Puncture Breast Abscess (PONCTABCESEIN)

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Abscess
• Intervention / Treatment: Behavioral: Phone call to the patient

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • AP-HP Hopital Necker Enfants malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women punctured for a breast lactant abscess in the center of Medical Imaging Duroc

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuation of breastfeeding	Phone call to the patient	1 week to 6 months after the puncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology of the abscess	Medical record and phone call to the patient	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	1 week to 6 months after the puncture
Relationship between puncture breastfeeding continuation	Medical record and phone call to the patient	1 week to 6 months after the puncture
Relationship between surgery and weaning	Medical record and phone call to the patient	1 week to 6 months after the puncture

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Virginie Rigourd, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 2, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: health; Breast feeding; puncture; breast abscess; ultrasound-guide
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: APHP18022; 2018-A02069-46 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No