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Clinical Trials/NCT05568628
NCT05568628
Not yet recruiting
Not Applicable

Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

Sohag University1 site in 1 country50 target enrollmentNovember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preganat and Lactating Faemls
Sponsor
Sohag University
Enrollment
50
Locations
1
Primary Endpoint
percent of breast lesions in pregnant and lactating females'
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer (PABC), which is too often diagnosed late Ultrasound is the first line breast imaging technique during pregnancy and lactation as Development of alveoli during pregnancy might not occur symmetrically, and these can be felt as focal nodularities, or even feel similar to masses, any suspicion of a mass should be assessed with US . If US illustrates glandular tissue and this correlates with the examiner presumption, no further work-up needs to be done. However, if presence of a mass is highly assumed, further follow-up by mammography, MRI and biopsy, when necessary, must be performed

Registry
clinicaltrials.gov
Start Date
November 2022
End Date
June 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hebatallah Gamal Ahmed

resident doctor at sohag cancer institute

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic

Exclusion Criteria

  • Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.

Outcomes

Primary Outcomes

percent of breast lesions in pregnant and lactating females'

Time Frame: 12 month

percent of breast lesions in pregnant and lactating females'

Study Sites (1)

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