Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women (LanP)
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|ClinicalTrials.gov Identifier: NCT01420419|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : January 16, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Lanolin Other: Standard (usual) in-hospital and community postpartum care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
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
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.
Standard postpartum nursing care
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
Other: Standard (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.
- Nipple pain severity [ Time Frame: 4 days post randomization ]Measured with a 10-point numeric rating scale (NRS)
- Breastfeeding duration [ Time Frame: 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 [ Time Frame: 4 and 12 weeks postpartum ]Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420419
|Postpartum Unit St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Cindy-Lee Dennis, PhD||University of Toronto|
|Responsible Party:||Cindy-Lee Dennis, Professor, University of Toronto|
|Other Study ID Numbers:||
|First Posted:||August 19, 2011 Key Record Dates|
|Last Update Posted:||January 16, 2013|
|Last Verified:||January 2013|