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Clinical Trials/NCT03676608
NCT03676608
Unknown
Phase 3

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

University of Alicante3 sites in 3 countries240 target enrollmentJune 1, 2018
ConditionsBreastfeeding

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
University of Alicante
Enrollment
240
Locations
3
Primary Endpoint
Percentage of women with exclusive breastfeeding for 6 months.
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

María Mercedes Rizo-Baeza

Professor

University of Alicante

Eligibility 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.

Outcomes

Primary Outcomes

Percentage of women with exclusive breastfeeding for 6 months.

Time Frame: 6 months

Exclusive breastfeeding time in days.

Time Frame: 6 months

Secondary Outcomes

  • Irritation(6 months)
  • Mastitis(6 months)
  • Mammary congestion(6 months)
  • Cracks(6 months)

Study Sites (3)

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