Osteopathic Treatment on the Mother-newborn Dyad
A study testing Breastfeeding usual known aids and osteopathic treatment and Breastfeeding usual known aids in people with Painful Breastfeeding, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. Read more about this study
- Who is it for?
- Ages 3 days and older, women only
- Conditions the study is for
- Painful Breastfeeding
- What is being tested?
- Breastfeeding usual known aids and osteopathic treatment and Breastfeeding usual known aids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to 12 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 days and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother 18 yrs and older who chose to breast-feed (exclusive or not)
- Singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life
- Pain during lactation greater than 7 (scale 0 to 10) in one or both breasts
- Usual known aids ineffective to reduce pain during lactation
- Mother speaking and understanding French
- Mother affiliated or beneficiary to a health system
- Signed informed consent.
Who cannot join
- Medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders)
- Severe congenitale malformation, especially not allowing normal lactation
- Patient under legal protection
- Persons deprived of their liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Osteopathic Treatment on the Mother-newborn Dyad in the Event of Painful Breastfeeding in the Maternity Hospital Despite the Application of All Usual Aids: Randomized Interventional Study in Clusters in Two Parallel Arms Without Blinding. AMATOSTEO
Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth
Read the detailed description
Breastfeeding is recognized to be essential for childhood health and public health. The first reason to stop breastfeeding before the second month after birth is pain during lactation. The second reason to stop breastfeeding is back-to-work, generally two months after birth. Few years ago, osteopathic treatment has been introduced at maternity hospital of Bordeaux when usual known aids are ineffective. The osteopathic treatment is completely integrated in the maternity hospital of Bordeaux but no strong evaluation is available in literature. A pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) Breast pain decreased or disappeared after the osteopathic treatment. Another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. In the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). The experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). Among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.
- Conditions
- Painful Breastfeeding
- Being tested
- Breastfeeding usual known aids and osteopathic treatment, Breastfeeding usual known aids
- Keywords
- Osteopathic manipulative treatment, pain, breastfeeding
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding usual known aids and osteopathic treatmentOther
Breastfeeding usual known aids and osteopathic treatment
Breastfeeding usual known aidsOther
Breastfeeding usual known aids
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding usual known aids and osteopathic treatment | Experimental | The osteopathic treatment consists of manual listening without intention, without thrust. The hands follow the spontaneous movements of the patients. The end of the treatment is perceived by an overall relief and a feeling of balance for the baby and his mother Receives: Other: Breastfeeding usual known aids and osteopathic treatment |
| Breastfeeding usual known aids | Active comparator | Breastfeeding usual known aids in usual care Receives: Other: Breastfeeding usual known aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women still breastfeeding
Proportion of women still breastfeeding even if not exclusive
Measured: 1 month after birth
Secondary outcomes (4)
Pain during lactation
Pain at each breast during lactation after osteopathic treatment (analogic visual evaluation from 0-no pain to 10-extreme pain)
Measured: 7 days, 1 month
breastfeeding
Proportion of women still breastfeeding even if not exclusive
Measured: 7 days, 1 month
Proportion of women still exclusive breastfeeding
Proportion of women still exclusive breastfeeding
Measured: 1 month
Amount of artificial milk given per day
Amount of artificial milk given per day
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Mar 2022
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful BreastfeedingStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185323
- Sponsor's protocol ID
- CHUBX 2018/38
- Acronym
- AMATOSTEO
- Status last verified
- May 2024
- First submitted
- 1 Dec 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elleau C, Missmahl C, Belcadi W, Aurillac-Lavignolle V, Sentilhes L. Evaluation of the effectiveness of osteopathic treatment on the mother-newborn dyad in the event of painful breastfeeding in a maternity hospital despite the application of all usual aids: randomized interventional trial in two parallel arms without blinding. Front Nutr. 2025 Apr 24;12:1577502. doi: 10.3389/fnut.2025.1577502. eCollection 2025.
PubMed 40342372
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Osteopathic Treatment on the Mother-newborn Dyad in the Event of Painful Breastfeeding in the Maternity Hospital Despite the Application of All Usual Aids: Randomized Interventional Study in Clusters in Two Parallel Arms Without Blinding. AMATOSTEO
- ClinicalTrials.gov ID
- NCT05185323
- Acronym / sponsor ID
- AMATOSTEO / CHUBX 2018/38
- Conditions
- Painful Breastfeeding
- Keywords
- Osteopathic manipulative treatment, pain, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 11 Jan 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.
Pain during lactation is the first reason to stop breastfeeding. When usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. The aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. The primary outcome is the lactation rate (exclusive or partial) at 1 month after birth
Detailed description
Breastfeeding is recognized to be essential for childhood health and public health. The first reason to stop breastfeeding before the second month after birth is pain during lactation. The second reason to stop breastfeeding is back-to-work, generally two months after birth. Few years ago, osteopathic treatment has been introduced at maternity hospital of Bordeaux when usual known aids are ineffective. The osteopathic treatment is completely integrated in the maternity hospital of Bordeaux but no strong evaluation is available in literature. A pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) Breast pain decreased or disappeared after the osteopathic treatment. Another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. In the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). The experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). Among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding usual known aids and osteopathic treatment | Experimental | Other: Breastfeeding usual known aids and osteopathic treatmentThe osteopathic treatment consists of manual listening without intention, without thrust. The hands follow the spontaneous movements of the patients. The end of the treatment is perceived by an overall relief and a feeling of balance for the baby and his mother |
| Breastfeeding usual known aids | Active comparator | Other: Breastfeeding usual known aidsBreastfeeding usual known aids in usual care |
Who may qualify
- Ages
- 3 days and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Mother 18 yrs and older who chose to breast-feed (exclusive or not)
- Singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life
- Pain during lactation greater than 7 (scale 0 to 10) in one or both breasts
- Usual known aids ineffective to reduce pain during lactation
- Mother speaking and understanding French
Key exclusion criteria (4 listed)
- Medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders)
- Severe congenitale malformation, especially not allowing normal lactation
- Patient under legal protection
- Persons deprived of their liberty by judicial or administrative decision
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 |
|---|---|---|
| Breastfeeding usual known aids and osteopathic treatmentBreastfeeding usual known aids and osteopathic treatment | Other | Breastfeeding usual known aids and osteopathic treatment |
| Breastfeeding usual known aidsBreastfeeding usual known aids | Other | Breastfeeding usual known aids |
Primary outcome
Proportion of women still breastfeeding
Time frame: 1 month after birth
Proportion of women still breastfeeding even if not exclusive
4 secondary outcomes
Pain during lactation
Time frame: 7 days, 1 month
breastfeeding
Time frame: 7 days, 1 month
Proportion of women still exclusive breastfeeding
Time frame: 1 month
Amount of artificial milk given per day
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 40342372Elleau C, Missmahl C, Belcadi W, Aurillac-Lavignolle V, Sentilhes L. Evaluation of the effectiveness of osteopathic treatment on the mother-newborn dyad in the event of painful breastfeeding in a maternity hospital despite the application of all usual aids: randomized interventional trial in two parallel arms without blinding. Front Nutr. 2025 Apr 24;12:1577502. doi: 10.3389/fnut.2025.1577502. eCollection 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 Breastfeeding usual known aids and osteopathic treatment and Breastfeeding usual known aids in people with Painful Breastfeeding, run by University Hospital, Bordeaux 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 17 May 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of women still breastfeeding (time frame: 1 month after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185323, which also lists 1 linked publication.
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 17 May 2024.