The Management of Perceived Breastmilk Insufficiency

NCT ID: NCT04729166

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-06-01

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.

Conditions

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Breast Milk Expression Breast Feeding, Exclusive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Structured education and follow-up

Intervention Type BEHAVIORAL

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.

Control group

Control group was int the usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Zekiye Karaçam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekiye Karaçam, Prof. Dr.

Role: STUDY_CHAIR

Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Locations

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Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Aydin, Efeler, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id

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