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

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.

Study Overview

• Status: Unknown
• Conditions: Breastfeeding
• Intervention / Treatment: Biological: Bee Wax Mammary Areolae; Other: Usual educational care

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: María M Rizo-Baeza, PhD; Phone Number: 3105 +34965903400; Email: mercedes.rizo@ua.es

Study Locations

• Colombia
  • Barranquilla, Colombia
    • Recruiting
    • Universidad Simón Bolívar
    • Contact: Isaac Kuzmar, MD, PhD
• Mexico
  • Nuevo León
    • San Nicolás De Los Garza, Nuevo León, Mexico
      • Recruiting
      • Universidad Autonoma de Nuevo Leon
      • Contact: Velia M Cárdenas-Villarreal, PhD
• Spain
  • Alicante
    • San Vicente Del Raspeig, Alicante, Spain, 03600
      • Recruiting
      • University of Alicante
      • Contact: María M Rizo-Baeza, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.; Other: Usual educational care; The WHO protocol for maternal lactation.
Active Comparator: Control; Usual educational care.	Other: Usual educational care; The WHO protocol for maternal lactation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Alicante

Publications and helpful links

General Publications

• Vieira F, Bachion MM, Mota DD, Munari DB. A systematic review of the interventions for nipple trauma in breastfeeding mothers. J Nurs Scholarsh. 2013 Jun;45(2):116-25. doi: 10.1111/jnu.12010. Epub 2013 Mar 1.
• Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UA-2014-11-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will not be publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No