The Management of Perceived Breastmilk Insufficiency

Not Applicable

Completed

• Conditions: Breast Feeding, Exclusive; Breast Milk Expression
• Interventions: Behavioral: Structured education and follow-up

• Registration Number: NCT04729166
• Lead Sponsor: Aydin Adnan Menderes University

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 Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-16
• Study First Submitted QC: 2021-01-26
• Last Update Submitted: 2021-01-26
• Study First Posted: 2021-01-28
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Structured education and follow-up	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.

Primary Outcome Measures

Name	Time	Method
Bottle-feeding	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	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	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	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	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 Outcome Measures

Name	Time	Method
Baby's height	Postpartum 2nd month	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.
Being satisfied with baby's weight gain.	Postpartum 2nd month	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.
Baby's weight	Postpartum 2nd month	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.
Believing the baby is adequately fed.	Postpartum 2nd month	assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby fed adequate.

Trial Locations

Locations (1)

Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery; 🇹🇷 Aydın, Efeler, Turkey