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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cindy-Lee Dennis, University of Toronto
ClinicalTrials.gov Identifier:
NCT01420419
First received: March 29, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Pain
Other: Lanolin
Other: Standard (usual) in-hospital and community postpartum care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Nipple pain severity [ Time Frame: 4 days post randomization ] [ Designated as safety issue: No ]
    Measured with a 10-point numeric rating scale (NRS)


Secondary Outcome Measures:
  • Breastfeeding duration [ Time Frame: 4 and 12 weeks postpartum ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)


Enrollment: 186
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420419

Locations
Canada, Ontario
Postpartum Unit St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Cindy-Lee Dennis, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Cindy-Lee Dennis, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01420419     History of Changes
Other Study ID Numbers: 26044
Study First Received: March 29, 2011
Last Updated: January 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
nipple pain
breastfeeding
nipple damage
lanolin
clinical trial

ClinicalTrials.gov processed this record on November 25, 2014