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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153513
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Clinical Hospital Centre Zagreb
Information provided by (Responsible Party):
Olivera Perić, University of Mostar

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breastfeeding Drug: Lanolin Other: Mother's milk Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Comparison of the Effect of Lanolin and Breastmilk in the Treatment of Sore and Damaged Nipples in Breastfeeding Women- a Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Lanolin

Arm Intervention/treatment
Experimental: Lanolin Drug: 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).

Active Comparator: Mother's milk Other: 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).




Primary Outcome Measures :
  1. 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

  2. Nipple damage change [ Time Frame: baseline, 3 and 7 days post randomization ]

    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.



Secondary Outcome Measures :
  1. 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.

  2. Breastfeeding duration and exclusivity. [ Time Frame: 3 and 7 days post randomization, 3 and 6 months postpartum ]
    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.

  3. Satisfaction with proposed treatment [ Time Frame: 3 and 6 months postpartum ]
    The evaluation will be conducted by telephone interview with the Maternal Satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153513


Locations
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Bosnia and Herzegovina
Department of Gynecology and Obstetrics, University Clinical Hospital Mostar
Mostar, HNŽ, Bosnia and Herzegovina, 88000
Sponsors and Collaborators
University of Mostar
Clinical Hospital Centre Zagreb
Investigators
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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
Additional Information:
Publications of Results:
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Responsible Party: Olivera Perić, Olivera Perić MSc, Head nurse Department of Gynecology and Obstetrics, University of Mostar
ClinicalTrials.gov Identifier: NCT04153513    
Other Study ID Numbers: Study 2
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No