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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

Tracking Information
First Submitted Date October 2, 2022
First Posted Date October 5, 2022
Last Update Posted Date October 6, 2022
Estimated Study Start Date November 2022
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2022)
percent of breast lesions in pregnant and lactating females' [ Time Frame: 12 month ]
percent of breast lesions in pregnant and lactating females'
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
Official Title Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation
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 Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Preganat and Lactating Faemls
Intervention Device: ultrasound
screening of breast lesions by ultrasonography
Study Groups/Cohorts
  • lacating femals
    screening of breast lesions in lactating female
    Intervention: Device: ultrasound
  • pregnant
    screening of breast lesions in pregnant female
    Intervention: Device: ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 5, 2022)
50
Original Estimated Enrollment
 (submitted: October 2, 2022)
1000
Estimated Study Completion Date June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: heba G ahmed, resident doctor 01067986223 hebatallah_07649@med.sohag.edu.eg
Contact: Mohamed Z ali, professor 01001119166
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT05568628
Other Study ID Numbers Soh-Med-22-09-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Hebatallah Gamal Ahmed, Sohag University
Original Responsible Party Same as current
Current Study Sponsor Sohag University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Sohag University
Verification Date October 2022