Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Lanolin

Intervention Type OTHER

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

Group Type OTHER

Standard (usual) in-hospital and community postpartum care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No