Use of Bee Wax Mammary Areolae to Improve Breastfeeding

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676608
• Other study ID #: UA-2014-11-12
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2018
• Source: University of Alicante
• Contact: María M Rizo-Baeza, PhD
• Phone: +34965903400
• Email: mercedes.rizo[@]ua.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
Colombia	Universidad Simón Bolívar	Barranquilla
Mexico	Universidad Autónoma de Nuevo León	San Nicolás De Los Garza	Nuevo León
Spain	University of Alicante	San Vicente Del Raspeig	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Countries where clinical trial is conducted

Colombia,  Mexico,  Spain, 

References & Publications (2)

Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD001141. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women with exclusive breastfeeding for 6 months.		6 months
Primary	Exclusive breastfeeding time in days.		6 months
Secondary	Mammary congestion	This is measured by the clinical diagnosis.	6 months
Secondary	Mastitis	This is measured by the clinical diagnosis.	6 months
Secondary	Cracks	This is measured by the clinical diagnosis.	6 months
Secondary	Irritation	This is measured by the clinical diagnosis.	6 months