The Management of Perceived Breastmilk Insufficiency

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Milk Expression, Breast Feeding, Exclusive

Intervention / Treatment
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* Behavioral: Structured education and follow-up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>Control group was int the usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breastmilk, breastfeeding, education, follow-up