The Management of Perceived Breastmilk Insufficiency

Breast Feeding, Exclusive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04729166
• Other study ID #: Interventional
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2021
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Breast Milk Expression

Intervention

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.

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery	Aydin	Efeler

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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