Breast diseases in patients during pregnancy and lactation represent a unique diagnostic challenge due to the physiological changes that occur during these periods. The hormonal milieu, characterized by elevated estrogen, progesterone, and prolactin

Levels, leads to increased breast density, vascularity, and ductal activity. [1] These alterations can obscure the clinical and imaging findings, making the differentiation between benign and malignant lesions complex. Ultrasonography has emerged as the primary imaging modality in these patients because it is safe, non-ionizing, and capable of providing high-resolution images that delineate the internal architecture of the breast tissue. [2]

The spectrum of breast diseases encountered during pregnancy and lactation is broad. The most common conditions include fibroadenomas, which tend to enlarge during pregnancy due to hormonal influences, and lactational mastitis, which is often complicated by abscess formation. [3] Additionally, benign entities such as galactoceles and lactating adenomas are frequently observed. However, despite the increased prevalence of benign lesions, the potential for malignancy, though rare, necessitates a thorough and accurate evaluation. [4] Studies have demonstrated that the early detection of breast cancer in pregnant patients is critical for optimizing maternal and fetal outcomes, thereby underscoring the importance of ultrasonography as a diagnostic tool. [5]

Ultrasonography not only facilitates the detection of lesions but also provides valuable information about their composition, vascularity, and margins. This information is crucial in guiding the decision-making process regarding the need for further intervention, such as core needle biopsy or surgical excision. [6] The use of color Doppler imaging further enhances the evaluation by assessing the blood flow within a lesion, which can be an indicator of malignancy. [7] Moreover, recent advancements in ultrasound technology, including elastography, have improved the diagnostic accuracy by measuring tissue stiffness, thus offering an additional parameter for distinguishing benign from malignant lesions. [8]

Despite these advances, there remain limitations. The interpretation of ultrasound findings in the context of the physiological changes during pregnancy and lactation requires expertise, and inter-observer variability can affect diagnostic consistency. [9] Additionally, some lesions may still require further evaluation with magnetic resonance imaging (MRI) or histopathological confirmation to arrive at a definitive diagnosis. [10] In view of these challenges, it is imperative to adopt a standardized approach to ultrasonographic evaluation, incorporating both clinical and imaging criteria to optimize patient management.

This prospective study was conducted over a 12-month period in the Department of Radiology at a tertiary care center specializing in maternal and breast health.

Inclusion Criteria:

• Pregnant and lactating patients aged 18 years and above presenting with breast complaints such as palpable masses, pain, nipple discharge, or localized inflammation.
• Patients undergoing routine breast evaluation as part of prenatal or postnatal care who demonstrated any suspicious clinical findings.
• Patients willing to undergo follow-up imaging and, if indicated, histopathological sampling.

Exclusion Criteria:

• Patients with a history of breast malignancy or prior breast surgery, as these factors could alter the normal ultrasonographic appearance of the breast tissue.
• Patients with contraindications to ultrasonography, such as severe skin infections or open wounds over the breast area.
• Patients who refused consent for participation or follow-up.

Ultrasonographic Technique

High-frequency linear array transducers (7.5–15 MHz) were used for all examinations. Each patient underwent a detailed clinical history and physical examination prior to imaging. The ultrasound evaluation was performed in a systematic manner, ensuring comprehensive coverage of both breasts and the axillary regions. Standard gray-scale imaging was complemented by color Doppler studies to assess vascularity. In cases where further lesion characterization was required, elastography was also employed.

Data Collection

A standardized proforma was used to record patient demographics, clinical history, ultrasound findings, and any subsequent interventions. Lesions were characterized based on size, shape, margins, internal echo patterns, and posterior acoustic features. Color Doppler findings were noted, and elastographic strain ratios were calculated where applicable.

Follow-Up and Histopathological Correlation

Patients with suspicious lesions underwent ultrasound-guided core needle biopsy. All biopsy samples were sent for histopathological analysis to confirm the ultrasound diagnosis. Patients with benign findings were advised regular follow-up with repeat imaging at 3- to 6-month intervals to monitor any changes.

Statistical Analysis

The collected data were entered into a database and analyzed using appropriate statistical software. Descriptive statistics were used to summarize the demographics and clinical characteristics. The sensitivity, specificity, and predictive values of ultrasonography in differentiating benign from malignant lesions were calculated. The correlation between ultrasound findings and histopathological results was evaluated using chi-square tests, with a significance level set at p < 0.05.

Table 1. Demographic Characteristics of Patients

The largest proportion of patients falls within the 26–35 years age group (48%), aligning with the typical childbearing period where pregnancy and lactation are most common. The 18–25 years group comprises 28% of the patients. Patients aged 36–45 constitute 24% of the cohort, representing an older segment of the reproductive age group. Only 4% of the patients are above 45 years, suggesting that breast-related complaints during pregnancy and lactation are predominantly encountered in women of reproductive age.

