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Use of Bee Wax Mammary Areolae to Improve Breastfeeding

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03676608
Enrollment
240
Registered
2018-09-18
Start date
2018-06-01
Completion date
2019-12-31
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

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.

Interventions

BIOLOGICALBee 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.

OTHERUsual educational care

The WHO protocol for maternal lactation.

Sponsors

University of Alicante
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Percentage of women with exclusive breastfeeding for 6 months.6 months
Exclusive breastfeeding time in days.6 months

Secondary

MeasureTime frameDescription
Mammary congestion6 monthsThis is measured by the clinical diagnosis.
Mastitis6 monthsThis is measured by the clinical diagnosis.
Cracks6 monthsThis is measured by the clinical diagnosis.
Irritation6 monthsThis is measured by the clinical diagnosis.

Countries

Colombia, Mexico, Spain

Contacts

Primary ContactMaría M Rizo-Baeza, PhD
mercedes.rizo@ua.es+34965903400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026