BreastfeedingPhase 3NCT03676608
Use of Bee Wax Mammary Areolae to Improve Breastfeeding
A Phase 3 study testing Bee Wax Mammary Areolae and Usual educational care in people with Breastfeeding, run by University of Alicante at 3 sites in 3 countries.
Trial summary
A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Bee Wax Mammary Areolae and Usual educational care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primiparous women regardless of age.
- Attended in the consultation of midwives of health centers selected for the study.
- Signature of informed consent.
Who cannot join
- Atopias and dermatological problems.
- No willingness to continue breastfeeding.
- Mental diseases.
- Allergy to the products of the bee.
- No informed consent.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Colombia1 site, 1 recruiting
- Recruiting
Universidad Simón Bolívar
Barranquilla
Isaac Kuzmar, MD, PhD
Mexico1 site, 1 recruiting
- Recruiting
Universidad Autónoma de Nuevo León
San Nicolás de los Garza, Nuevo León
Velia M Cárdenas-Villarreal, PhD
Spain1 site, 1 recruiting
- Recruiting
University of Alicante
San Vicent del Raspeig, Alicante, 03600
María M Rizo-Baeza, PhD
About this study
Official title: Study of Health Education to Improve Adherence to Breastfeeding in Primiparous Women Through the Use of Bee Wax Mammary Areolae
A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. The use of both interventions can contribute to the adherence to exclusive maternity in 20% in the first 6 months of life, than only with the educational program.
The study provides evidence of nursing practice, thus contributing to the improvement of nursing mothers in the prevention of lesions in the nipple and care in them if they occur. Consequently, improve the rates of successful breastfeeding, as well as the quality of life of breastfeeding mothers. The study will be carried out with several groups of midwives in Health Centers, in Spain, Colombia and Mexico. The sample was calculated in 240 women who attend the midwife's controls between week 29 and 40.
- Conditions
- Breastfeeding
- Being tested
- Bee Wax Mammary Areolae, Usual educational care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Wax Mammary AreolaeBiological
The product to be valued are mammary areolae made by hand with organic beeswax. Despite its honey aroma, it does not contain honey. The wax used for the manufacture of the areolae is operculum. This wax is used and not another because it avoids possible residues and allergies that may contain other types of waxes. The operculum wax is used as a thickener in pharmacy and cosmetic products as a fat base in ointments and creams.
Usual educational careOther
The WHO protocol for maternal lactation.
| Study group | Role | What they receive |
|---|---|---|
| Bee wax mammary areolae | Experimental | Usual educational care plus the product.
The product to be valued are mammary areolae made by hand with organic beeswax. Despite its honey aroma, it does not contain honey. The wax used for the manufacture of the areolae is operculum. This wax is used and not another because it avoids possible residues and allergies that may contain other types of waxes. The operculum wax is used as a thickener in pharmacy and cosmetic products as a fat base in ointments and creams. Receives: Biological: Bee Wax Mammary Areolae; Other: Usual educational care |
| Control | Active comparator | Usual educational care. Receives: Other: Usual educational care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women with exclusive breastfeeding for 6 months.
Measured: 6 months
Exclusive breastfeeding time in days.
Measured: 6 months
Secondary outcomes (4)
Mammary congestion
This is measured by the clinical diagnosis.
Measured: 6 months
Mastitis
This is measured by the clinical diagnosis.
Measured: 6 months
Cracks
This is measured by the clinical diagnosis.
Measured: 6 months
Irritation
This is measured by the clinical diagnosis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Mercedes Rizo-Baeza, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676608
- Sponsor's protocol ID
- UA-2014-11-12
- Status last verified
- Sep 2018
- First submitted
- 29 Jun 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be publicly available.
Publications
Vieira F, Bachion MM, Mota DD, Munari DB. A systematic review of the interventions for nipple trauma in breastfeeding mothers. J Nurs Scholarsh. 2013 Jun;45(2):116-25. doi: 10.1111/jnu.12010. Epub 2013 Mar 1.
PubMed 23452043Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.
PubMed 17253455
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Health Education to Improve Adherence to Breastfeeding in Primiparous Women Through the Use of Bee Wax Mammary Areolae
- ClinicalTrials.gov ID
- NCT03676608
- Acronym / sponsor ID
- UA-2014-11-12
- Conditions
- Breastfeeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Sep 2018 (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.
A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. The use of both interventions can contribute to the adherence to exclusive maternity in 20% in the first 6 months of life, than only with the educational program.
The study provides evidence of nursing practice, thus contributing to the improvement of nursing mothers in the prevention of lesions in the nipple and care in them if they occur. Consequently, improve the rates of successful breastfeeding, as well as the quality of life of breastfeeding mothers. The study will be carried out with several groups of midwives in Health Centers, in Spain, Colombia and Mexico. The sample was calculated in 240 women who attend the midwife's controls between week 29 and 40.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bee wax mammary areolae | Experimental | Biological: Bee Wax Mammary Areolae, Other: Usual educational careUsual educational care plus the product. The product to be valued are mammary areolae made by hand with organic beeswax. Despite its honey aroma, it does not contain honey. The wax used for the manufacture of the areolae is operculum. This wax is used and not another because it avoids possible residues and allergies that may contain other types of waxes. The operculum wax is used as a thickener in pharmacy and cosmetic products as a fat base in ointments and creams. |
| Control | Active comparator | Other: Usual educational careUsual educational care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primiparous women regardless of age.
- Attended in the consultation of midwives of health centers selected for the study.
- Signature of informed consent.
Key exclusion criteria (5 listed)
- Atopias and dermatological problems.
- No willingness to continue breastfeeding.
- Mental diseases.
- Allergy to the products of the bee.
- No informed consent.
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 |
|---|---|---|
| Bee Wax Mammary AreolaeThe product to be valued are mammary areolae made by hand with organic beeswax. Despite its honey aroma, it does not contain honey. The wax used for the manufacture of the areolae is operculum. This wax is used and not another because it avoids possible residues and allergies that may contain other types of waxes. The operculum wax is used as a thickener in pharmacy and cosmetic products as a fat base in ointments and creams. | Biological | Bee wax mammary areolae |
| Usual educational careThe WHO protocol for maternal lactation. | Other | Bee wax mammary areolae, Control |
Primary outcome
Percentage of women with exclusive breastfeeding for 6 months.
Time frame: 6 months
Exclusive breastfeeding time in days.
Time frame: 6 months
4 secondary outcomes
Mammary congestion
Time frame: 6 months
Mastitis
Time frame: 6 months
Cracks
Time frame: 6 months
Irritation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Background: PubMed 23452043Vieira F, Bachion MM, Mota DD, Munari DB. A systematic review of the interventions for nipple trauma in breastfeeding mothers. J Nurs Scholarsh. 2013 Jun;45(2):116-25. doi: 10.1111/jnu.12010. Epub 2013 Mar 1.
- Background: PubMed 17253455Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.
- Individual participant dataSharing planned: No. The data will not be publicly available.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bee Wax Mammary Areolae and Usual educational care in people with Breastfeeding, run by University of Alicante at 3 sites in 3 countries.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia, Mexico, Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María M Rizo-Baeza, PhD (+34965903400 ext. 3105, mercedes.rizo@ua.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women with exclusive breastfeeding for 6 months. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03676608, which also lists 2 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 18 Sep 2018.