Pain
Conditions
Keywords
nipple pain, breastfeeding, nipple damage, lanolin, clinical trial
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.
Interventions
OTHERLanolin
Pea-sized amount of lanolin applied to each nipple after every breastfeeding session (approximately 8-12 times daily) until complete resolution of nipple pain and damage for a maximum of 7 days.
OTHERStandard (usual) in-hospital and community postpartum care
Women randomized to standard care will not receive lanolin or information regarding how to use lanolin. In-hospital standard care may include any of the following pain management measures at the recommendation / discretion of the participant's health care provider, or based on the patient's personal preference: analgesics (such as ibuprofen or acetaminophen); application of cold or warm compresses; application of ice packs; use of breast shields; air drying the nipples; or applying expressed breast milk.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nipple pain severity | 4 days post randomization | Measured with a 10-point numeric rating scale (NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada
Outcome results
None listed