Breast Milk ExpressionNCT04729166
The Management of Perceived Breastmilk Insufficiency
A study testing Structured education and follow-up in people with Breast Milk Expression and Breast Feeding, Exclusive, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Expression, Breast Feeding, Exclusive
- What is being tested?
- Structured education and follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women in their 32nd-42nd week of pregnancy
- Being literate in Turkish
- Being at least a primary school graduate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
Aydin, Efeler, 09100
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Milk Expression, Breast Feeding, Exclusive
- Being tested
- Structured education and follow-up
- Keywords
- breastmilk, breastfeeding, education, follow-up
- Medical subject headings
- Breast Milk Expression, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured education and follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Behavioral: Structured education and follow-up |
| Control group | No intervention | Control group was int the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postpartum 2nd month
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postpartum 2nd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Dec 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk ExpressionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye Karaçam, Aydin Adnan Menderes University
- Investigators
- Zekiye Karaçam, Prof. Dr., Study chair, Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729166
- Sponsor's protocol ID
- Interventional
- Status last verified
- Jan 2021
- First submitted
- 16 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Structured Education and Follow-up on Management of Perceived Breastmilk Insufficiency: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04729166
- Acronym / sponsor ID
- Interventional
- Conditions
- Breast Milk Expression, Breast Feeding, Exclusive
- Keywords
- breastmilk, breastfeeding, education, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Structured education and follow-upThe 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. |
| Control group | No intervention | –Control group was int the usual care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women in their 32nd-42nd week of pregnancy
- Being literate in Turkish
- Being at least a primary school graduate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured education and follow-upThis 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. | Behavioural | Study group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Baby's height
Time frame: Postpartum 3rd-7th day
Baby's height
Time frame: Postpartum 1st month
Baby's height
Time frame: Postpartum 2nd month
Believing the baby is adequately fed.
Time frame: Postpartum 3rd-7th day
Believing the baby is adequately fed.
Time frame: Postpartum 1st month
Believing the baby is adequately fed.
Time frame: Postpartum 2nd month
Being satisfied with baby's weight gain.
Time frame: Postpartum 3rd-7th day
Being satisfied with baby's weight gain.
Time frame: Postpartum 1st month
Being satisfied with baby's weight gain.
Time frame: Postpartum 2nd month
Baby's weight
Time frame: Postpartum 3rd-7th day
Baby's weight
Time frame: Postpartum 1st month
Baby's weight
Time frame: Postpartum 2nd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye Karaçam, Prof. Dr. study chair
Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education and follow-up in people with Breast Milk Expression and Breast Feeding, Exclusive, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The starting breastfeeding in the first hour (time frame: Postpartum 3rd-7th day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.