NCT03730467

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2024

Enrollment Period

Same day

First QC Date

November 2, 2018

Last Update Submit

November 17, 2025

Conditions

Keywords

Breast feedingbreast abscessultrasound-guidepuncturehealth

Outcome Measures

Primary Outcomes (1)

  • Continuation of breastfeeding

    Phone call to the patient

    1 week to 6 months after the puncture

Secondary Outcomes (4)

  • Etiology of the abscess

    1 week to 6 months after the puncture

  • Adequacy of medical care with the protocol of the Parisian Perinatal Health Network

    1 week to 6 months after the puncture

  • Relationship between puncture breastfeeding continuation

    1 week to 6 months after the puncture

  • Relationship between surgery and weaning

    1 week to 6 months after the puncture

Interventions

Phone call to the patient

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Hopital Necker Enfants malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Virginie Rigourd, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 5, 2018

Study Start

September 4, 2018

Primary Completion

September 4, 2018

Study Completion

September 4, 2018

Last Updated

November 20, 2025

Record last verified: 2024-10

Locations