BreastfeedingNCT04259320
The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
A study testing Beeswax containing barrier and Breast milk in people with Breastfeeding and Cracked Nipple in Puerperium, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Cracked Nipple in Puerperium
- What is being tested?
- Beeswax containing barrier and Breast milk
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University Training and Research Hospital
Karabük, Merkez, 07780
About this study
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
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).
Read the 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.
- Conditions
- Breastfeeding, Cracked Nipple in Puerperium
- Being tested
- Beeswax containing barrier, Breast milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beeswax containing barrierDevice
Use beeswax containing barrier on each nipple after each breastfeeding.
Breast milkBiological
Apply breast milk on each nipple and areola after each breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Beeswax containing barrier | Experimental | 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. Receives: Device: Beeswax containing barrier |
| Breast milk | Experimental | 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. Receives: Biological: Breast milk |
| No treatment- control | No intervention | It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nipple crack change
Use Nipple Crack score 0-3 (Nipple cracks increase as the score increases)
Measured: Change from baseline nipple crack at 10 days
Secondary outcomes (1)
Severity of nipple pain change
Use Numeric Rating Scale 0-10 point (The severity of pain increases as the score increases)
Measured: Change from baseline severity of nipple pain at 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start17 Feb 2020
- Primary completion30 Jun 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Karabuk Training and Research Hospital
- Responsible party
- Principal investigator, Seda Serhatlioglu, Karabuk University
- Investigators
- Sibel Mutlu, OB/GYN, Study director, Karabuk University Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259320
- Sponsor's protocol ID
- E-01
- Status last verified
- Oct 2021
- First submitted
- 2 Feb 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After begin to study
Publications
Buck ML, Amir LH, Cullinane M, Donath SM; CASTLE Study Team. Nipple pain, damage, and vasospasm in the first 8 weeks postpartum. Breastfeed Med. 2014 Mar;9(2):56-62. doi: 10.1089/bfm.2013.0106. Epub 2013 Dec 31.
PubMed 24380583Puapornpong P, Paritakul P, Suksamarnwong M, Srisuwan S, Ketsuwan S. Nipple Pain Incidence, the Predisposing Factors, the Recovery Period After Care Management, and the Exclusive Breastfeeding Outcome. Breastfeed Med. 2017 Apr;12:169-173. doi: 10.1089/bfm.2016.0194. Epub 2017 Mar 9.
PubMed 28278382Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2.
PubMed 25506813Serhatlioglu S, Gencturk N, Mutlu S. Determination of the effectiveness of beeswax in preventing nipple pain and cracks in primiparous breastfeeding mothers: A randomized controlled trial. Explore (NY). 2023 Nov-Dec;19(6):851-858. doi: 10.1016/j.explore.2023.05.002. Epub 2023 May 13.
PubMed 37236877
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04259320
- Acronym / sponsor ID
- E-01
- Conditions
- Breastfeeding, Cracked Nipple in Puerperium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Karabuk Training and Research Hospital
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Beeswax containing barrier | Experimental | Device: Beeswax containing barrierBeeswax 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. |
| Breast milk | Experimental | Biological: Breast milkAfter 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. |
| No treatment- control | No intervention | –It is a group that does not use any method to prevent nipple cracks. All follow-ups in the experimental groups are done. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Being over 18 years old;
- Normal spontaneous delivery.
- Pregnancy weeks between 37-42.
- Single birth.
- Initiated breastfeeding.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beeswax containing barrierUse beeswax containing barrier on each nipple after each breastfeeding. | Device | Beeswax containing barrier |
| Breast milkApply breast milk on each nipple and areola after each breastfeeding. | Biological | Breast milk |
Primary outcome
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)
1 secondary outcome
Severity of nipple pain change
Time frame: Change from baseline severity of nipple pain at 10 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 24380583Buck ML, Amir LH, Cullinane M, Donath SM; CASTLE Study Team. Nipple pain, damage, and vasospasm in the first 8 weeks postpartum. Breastfeed Med. 2014 Mar;9(2):56-62. doi: 10.1089/bfm.2013.0106. Epub 2013 Dec 31.
- Background: PubMed 28278382Puapornpong P, Paritakul P, Suksamarnwong M, Srisuwan S, Ketsuwan S. Nipple Pain Incidence, the Predisposing Factors, the Recovery Period After Care Management, and the Exclusive Breastfeeding Outcome. Breastfeed Med. 2017 Apr;12:169-173. doi: 10.1089/bfm.2016.0194. Epub 2017 Mar 9.
- Background: PubMed 25506813Dennis CL, Jackson K, Watson J. Interventions for treating painful nipples among breastfeeding women. Cochrane Database Syst Rev. 2014 Dec 15;2014(12):CD007366. doi: 10.1002/14651858.CD007366.pub2.
- Derived from this study: PubMed 37236877Serhatlioglu S, Gencturk N, Mutlu S. Determination of the effectiveness of beeswax in preventing nipple pain and cracks in primiparous breastfeeding mothers: A randomized controlled trial. Explore (NY). 2023 Nov-Dec;19(6):851-858. doi: 10.1016/j.explore.2023.05.002. Epub 2023 May 13.
- Individual participant dataSharing planned: No. After begin to study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Mutlu, OB/GYN study director
Karabuk University Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beeswax containing barrier and Breast milk in people with Breastfeeding and Cracked Nipple in Puerperium, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nipple crack change (time frame: Change from baseline nipple crack at 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04259320, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.