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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanolin | Experimental | Pea sized amount of lanolin to be applied to nipple and areola after every breast feed (approximately every 2-3 hours), until pain is completely resolved for a maximum of 7 days |
|
| Standard postpartum nursing care | Other | Women in standard care control group may receive any other nursing intervention to manage their nipple pain, including (but not limited to): recommending application of expressed breast milk, analgesics (such as acetaminophen or ibuprofen), breast shells, air drying, changing position / latch, cold or warm compresses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanolin | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Nipple pain severity | Measured with a 10-point numeric rating scale (NRS) | 4 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding duration | 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. | 4 and 12 weeks postpartum |
| Breastfeeding exclusivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy-Lee Dennis, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postpartum Unit St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
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| ID | Term |
|---|---|
| D007809 | Lanolin |
| D006761 | Hospitals |
| ID | Term |
|---|---|
| D014885 | Waxes |
| D008055 | Lipids |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| Standard (usual) in-hospital and community postpartum care | Other | 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. |
|
Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230) |
| 4 and 12 weeks postpartum |
| D001519 | Behavior |