Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in 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

PHASE2

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-09-30

Brief Summary

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A randomized controlled study will be conducted at the accredited Baby Friendly Hospital in Mostar, Bosnia and Herzegovina. The study will include primiparas who have established breast feeding at the maternity ward and developed symptoms of painful and sore nipples within 72 hours from childbirth. Participants will be allocated in two groups and will receive education prior to the study.

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Detailed Description

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Recent studies show that early termination of breastfeeding is often associated with painful and sore nipples. Although health professionals recommend various treatments for painful and sore nipples, including alternative treatments, there is currently not enough evidence to recommend specific treatment of painful and sore nipples in lactating women. The primary objective of this study is to compare the effect of lanolin administration and the application of breast milk on the intensity of pain and healing of damaged nipples during breastfeeding. Subjects in the lanolin group will apply lanolin on each nipple and areola after each feeding while subjects in the breast milk group will apply several drops of milk on the nipple after each feed and allow them to air dry. In both groups, the treatment will last for 7 days or until the symptoms of pain and nipple damage have ceased. The main outcome measure is pain, which will be assessed through three time points and will be measured using an abridged version of the McGill Pain Questionnaire. Nipple damage will be assessed by means of a validated assessment tool, the Nipple trauma score. Secondary outcome measures will include breastfeeding efficacy, duration of any/exclusive breastfeeding, reasons for stopping breastfeeding and satisfaction with proposed treatment.The contribution of this study will be reflected in efficient treatment, better care of health professional in the prevention and treatment of damaged and sore nipples, and the study will also contribute in defining the guidelines for the development of procedure in midwifery practice for the treatment of painful and damaged nipples.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Participants will be randomly assigned to two study groups. An envelope containing a note, "mother's milk group" or "lanolin group" will be randomly distributed among women by a midwife who is not a part of the study. The participants will know which group they belong to. A single blind masking will be used during telephone data collection on day three and seven of treatment.

Study Groups

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Lanolin

Group Type EXPERIMENTAL

Lanolin

Intervention Type DRUG

Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Mother's milk

Group Type ACTIVE_COMPARATOR

Mother's milk

Intervention Type OTHER

After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Interventions

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Lanolin

Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Intervention Type DRUG

Mother's milk

After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primiparas who have given birth to infants born at full term at between 37-41 weeks gestation
* Mothers complaint of nipple pain with any sign of nipple trauma to one or both nipples,
* Access to telephone
* Signed Informed consent

Exclusion Criteria

* Primiparas with mental disorders
* Mothers allergy to lanolin
* Mothers with abnormal nipples
* Breast hypoplasia
* Infant with cleft palate
* Ankyloglossia
* Unsigned Informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No