- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153513
Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women
Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
HNŽ
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Mostar, HNŽ, Bosnia and Herzegovina, 88000
- Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lanolin
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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).
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Active Comparator: Mother's milk
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nipple pain severity
Time Frame: baseline, 3 and 7 days post randomization
|
An abbreviated version of the McGill Questionnaire (SF-MPQ) will be used to assess the intensity of nipple pain.
For the assessment of the current intensity of pain in the nipples will be used subcategories SF-MPQ, the current assessment of pain (PPI).
It consists of a verbal scoring scale with values from 0 to 5, 0= No pain, 1= Mild, 2 = Discomforting, 3= Distressing, 4= Horrible, 5= Excruciating
|
baseline, 3 and 7 days post randomization
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Nipple damage change
Time Frame: baseline, 3 and 7 days post randomization
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The baseline assessment of nipple damage will be performed by a validated Nipple Trauma Score (NST). The assessment is performed on scales from 0 to 5 where 0 = no macroscopically visible changes in the skin, 1 = erythema or edema or a combination of both, 2 = superficial damage or no scab on <25% of the nipple surface, 3 = superficial damage with or without scab on> 25% of nipple surface, 4 = partial thickness wound with or without scab on <25% of nipple surface, 5 = partial thickness with or without scab on> 25% of nipple surface. Three and 7 days after applying the treatment, the condition of the nipple will be evaluated with a Questionnaire on Pain and Damage to the Nipple, where a telephone survey will be performed by the Principal Investigator in order to describe and compare the condition of the nipples. |
baseline, 3 and 7 days post randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of breastfeeding self-efficacy
Time Frame: baseline, 3 and 7 days post randomization
|
Breastfeeding self-efficacy will be evaluated by a validated version of the Self-Efficacy Scale-Short Form (BSES-SF).
The scale consists of 14 items, with the offered five statements on the Likert scale, from strongly disagree to strongly agree.
The sum of grades ranges from 14 to 70, the higher the sum the greater the efficiency of breastfeeding.
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baseline, 3 and 7 days post randomization
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Breastfeeding duration and exclusivity.
Time Frame: 3 and 7 days post randomization, 3 and 6 months postpartum
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The way of feeding of the baby in the last 24 hours will be evaluated by the World Health Organization (WHO) breastfeeding categories.
The assessment will be conducted through a telephone interview with her mother.
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3 and 7 days post randomization, 3 and 6 months postpartum
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Satisfaction with proposed treatment
Time Frame: 3 and 6 months postpartum
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The evaluation will be conducted by telephone interview with the Maternal Satisfaction
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3 and 6 months postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Olivera Perić, VII, Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
- Study Chair: Anita Pavičić Bošnjak, VII, Clinical Hospital Centre Zagreb
- Study Chair: Vajdana Tomić, VII, Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
Publications and helpful links
General Publications
- Pavicic Bosnjak A, Rumboldt M, Stanojevic M, Dennis CL. Psychometric assessment of the croatian version of the breastfeeding self-efficacy scale-short form. J Hum Lact. 2012 Nov;28(4):565-9. doi: 10.1177/0890334412456240. Epub 2012 Sep 6.
- Abou-Dakn M, Fluhr JW, Gensch M, Wockel A. Positive effect of HPA lanolin versus expressed breastmilk on painful and damaged nipples during lactation. Skin Pharmacol Physiol. 2011;24(1):27-35. doi: 10.1159/000318228. Epub 2010 Aug 18.
- Peric O, Pavicic Bosnjak A, Mabic M, Tomic V. Comparison of Lanolin and Human Milk Treatment of Painful and Damaged Nipples: A Randomized Control Trial. J Hum Lact. 2022 Nov 18:8903344221135793. doi: 10.1177/08903344221135793. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Study 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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