Use of Bee Wax Mammary Areolae to Improve Breastfeeding

Study Overview
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Brief Summary
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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.

Official Title
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Study of Health Education to Improve Adherence to Breastfeeding in Primiparous Women Through the Use of Bee Wax Mammary Areolae

Conditions
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Breastfeeding

Intervention / Treatment
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* Biological: Bee Wax Mammary Areolae
* Other: Usual educational care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primiparous women regardless of age. Attended in the consultation of midwives of health centers selected for the study. Signature of informed consent. Exclusion Criteria: Atopias and dermatological problems. No willingness to continue breastfeeding. Mental diseases. Allergy to the products of the bee. No informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bee wax mammary areolae<br>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. | Biological: Bee Wax Mammary Areolae<br>* 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.<br>Other: Usual educational care<br>* The WHO protocol for maternal lactation.<br>|
| Active Comparator: Control<br>Usual educational care. | Other: Usual educational care<br>* The WHO protocol for maternal lactation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women with exclusive breastfeeding for 6 months. |  | 6 months | 
| Exclusive breastfeeding time in days. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mammary congestion | This is measured by the clinical diagnosis. | 6 months | 
| Mastitis | This is measured by the clinical diagnosis. | 6 months | 
| Cracks | This is measured by the clinical diagnosis. | 6 months | 
| Irritation | This is measured by the clinical diagnosis. | 6 months |