Therapeutic ultrasound treatment for women with inflammatory conditions of the lactating breast

Not Applicable

Recruiting

• Conditions: Breast engorgement; Lactational blocked ducts; Lactational mastitis; Breast abscess; Reproductive Health and Childbirth - Breast feeding; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12621000118808
• Lead Sponsor: eanda McKenna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-05
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 187

Inclusion Criteria

Lactating women over the age of 18, greater than 7 days postpartum, presenting with; a) at least 1 current local breast inflammatory symptom (e.g. breast pain, redness, increased temperature, swelling) AND b) at least 1 systemic inflammatory symptom (e.g. fever, chills, aching, lethargy, headache) this current episode.

Exclusion Criteria

History of breast cancer or breast surgery (including breast implants), pacemaker, preterm birth, multiple birth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Size of breast hardness area (in cm2), measured via tracing the area of hardness on to cling wrap with a permanent marker. Cling wrap tracings will be scanned into Adobe and the area calculated electronically. This measures area of local inflammatory symptoms.[ Timepoint 1: baseline (day 1, pre intervention). Timepoint 2: 1 day after intervention commencement (day 2, pre day 2 intervention). Timepoint 3: 2 days after intervention commencement (day 3, pre day 3 intervention) - primary timepoint. Timepoint 4: 10 days after intervention commencement.]