The Management of Perceived Breastmilk Insufficiency

January 26, 2021 updated by: Zekiye Karaçam, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Efeler
      • Aydın, Efeler, Turkey, 09100
        • Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
No Intervention: Control group
Control group was int the usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The starting breastfeeding in the first hour
Time Frame: 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.
Postpartum 3rd-7th day
Bottle-feeding
Time Frame: 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.
Postpartum 3rd-7th day
The baby's amount of milk intake
Time Frame: Postpartum 3rd-7th day
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
Time Frame: Postpartum the 1st 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.
Postpartum the 1st month
The baby's amount of milk intake
Time Frame: 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.
Postpartum 2nd month
Exclusively feeding with mother's milk
Time Frame: Postpartum 3rd-7th day
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
Time Frame: Postpartum the 1st month
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
Time Frame: Postpartum 2nd month
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
Time Frame: Postpartum 3rd-7th day
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
Time Frame: Postpartum the 1st month
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
Time Frame: Postpartum 2nd month
assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.
Postpartum 2nd month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baby's height
Time Frame: Postpartum 3rd-7th day
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
Time Frame: Postpartum 1st 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.
Postpartum 1st month
Baby's height
Time Frame: 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.
Postpartum 2nd month
Believing the baby is adequately fed.
Time Frame: Postpartum 3rd-7th day
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.
Time Frame: Postpartum 1st month
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.
Time Frame: Postpartum 2nd month
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.
Time Frame: Postpartum 3rd-7th day
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.
Time Frame: Postpartum 1st month
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.
Time Frame: Postpartum 2nd month
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
Time Frame: Postpartum 3rd-7th day
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
Time Frame: Postpartum 1st 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.
Postpartum 1st month
Baby's weight
Time Frame: 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.
Postpartum 2nd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zekiye Karaçam, Prof. Dr., Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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