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Clinical Trials/NCT05191303
NCT05191303
Unknown
Not Applicable

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

University of Oulu1 site in 1 country228 target enrollmentApril 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Feeding, Exclusive
Sponsor
University of Oulu
Enrollment
228
Locations
1
Primary Endpoint
Exclusive breastfeeding relative rate at 4 months of age
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2022
End Date
September 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pirkko Nikula

Principal Investigator

University of Oulu

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Exclusive breastfeeding relative rate at 4 months of age

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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