Use of Bee Wax Mammary Areolae to Improve Breastfeeding

NCT03676608 | Unknown Phase 3

• 1 other identifier: UA-2014-11-12
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 3

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Percentage of women with exclusive breastfeeding for 6 months.

  6 months

• Exclusive breastfeeding time in days.

  6 months

Secondary Outcomes (4)

• Mammary congestion

  6 months

• Mastitis

  6 months

• Cracks

  6 months

• Irritation

  6 months

Study Arms (2)

Bee wax mammary areolae

EXPERIMENTAL

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; Other: Usual educational care

Control

ACTIVE COMPARATOR

Usual educational care.

Other: Usual educational care

Interventions

Bee Wax Mammary Areolae 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.

Bee wax mammary areolae

Usual educational care OTHER

The WHO protocol for maternal lactation.

Bee wax mammary areolae; Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Primiparaous women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous women regardless of age.
• Attended in the consultation of midwives of health centers selected for the study.
• Signature of informed consent.

You may not qualify if:

• Atopias and dermatological problems.
• No willingness to continue breastfeeding.
• Mental diseases.
• Allergy to the products of the bee.
• No informed consent.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (3)

Universidad Simón Bolívar

Barranquilla, Colombia

RECRUITING

Universidad Autónoma de Nuevo León

San Nicolás de los Garza, Nuevo León, Mexico

RECRUITING

University of Alicante

San Vicent del Raspeig, Alicante, 03600, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 23452043 BACKGROUND

• 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.

  PMID: 17253455 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

María M Rizo-Baeza, PhD

CONTACT

+34965903400; mercedes.rizo@ua.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: September 18, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); ES (1); CO (1)