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Puncture Breast Abscess (PONCTABCESEIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03730467
Recruitment Status : Not yet recruiting
First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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.


Condition or disease Intervention/treatment
Breast Abscess Behavioral: Phone call to the patient

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Phone call to the patient
    Phone call to the patient


Primary Outcome Measures :
  1. Continuation of breastfeeding [ Time Frame: 1 week to 6 months after the puncture ]
    Phone call to the patient


Secondary Outcome Measures :
  1. Etiology of the abscess [ Time Frame: 1 week to 6 months after the puncture ]
    Medical record and phone call to the patient

  2. Adequacy of medical care with the protocol of the Parisian Perinatal Health Network [ Time Frame: 1 week to 6 months after the puncture ]
    Medical record and phone call to the patient

  3. Relationship between puncture breastfeeding continuation [ Time Frame: 1 week to 6 months after the puncture ]
    Medical record and phone call to the patient

  4. Relationship between surgery and weaning [ Time Frame: 1 week to 6 months after the puncture ]
    Medical record and phone call to the patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

No


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730467


Contacts
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Contact: Virginie Rigourd, MD 01 71 19 60 48 virginie.rigourd@aphp.fr
Contact: Hélène Morel 01 71 19 63 46 helene.morel@aphp.fr

Locations
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France
AP-HP Hopital Necker Enfants malades
Paris, France, 75015
Contact: Virginie Rigourd, MD    01 71 19 60 48    virginie.rigourd@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Virginie Rigourd, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03730467    
Other Study ID Numbers: APHP18022
2018-A02069-46 ( Registry Identifier: ID RCB )
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Breast feeding
breast abscess
ultrasound-guide
puncture
health
Additional relevant MeSH terms:
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Abscess
Suppuration
Infection
Inflammation
Pathologic Processes