Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

Not yet recruiting

• Conditions: Preganat and Lactating Faemls
• Interventions: Device: ultrasound

• Registration Number: NCT05568628
• Lead Sponsor: Sohag University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-02
• Study First Posted: 2022-10-05
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06
• Study Start: 2022-11
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lacating femals	ultrasound	screening of breast lesions in lactating female
pregnant	ultrasound	screening of breast lesions in pregnant female

Primary Outcome Measures

Name	Time	Method
percent of breast lesions in pregnant and lactating females'	12 month	percent of breast lesions in pregnant and lactating females'

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt