Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Phase 4

Completed

• Conditions: Pain
• Interventions: Other: Lanolin; Other: Standard (usual) in-hospital and community postpartum care

• Registration Number: NCT01420419
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-29
• Study Start: 2011-05
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lanolin	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
Standard postpartum nursing care	Standard (usual) in-hospital and community postpartum 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

Primary Outcome Measures

Name	Time	Method
Nipple pain severity	4 days post randomization	Measured with a 10-point numeric rating scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Breastfeeding duration	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	4 and 12 weeks postpartum	Measured with Labbok \& Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)

Trial Locations

Locations (1)

Postpartum Unit St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada