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The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack

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: NCT04259320
Recruitment Status : Completed
First Posted : February 6, 2020
Last Update Posted : October 25, 2021
Istanbul University - Cerrahpasa (IUC)
Karabuk Training and Research Hospital
Information provided by (Responsible Party):
Seda Serhatlioglu, Karabuk University

Brief Summary:
In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing barrier and breast milk used in the first ten days of breastfeeding to prevent the formation of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women. Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no treatment-control).

Condition or disease Intervention/treatment Phase
Breastfeeding Cracked Nipple in Puerperium Device: Beeswax containing barrier Biological: Breast milk Not Applicable

Detailed Description:

Current evidence-based guidelines report that the incidence of nipple cracks ranges between 34-96%. Nipple cracks generally occur in the first week after the birth and may continue in the following periods of breastfeeding. Nipple crack is the second most common reason to stop breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies has been expressed as extremely painful and terrible. It is known that breast milk, olive oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks, will successfully allow to continue breastfeeding. In this way, breastfeeding will not be interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months. Using non-pharmacological, effective and therapeutic methods will also have a positive effect to increase the rate of breastfeeding.

Studies in the literature cover the evaluation of the effectiveness of beeswax or beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an effective and sufficient material in preventing and healing nipple cracks.

In this study, it is planned to include 90 lactating women (30 women in each group) to meet the parametric test assumptions in the experimental and control groups (beeswax-containing barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the experimental and control groups will be randomized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of the Use of Beeswax-containing Barrier on the Prevention of Nipple Crack in Lactating Primiparous Women Within the First 24 Hours After Giving the Birth: A Randomized Controlled Trial
Actual Study Start Date : February 17, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Beeswax containing barrier
Beeswax containing barrier will be given to the breastfeeding mother within the first 24 hours. After breastfeeding, it can be placed on the breast after it is expected to dry a little.Outside of breastfeeding and bathing, it will be constantly attached to the breasts.
Device: Beeswax containing barrier
Use beeswax containing barrier on each nipple after each breastfeeding.

Experimental: Breast milk
After breastfeeding, 2-3 drops of breast milk are applied to the nipple and areola. After the milk has dried, the breasts are closed. This application should be done at least 5 times a day.
Biological: Breast milk
Apply breast milk on each nipple and areola after each breastfeeding.

No Intervention: No treatment- control
It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done.

Primary Outcome Measures :
  1. Nipple crack change [ Time Frame: Change from baseline nipple crack at 10 days ]
    Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases)

Secondary Outcome Measures :
  1. Severity of nipple pain change [ Time Frame: Change from baseline severity of nipple pain at 10 days. ]
    Use Numeric Rating Scale 0-10 point (The severity of pain increases as the score increases)

Other Outcome Measures:
  1. Presence of nipple pain change [ Time Frame: Change from baseline presence of nipple pain at 10 days. ]
    Questionary (Yes/No)

  2. Maternal satisfaction [ Time Frame: Baseline from baseline nipple crack at 10 days ]
    Questionary (Use the satisfaction categories-likert)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   primipara lactating women who is in the first ten days of breastfeeding
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Being over 18 years old;
  • Normal spontaneous delivery.
  • Pregnancy weeks between 37-42.
  • Single birth.
  • Initiated breastfeeding.
  • Having given birth to a healthy, full-term child.
  • Newborn with no oral, palatal or maxillofacial abnormalities.
  • Not taking any medication, considering that drug use may cause nipple problems.
  • Being able to read and write.
  • Volunteering to participate in the study.
  • Not having contraindications for breastfeeding.

Exclusion Criteria:

  • Not approving to participate in the research.
  • Being a multipara.
  • Not breastfeeding within the first 24 hours.
  • Development of any breast problem: Mastitis, engorgement etc.
  • Taking newborn into intensive care.
  • Not sticking to the application.
  • Using another nipple crack preventing method during application.
  • Being allergic to beeswax.

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): NCT04259320

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Karabuk University Training and Research Hospital
Karabük, Merkez, Turkey, 07780
Sponsors and Collaborators
Karabuk University
Istanbul University - Cerrahpasa (IUC)
Karabuk Training and Research Hospital
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Study Director: Sibel Mutlu, OB/GYN Karabuk University Research and Training Hospital
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Responsible Party: Seda Serhatlioglu, Principal Investigator, Karabuk University
ClinicalTrials.gov Identifier: NCT04259320    
Other Study ID Numbers: E-01
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: After begin to study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Infective Agents