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Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

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ClinicalTrials.gov Identifier: NCT05568628
Recruitment Status : Not yet recruiting
First Posted : October 5, 2022
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Hebatallah Gamal Ahmed, Sohag University

Study Description
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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

Condition or disease Intervention/treatment
Preganat and Lactating Faemls Device: ultrasound

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
lacating femals
screening of breast lesions in lactating female
 Device: ultrasound
screening of breast lesions by ultrasonography
pregnant
screening of breast lesions in pregnant female
 Device: ultrasound
screening of breast lesions by ultrasonography


Outcome Measures
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Primary Outcome Measures :
  1. percent of breast lesions in pregnant and lactating females' [ Time Frame: 12 month ]
    percent of breast lesions in pregnant and lactating females'


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
- 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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568628


Contacts
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Contact: heba G ahmed, resident doctor 01067986223 hebatallah_07649@med.sohag.edu.eg
Contact: Mohamed Z ali, professor 01001119166

Locations
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Egypt
Sohag University Hospital
Sohag, Egypt
Contact: Magdy M Amin, professor         
Sponsors and Collaborators
Sohag University
More Information
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Publications:

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Responsible Party: Hebatallah Gamal Ahmed, resident doctor at sohag cancer institute, Sohag University
ClinicalTrials.gov Identifier: NCT05568628    
Other Study ID Numbers: Soh-Med-22-09-01
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No