Use of Bee Wax Mammary Areolae to Improve Breastfeeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

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.

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Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bee Wax Mammary Areolae

Intervention Type BIOLOGICAL

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 care

Intervention Type OTHER

The WHO protocol for maternal lactation.

Control

Usual educational care.

Group Type ACTIVE_COMPARATOR

Usual educational care

Intervention Type OTHER

The WHO protocol for maternal lactation.

Interventions

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Bee Wax Mammary Areolae

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.

Intervention Type BIOLOGICAL

Usual educational care

The WHO protocol for maternal lactation.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes