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Use of Bee Wax Mammary Areolae to Improve Breastfeeding

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ClinicalTrials.gov Identifier: NCT03676608
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
María Mercedes Rizo-Baeza, University of Alicante

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.


Condition or disease Intervention/treatment Phase
Breastfeeding Biological: Bee Wax Mammary Areolae Other: Usual educational care Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Health Education to Improve Adherence to Breastfeeding in Primiparous Women Through the Use of Bee Wax Mammary Areolae
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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.




Primary Outcome Measures :
  1. Percentage of women with exclusive breastfeeding for 6 months. [ Time Frame: 6 months ]
  2. Exclusive breastfeeding time in days. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mammary congestion [ Time Frame: 6 months ]
    This is measured by the clinical diagnosis.

  2. Mastitis [ Time Frame: 6 months ]
    This is measured by the clinical diagnosis.

  3. Cracks [ Time Frame: 6 months ]
    This is measured by the clinical diagnosis.

  4. Irritation [ Time Frame: 6 months ]
    This is measured by the clinical diagnosis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Primiparaous women.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676608


Contacts
Contact: María M Rizo-Baeza, PhD +34965903400 ext 3105 mercedes.rizo@ua.es

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

Publications:
Responsible Party: María Mercedes Rizo-Baeza, Professor, University of Alicante
ClinicalTrials.gov Identifier: NCT03676608     History of Changes
Other Study ID Numbers: UA-2014-11-12
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be publicly available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Propolis
Anti-Infective Agents