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Completed

NCT Number: NCT01420419

Evaluating Lanolin for the Treatment of Nipple Pain Among Breastfeeding Women

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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Key information

Conditions

Pain Behavior Breast Feeding Feeding Behavior Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Postpartum Unit St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lanolin

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 (usual) in-hospital and community postpartum care

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.

Primary outcomes

  1. Nipple pain severity

    Time frame: 4 days post randomization

    Measured with a 10-point numeric rating scale (NRS)

Secondary outcomes

  1. Breastfeeding duration

    Time frame: 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.

  2. Breastfeeding exclusivity

    Time frame: 4 and 12 weeks postpartum

    Measured with Labbok & Krasovek's framework for breastfeeding definition (Studies in Family Planning, 1990;21(4),226-230)

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Acronym: LanP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2011
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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