Use of Bee Wax Mammary Areolae to Improve Breastfeeding

University of Alicante

Status and phase

Unknown

Phase 3

Conditions

Breastfeeding

Treatments

Biological: Bee Wax Mammary Areolae

Other: Usual educational care

Study type

Interventional

Funder types

Other

Identifiers

NCT03676608

UA-2014-11-12

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 2 patient groups

Bee wax mammary areolae

Experimental group

Description:

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.

Treatment:

Biological: Bee Wax Mammary Areolae

Other: Usual educational care

Control

Active Comparator group

Description:

Usual educational care.

Treatment:

Other: Usual educational care