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Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women (LanP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01420419
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : January 16, 2013
Sponsor:
Information provided by (Responsible Party):
Cindy-Lee Dennis, University of Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Other: Lanolin Other: Standard (usual) in-hospital and community postpartum care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lanolin
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
 Other: Lanolin
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.


Outcome Measures
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Primary Outcome Measures :
  1. Nipple pain severity [ Time Frame: 4 days post randomization ]
    Measured with a 10-point numeric rating scale (NRS)


Secondary Outcome Measures :
  1. 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.

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Postpartum Unit St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Cindy-Lee Dennis, PhD University of Toronto
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Cindy-Lee Dennis, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01420419    
Other Study ID Numbers: 26044
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by Cindy-Lee Dennis, University of Toronto:
nipple pain
breastfeeding
nipple damage
lanolin
clinical trial