Clinical trial NCT04729166: The Management of Perceived Breastmilk Insufficiency
Official title: Effectiveness of Structured Education and Follow-up on Management of Perceived Breastmilk Insufficiency: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Milk Expression
Breast Feeding, Exclusive
Keywords: breastmilk
breastfeeding
education
follow-up
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The starting breastfeeding in the first hour
timeFrame: Postpartum 3rd-7th day
measure: Bottle-feeding
timeFrame: Postpartum 3rd-7th day
measure: The baby's amount of milk intake
timeFrame: Postpartum 3rd-7th day
measure: The baby's amount of milk intake
timeFrame: Postpartum the 1st month
measure: The baby's amount of milk intake
timeFrame: Postpartum 2nd month
measure: Exclusively feeding with mother's milk
timeFrame: Postpartum 3rd-7th day
measure: Exclusively feeding with mother's milk
timeFrame: Postpartum the 1st month
measure: Exclusively feeding with mother's milk
timeFrame: Postpartum 2nd month
measure: Believing breast milk is adequate
timeFrame: Postpartum 3rd-7th day
measure: Believing breast milk is adequate
timeFrame: Postpartum the 1st month
measure: Believing breast milk is adequate
timeFrame: Postpartum 2nd month
Secondary outcomes:
measure: Baby's height
timeFrame: Postpartum 3rd-7th day
measure: Baby's height
timeFrame: Postpartum 1st month
measure: Baby's height
timeFrame: Postpartum 2nd month
measure: Believing the baby is adequately fed.
timeFrame: Postpartum 3rd-7th day
measure: Believing the baby is adequately fed.
timeFrame: Postpartum 1st month
measure: Believing the baby is adequately fed.
timeFrame: Postpartum 2nd month
measure: Being satisfied with baby's weight gain.
timeFrame: Postpartum 3rd-7th day
measure: Being satisfied with baby's weight gain.
timeFrame: Postpartum 1st month
measure: Being satisfied with baby's weight gain.
timeFrame: Postpartum 2nd month
measure: Baby's weight
timeFrame: Postpartum 3rd-7th day
measure: Baby's weight
timeFrame: Postpartum 1st month
measure: Baby's weight
timeFrame: Postpartum 2nd month
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
state: Efeler
Study officials:
affiliation: Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
name: Zekiye Karaçam, Prof. Dr.
role: STUDY_CHAIR
References: