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Clinical Trials/NCT04729166
NCT04729166CompletedNot Applicable

Effectiveness of Structured Education and Follow-up on Management of Perceived Breastmilk Insufficiency: A Randomized Control Trial

Aydin Adnan Menderes University2 sites in 2 countries70 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Bottle-feeding

Study Overview

Brief Summary

A randomized control trial was made to determine the effectiveness of structured education and follow-up in the management of perceived milk insufficiency among breastfeeding mothers.

Detailed Description

Mothers 'perception of breastmilk insufficiency are important conditions affecting babies' exclusively breastfeeding in the first six months.

This study was made to determine the effectiveness of structured education and follow-up in the management of perceived breastmilk insufficiency among breastfeeding mothers. It was tested the hypotheses that there are no differences between mothers who have been provided with structured education and follow-up and those who have not received the education in terms of initiating breastfeeding in the first one hour, breastmilk insufficiency perceptions, the rate of exclusive feeding of breast milk to babies 0-2 months old, the baby's amount of milk intake and weight gain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Women in their 32nd-42nd week of pregnancy
  • Being literate in Turkish
  • Being at least a primary school graduate

Exclusion Criteria

  • Having a history of psychological or mental health problems
  • Having any condition in the mother or infant that was a barrier to breastfeeding
  • The baby's admission into the neonatal unit
  • The baby's separation from the mother for any reason

Outcomes

Primary Outcomes

Bottle-feeding

Time Frame: Postpartum 3rd-7th day

assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they feed her baby with bottle-feeding.

Exclusively feeding with mother's milk

Time Frame: Postpartum 2nd month

assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.

The starting breastfeeding in the first hour

Time Frame: Postpartum 3rd-7th day

assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they started breastfeeding within the first hour after birth.

Believing breast milk is adequate

Time Frame: Postpartum 2nd month

assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.

The baby's amount of milk intake

Time Frame: Postpartum 2nd month

assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake.

Secondary Outcomes

  • Baby's height(Postpartum 2nd month)
  • Being satisfied with baby's weight gain.(Postpartum 2nd month)
  • Baby's weight(Postpartum 2nd month)
  • Believing the baby is adequately fed.(Postpartum 2nd month)

Investigators

Sponsor
Aydin Adnan Menderes University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zekiye Karaçam

Professor

Aydin Adnan Menderes University

Study Sites (2)

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