Use of Bee Wax Mammary Areolae to Improve Breastfeeding

Phase 3

• Conditions: Breastfeeding
• Interventions: Biological: Bee Wax Mammary Areolae; Other: Usual educational care

• Registration Number: NCT03676608
• Lead Sponsor: University of Alicante

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-29
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-17
• Last Update Submitted: 2018-09-17
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bee wax mammary areolae	Bee Wax Mammary Areolae	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.
Control	Usual educational care	Usual educational care.
Bee wax mammary areolae	Usual educational care	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.

Primary Outcome Measures

Name	Time	Method
Percentage of women with exclusive breastfeeding for 6 months.	6 months
Exclusive breastfeeding time in days.	6 months

Secondary Outcome Measures

Name	Time	Method
Irritation	6 months	This is measured by the clinical diagnosis.
Mastitis	6 months	This is measured by the clinical diagnosis.
Mammary congestion	6 months	This is measured by the clinical diagnosis.
Cracks	6 months	This is measured by the clinical diagnosis.

Trial Locations

Locations (3)

University of Alicante; 🇪🇸 San Vicente Del Raspeig, Alicante, Spain

Universidad Simón Bolívar; 🇨🇴 Barranquilla, Colombia

Universidad Autónoma de Nuevo León; 🇲🇽 San Nicolás De Los Garza, Nuevo León, Mexico