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

University of Toronto

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Other: Lanolin; Other: Standard (usual) in-hospital and community postpartum care

Study type: Interventional

Funder types: Other

Identifiers

NCT01420419

26044

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Lanolin

Experimental group

Description:

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

Treatment:

Other: Lanolin

Standard postpartum nursing care

Other group

Description:

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

Treatment:

Other: Standard (usual) in-hospital and community postpartum care