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临床试验/NCT03676608
NCT03676608Unknown3 期

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

University of Alicante4 个研究点 分布在 3 个国家目标入组 240 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
240
试验地点
4
主要终点
Percentage of women with exclusive breastfeeding for 6 months.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Bee Wax Mammary Areolae (Biological)

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.

干预措施: Usual educational care (Other)

Control

Active Comparator

Usual educational care.

干预措施: Usual educational care (Other)

结局指标

主要结局

Percentage of women with exclusive breastfeeding for 6 months.

时间窗: 6 months

Exclusive breastfeeding time in days.

时间窗: 6 months

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Mercedes Rizo-Baeza

Professor

University of Alicante

研究点 (4)

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