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临床试验/NCT05191303
NCT05191303Unknown不适用

Developing Mobile Intervention of the Breast Feeding Counseling and Evaluating Its Effectiveness in Primiparous Mothers

University of Oulu2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
228
试验地点
2
主要终点
Exclusive breastfeeding relative rate at 4 months of age

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of mobile intervention for breastfeeding counseling (MIBFc) to improve exclusive breastfeeding duration among primiparous women in Finland.

详细描述

The investigators hypothesize that the use of mobile intervention for breastfeeding counseling to primiparous women improve the exclusive breastfeeding rates, breastfeeding attitudes, breastfeeding confidence and the satisfaction of breastfeeding counselling. These outcomes are assumed to be higher in the intervention group than in the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. Maternity care staff asks informed consent and then performs the randomization of primiparous women to the intervention or control group.

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
  • 18 years or older
  • finnish language
  • singleton foetus
  • have an intention to breastfeed
  • have a smartphone

排除标准

  • multiple pregnancy
  • risk pregnancy, or other disease to be monitored

结局指标

主要结局

Exclusive breastfeeding relative rate at 4 months of age

时间窗: 4 moths after childbirth

Proportion of infants exclusive breastfeeding at 4 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.

Exclusive breastfeeding relative rate at 1 months of age

时间窗: 1 month after childbirth

Proportion of infants exclusive breastfeeding at 1 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.

Exclusive breastfeeding relative rate at 6 months of age

时间窗: 6 months after childbirth

Proportion of infants exclusive breastfeeding at 6 month: Exclusive breastfeeding is defined when the infant only receives breast milk, D-vitamin and needed medicines.

次要结局

  • Breastfeeding Self-Efficacy Scale- Short Form (BSES-SF)(Measurements are made in 1 and 4 months after childbirth)
  • Satisfaction of breastfeeding guidance(Measurements are made in 18 and 34 weeks of gestation, and in 1 and 4 months after childbirth.)
  • Infants exclusive breastfeeding rate (relative share / portion)(The researcher retrieves the data from the patient record after 6 months of childbirth.)
  • The Iowa Infant Feeding Attitude Scale (IIFAS) at pregnancy(Measurements are made in 18 and 34 weeks of gestation)
  • Use of infants additional milk at hospital after childbirth(The researcher retrieves the data from the patient record after 6 months of childbirth.)

研究者

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

Pirkko Nikula

Principal Investigator

University of Oulu

研究点 (2)

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