Puncture Breast Abscess

Breast Abscess Clinical Trial

— PONCTABCESEIN  

Official title:

Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03730467
• Other study ID #: APHP18022
• Secondary ID: 2018-A02069-46
• Status: Withdrawn
• Start date: December 2018
• Est. completion date: December 2018

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Breast Abscess

Intervention

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

Locations

Country	Name	City	State
France	AP-HP Hopital Necker Enfants malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation of breastfeeding	Phone call to the patient	1 week to 6 months after the puncture
Secondary	Etiology of the abscess	Medical record and phone call to the patient	1 week to 6 months after the puncture
Secondary	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
Secondary	Relationship between puncture breastfeeding continuation	Medical record and phone call to the patient	1 week to 6 months after the puncture
Secondary	Relationship between surgery and weaning	Medical record and phone call to the patient	1 week to 6 months after the puncture