Applying Breast Mask Containing Cabbage Leaves Extract to Relieve Breast Discomfort in Breastfeeding Women (BMCCLE)

Taipei Veterans General Hospital

Status: Not yet enrolling

Conditions: Breast Engorgement

Treatments: Combination Product: Sham Comparator; Combination Product: Experimental: breast mask containing cabbage leaves extract group

Study type: Interventional

Funder types: Other

Identifiers

NCT07017894

ACIC-114-005 (Other Identifier)

2025-04-009A

Details and patient eligibility

About

In this article, women were randomly assigned to the Breast Mask Containing Cabbage Leaves Extract group and Breast Mask without Cabbage Leaves Extract group, and the breast engorgement, pain, hardness, before and after each treatment were measured. At the end of the study breast mask user experience and continued breastfeeding were measured.

Full description

Breast engorgement as the swelling and distention of breast, which is one of the most common problems often occurs 2-4 days after delivery, resulting in pain and fever, which reduces the intention of mothers to continue breastfeeding and causes to stop breastfeeding in the early postpartum period.

There are many conservative treatments for relieving breast engorgement. At present, there have been published studies on the application of medications, cold compresses, warm compresses, massages, gua sha and cabbage leaves compression to breast problems during lactation. Previous studies have shown that cabbage leaves compression can relieve the breast engorgement, pain, and hardness of postpartum women. However, safety concerns related to freshness, preservation, and residual pesticides must be considered when using cabbage leaves in a clinical setting. The purpose of this study was to examine whether breast mask containing cabbage leaves extract can improve breast engorgement, pain, and hardness.

Enrollment: 154 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 years old.
• Breastfeeding.
• Physiological breast swelling, breast heaviness, lumps, milk plugging, breast pain after childbirth.
• Able to read and understand Chinese.

Exclusion criteria

• Stillbirth
• Allergy to cabbage or sulfa.
• lactation inhibitors agents used.
• Fever symptoms (> 38 degrees Celsius), including: wound infection, upper respiratory tract infection, urinary tract infection.
• Breast symptoms, including: nipple cracks, skin damage, breast abscesses, mastitis, Malignant tumors.
• Postpartum complications, including: postpartum hemorrhage, amniotic fluid embolism or other diseases requiring close care.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 2 patient groups

breast mask containing cabbage leaves extract group

Experimental group

Description:

Apply the breast mask containing cabbage leaf extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.

Treatment:

Combination Product: Experimental: breast mask containing cabbage leaves extract group

breast mask without cabbage leaves extract group

Sham Comparator group

Description:

Apply a breast mask without cabbage leaves extract to the breasts, avoiding the nipples, for 20 minutes, 2 times a day, for 3 days.

Treatment:

Combination Product: Sham Comparator