Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Pain Clinical Trial

— LanP  

Official title:

A Randomized Controlled Trial Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420419
• Other study ID #: 26044
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: January 14, 2013
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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 (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.

Locations

Country	Name	City	State
Canada	Postpartum Unit St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nipple pain severity	Measured with a 10-point numeric rating scale (NRS)	4 days post randomization	No
Secondary	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	No
Secondary	Breastfeeding exclusivity	Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)	4 and 12 weeks postpartum	No