Puncture Breast Abscess | NCT03730467

Studies
Puncture Breast Abscess

NCT03730467

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Apr 3, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Abscess

Interventions

Phone call to the patient

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A02069-46	Registry Identifier	ID RCB

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study halted prematurely, prior to enrollment of first participant

Expanded Access Info

Start Date

Sep 4, 2018Actual

Primary Completion Date

Sep 4, 2018Actual

Completion Date

Sep 4, 2018Actual

First Submitted Date

Nov 2, 2018

First Submission Date that Met QC Criteria

Nov 2, 2018

First Posted Date

Nov 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2026

Last Update Posted Date

Apr 3, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Phone call to the patient	Behavioral	Phone call to the patient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virginie Rigourd, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AP-HP Hopital Necker Enfants malades		Paris		75015	France

ID	Term
D005247	Feeding Behavior
D001519	Behavior