Continuous ultrasound diathermy combined with conventional therapies versus conventional therapies alone for breast engorgement in postpartum lactating women: a randomized controlled study
Phase 1
- Conditions
- Immediate postpartum breast engorgementPostpartum blocked ductBreastfeeding patientsPain managementEngorgementLevel of difficulty breastfeedingDuration of breastfeedingImmediate postpartum breast engorgementPostpartum blocked ductBreastfeeding patientsPain managementEngorgementLevel of difficulty breastfeedingDuration of breastfeedingUltrasound diather
- Registration Number
- TCTR20181123001
- Lead Sponsor
- Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- Female
- Target Recruitment
- 72
Inclusion Criteria
1. Breastfeeding patients
2. Postpartum breast engorgement and blocked duct (diagnosed by latational specialist nurses)
Exclusion Criteria
1. Mastitis/ Breast abscess/ Abnormal ultrasound findings suggest malignancy (excluded by diagnostic breast ultrasound by radiologist)
2. Family history of breast cancer (first degree)
3. Previous history of breast implant or augmentation
4. Accessory breast
5. History of previous ultrasound diathermy treatment
6. Impaired sensation in breast area
7. Impaired Thai language communication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The level of Pain Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter)
- Secondary Outcome Measures
Name Time Method Hardness Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patient,Level of difficulty breastfeeding Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Visual analog scale (millimeter), rated by patien,Breast engorgement severity (assessed by physician ) Pre-1st treatment, Post-1st treatment and Post 3rd (last) treatment Humenick Six-point engorgement scale ,Duration of breastfeeding post treatment days,Complication: mastitis, breast abscess post treatment number of complication