Breast AbscessPONCTABCESEINNCT03730467
Puncture Breast Abscess
An observational study of Breast Abscess, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess. The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Abscess
- What is being tested?
- Phone call to the patient
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2018to 4 Sep 2018
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc
Who may be able to join
- Nursing mothers
- Patients referred for breast abscesses during lactation
- Having an abscess confirmed ultrasoundly and indicating a puncture
- Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc
- Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone
- Women aged > 18 years old
- Women understanding French
- Affiliated to Social Security
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.
The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.
The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.
- Conditions
- Breast Abscess
- Being tested
- Phone call to the patient
- Keywords
- Breast feeding, breast abscess, ultrasound-guide, puncture, health
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call to the patientBehavioural
Phone call to the patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation of breastfeeding
Phone call to the patient
Measured: 1 week to 6 months after the puncture
Secondary outcomes (4)
Etiology of the abscess
Medical record and phone call to the patient
Measured: 1 week to 6 months after the puncture
Adequacy of medical care with the protocol of the Parisian Perinatal Health Network
Medical record and phone call to the patient
Measured: 1 week to 6 months after the puncture
Relationship between puncture breastfeeding continuation
Medical record and phone call to the patient
Measured: 1 week to 6 months after the puncture
Relationship between surgery and weaning
Medical record and phone call to the patient
Measured: 1 week to 6 months after the puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start4 Sep 2018
- Primary completion4 Sep 2018
- Study completion4 Sep 2018
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbscessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Virginie Rigourd, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730467
- Sponsor's protocol ID
- APHP180022
- Other IDs
- 2018-A02069-46
- Acronym
- PONCTABCESEIN
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2018
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures
- ClinicalTrials.gov ID
- NCT03730467
- Acronym / sponsor ID
- PONCTABCESEIN / APHP180022
- Conditions
- Breast Abscess
- Keywords
- Breast feeding, breast abscess, ultrasound-guide, puncture, health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 5 Nov 2018 (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.
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.
The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.
The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc
Key inclusion criteria (8 listed)
- Nursing mothers
- Patients referred for breast abscesses during lactation
- Having an abscess confirmed ultrasoundly and indicating a puncture
- Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc
- Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Phone call to the patientPhone call to the patient | Behavioural | – |
Primary outcome
Continuation of breastfeeding
Time frame: 1 week to 6 months after the puncture
Phone call to the patient
4 secondary outcomes
Etiology of the abscess
Time frame: 1 week to 6 months after the puncture
Adequacy of medical care with the protocol of the Parisian Perinatal Health Network
Time frame: 1 week to 6 months after the puncture
Relationship between puncture breastfeeding continuation
Time frame: 1 week to 6 months after the puncture
Relationship between surgery and weaning
Time frame: 1 week to 6 months after the puncture
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Virginie Rigourd, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Abscess, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Apr 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Continuation of breastfeeding (time frame: 1 week to 6 months after the puncture). 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 3 Apr 2026.