The Management of Perceived Breastmilk Insufficiency

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Milk Expression; Breast Feeding, Exclusive
• Intervention / Treatment: Behavioral: Structured education and follow-up

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Efeler
    • Aydın, Efeler, Turkey, 09100
      • Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study group were provided with education with structured educational material and followed in this study, in addition to the usual care provided by healthcare professionals.	Behavioral: Structured education and follow-up; This structured educational material was developed by the authors on the basis of the literature. Interventions of the study were carried out in the 32nd-42nd week of pregnancy, 3rd-7th day postpartum, and at the 1st month. At first stage, a 15-20-minute education was given to the pregnant women in the study group in the breastfeeding room of the facility, educational booklets were distributed. The main emphasis parts of the education were repeated with a standard summary information form at each follow-up.
No Intervention: Control group; Control group was int the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The starting breastfeeding in the first hour	assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they started breastfeeding within the first hour after birth.	Postpartum 3rd-7th day
Bottle-feeding	assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they feed her baby with bottle-feeding.	Postpartum 3rd-7th day
The baby's amount of milk intake	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.	Postpartum 3rd-7th day
The baby's amount of milk intake	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.	Postpartum the 1st month
The baby's amount of milk intake	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.	Postpartum 2nd month
Exclusively feeding with mother's milk	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.	Postpartum 3rd-7th day
Exclusively feeding with mother's milk	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.	Postpartum the 1st month
Exclusively feeding with mother's milk	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.	Postpartum 2nd month
Believing breast milk is adequate	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.	Postpartum 3rd-7th day
Believing breast milk is adequate	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.	Postpartum the 1st month
Believing breast milk is adequate	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.	Postpartum 2nd month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baby's height	used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.	Postpartum 3rd-7th day
Baby's height	used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.	Postpartum 1st month
Baby's height	used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.	Postpartum 2nd month
Believing the baby is adequately fed.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.	Postpartum 3rd-7th day
Believing the baby is adequately fed.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.	Postpartum 1st month
Believing the baby is adequately fed.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.	Postpartum 2nd month
Being satisfied with baby's weight gain.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.	Postpartum 3rd-7th day
Being satisfied with baby's weight gain.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.	Postpartum 1st month
Being satisfied with baby's weight gain.	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.	Postpartum 2nd month
Baby's weight	used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.	Postpartum 3rd-7th day
Baby's weight	used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.	Postpartum 1st month
Baby's weight	used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.	Postpartum 2nd month

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Study Chair: Zekiye Karaçam, Prof. Dr., Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: follow-up; breastfeeding; education; breastmilk
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No