Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women
Phase 4
Completed
- Conditions
- Pain
- Registration Number
- NCT01420419
- Lead Sponsor
- University of Toronto
- Brief Summary
The purpose of this study is to evaluate the effectiveness of lanolin for the treatment of painful/damaged nipples among breastfeeding women, and to evaluate if the use of lanolin has an effect on breastfeeding outcomes such as duration and exclusivity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 186
Inclusion Criteria
- Maternal complaint of nipple pain with any sign of nipple trauma to one or both nipples, such as blistering, crusting, redness, bleeding, swelling, cracking, discoloration or peeling.
- Infant delivered at, or greater than 37 weeks gestation.
- Singleton birth.
- Speaks and understands English.
- Access to telephone.
Exclusion Criteria
- Infant not expected to be discharged home with mother.
- Infant with congenital abnormalities that would impair breastfeeding.
- Maternal allergy to lanolin.
- Maternal health conditions that may interfere with breastfeeding (physical or mental illness) as determined by hospital staff.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Nipple pain severity 4 days post randomization Measured with a 10-point numeric rating scale (NRS)
- Secondary Outcome Measures
Name Time Method Breastfeeding duration 4 and 12 weeks postpartum Measured by asking women the last time their infant was breastfed. Breastfeeding duration will be calculated as the difference between the infant's date of birth, and the last day (date) the infant was breastfed.
Breastfeeding exclusivity 4 and 12 weeks postpartum Measured with Labbok \& Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)
Trial Locations
- Locations (1)
Postpartum Unit St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Postpartum Unit St. Joseph's Healthcare Hamilton🇨🇦Hamilton, Ontario, Canada