Table 2. Distribution of Breast Diseases

In table 2, Fibroadenomas are the most common breast condition in this cohort, accounting for 36% of cases. Lactational mastitis follows closely with 32%, highlighting the commonality of this condition in lactating women. Abscesses, occurring in 12% of patients, are often secondary to untreated mastitis. Galactoceles are seen in 8%, a benign condition resulting from blocked milk ducts during lactation. Lactating adenomas, accounting for 6%, are benign tumors that may develop as a response to hormonal changes during pregnancy and lactation. Malignancies, though less prevalent at 6%, underline the importance of vigilant detection and differentiation of benign lesions from potentially malignant ones. for 4 seconds

Table 3. Ultrasonographic Features

Table 4. Pregnancy-Related Ultrasound Findings

Diffuse parenchymal enhancement (50 cases) is a common finding during pregnancy and lactation, reflecting the normal hormonal effect of increased estrogen and prolactin levels, which enhance breast tissue vascularity and density. Increased vascularity (40 cases) observed on ultrasound is often associated with inflammatory conditions such as mastitis.

Figure 1:  Larger breast size and

increased density of parenchyma                                             Figure 2: Galactocele

Table 5. Lactation-Related Ultrasound Findings

Ductal ectasia (25 cases) is common in lactating breasts due to hormonal effects, where breast ducts can enlarge or become dilated. Cystic changes (20 cases) particularly galactoceles, are a common benign finding during lactation. Abscess formation (15 cases) typically associated with mastitis, are indicative of an infectious process.

Figure 3:  Increased echogenicity with ductal prominence

Table 6. Correlation Between Ultrasound and Histopathological Diagnosis

Benign Lesions (concordance 98%) are high concordance rate (98%) between ultrasound diagnosis and histopathological confirmation for benign lesions demonstrates that ultrasonography is highly accurate in identifying benign breast conditions such as fibroadenomas and galactoceles. Malignant Lesions (concordance 70%) malignant lesions demonstrated a lower level of agreement between ultrasound findings and histopathological results. Inconclusive (no concordance data) are labeled as inconclusive indicate situations where ultrasound findings were not definitive in categorizing the lesion as either benign or malignant. 

The current study highlights the critical role of ultrasonography in the evaluation of breast diseases during pregnancy and lactation. Ultrasonography is particularly valuable in this population because it avoids the risks associated with ionizing radiation while providing real-time, high-resolution imaging. In our series, the majority of lesions were benign, with fibroadenomas and lactational mastitis representing the most common pathologies. These findings are consistent with previous reports, which have noted that the hormonal changes during pregnancy and lactation predispose women to benign proliferative processes. [11]

One of the key advantages of ultrasonography is its ability to characterize lesions based on morphology. In this study, lesions with well-defined margins and homogeneous internal echoes were predominantly benign. Conversely, lesions with irregular margins and heterogeneous echotexture raised suspicion for malignancy. Although the overall sensitivity and specificity for detecting malignancy were high in benign cases, the diagnostic accuracy for malignant lesions was somewhat lower, as reflected in the 70% concordance rate with histopathology. This discrepancy underscores the importance of integrating ultrasound findings with clinical judgment and, when necessary, proceeding to tissue sampling for definitive diagnosis. [12]

Color Doppler imaging enhanced the evaluation by providing additional information on lesion vascularity. Increased vascularity was commonly observed in inflammatory conditions such as mastitis and abscess formation. However, hypervascularity can also be seen in malignant tumors, which necessitates careful interpretation. Recent advancements, such as ultrasound elastography, have further refined the ability to differentiate between benign and malignant lesions by assessing tissue stiffness. While elastography was not universally applied in all cases within this study, its potential benefits warrant further investigation in larger cohorts. [13]

The study also emphasizes the need for a standardized protocol in the ultrasonographic evaluation of breast diseases during pregnancy and lactation. Adherence to strict inclusion and exclusion criteria ensured that the study population was representative of the clinical scenario. The systematic use of high-frequency transducers and standardized scanning protocols contributed to the reliability of the findings. Nonetheless, inter-observer variability remains a challenge. Regular training and consensus meetings among radiologists can mitigate these discrepancies and enhance diagnostic accuracy. [14]

An important aspect of this research was the correlation of ultrasound findings with histopathological results. Although most benign lesions were accurately diagnosed using ultrasound, a subset of patients with suspicious features underwent biopsy for confirmation. The lower concordance observed in malignant cases highlights a limitation of ultrasonography in differentiating malignancy in a background of hormonal changes. Therefore, a multidisciplinary approach involving radiologists, pathologists, and clinicians is essential for optimal patient management. [15]

Ultrasonography remains the cornerstone in the evaluation of breast diseases in pregnant and lactating patients. Its ability to safely distinguish between benign and potentially malignant lesions significantly aids in early diagnosis and management. While benign lesions predominate, the careful interpretation of ultrasonographic features, coupled with clinical correlation and histopathological confirmation when indicated, is essential for optimal patient care. Continued advances in ultrasound technology and standardized imaging protocols are expected to further enhance diagnostic accuracy and improve patient outcomes.

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