BreastfeedingBSES-SFNCT04757324
Breast Milk and Breastfeeding Education Given in the Antenatal Period
A study testing breastfeeding education in people with Breastfeeding, run by Uludag University.
Trial summary
We aimed to examine the influence of breast milk and breastfeeding education given in the ante-natal period on LATCH score and breastfeeding self-efficacy score. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- breastfeeding education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
inclusion criteria Being above 18 years of age, Having completed the 26th gestational week (At training phase), Having no problem with vision and hearing, Having no disease that can prevent breastfeeding, Having a pregnancy with no risk, Having no systemic disease, Planning to breastfeed after birth
excusion criteria the mother stops researching. treating the baby in neonatal intensive care
About this study
Official title: The Influence of Breast Milk and Breastfeeding Education Given in the Antenatal Period on Breastfeeding Success and Breastfeeding Self-efficacy: Randomize Control Trials
We aimed to examine the influence of breast milk and breastfeeding education given in the ante-natal period on LATCH score and breastfeeding self-efficacy score.
Read the detailed description
Practices for increasing breastfeeding self-efficacy are of vital importance and they increase the level of breastfeeding self-efficacy. Breast milk and breastfeeding educations have given in the ante-natal period are another way of increasing the success of breastfeeding.
In this experimental investigation, 80 pregnant women who attended a baby-friendly hospital were randomly assigned to the education (n = 40) or control (n = 40) groups. The pregnant women in the intervention group received 4 hours of human milk and breastfeeding educational sessions along with routine care and furthermore, a brochure prepared by the researcher was given. All women whose estimated delivery date had approximated were questioned about whether they had given birth or not, and the sociodemographic data form, the LATCH Breastfeeding Assessment Tool and the Breastfeeding Self-efficacy Scale-short form were applied to the subjects in the education and the control group by visiting them at home when the post-partum first week had been completed.
- Conditions
- Breastfeeding
- Being tested
- breastfeeding education
- Keywords
- Breastfeeding success, Breastfeeding education, Breastfeeding self-efficacy perception, Breast milk, Antenatal period
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding educationOther
Also called antenatal education
| Study group | Role | What they receive |
|---|---|---|
| education arm | Experimental | Breastfeeding training was given to the training arm Receives: Other: breastfeeding education |
| control arm | No intervention | Breastfeeding training not given to control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in self-efficacy on the 70 points Breastfeeding Self-efficacy Scale-short form at week 1
Measured: baseline and week 1
Change from baseline in LATCH score on the 70 points LATCH Breastfeeding Assessment Toolform at week 1
breastfeeding success
Measured: baseline in week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Collaborators
- Balikesir University
- Responsible party
- Principal investigator, Rukiye Öztürk, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757324
- Sponsor's protocol ID
- Breastfeeding Education
- Acronym
- BSES-SF
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozturk R, Ergun S, Ozyazicioglu N. Effect of antenatal educational intervention on maternal breastfeeding self-efficacy and breastfeeding success: a quasi-experimental study. Rev Esc Enferm USP. 2022 Apr 4;56:e20210428. doi: 10.1590/1980-220X-REEUSP-2021-0428. eCollection 2022.
PubMed 35377385
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Breast Milk and Breastfeeding Education Given in the Antenatal Period on Breastfeeding Success and Breastfeeding Self-efficacy: Randomize Control Trials
- ClinicalTrials.gov ID
- NCT04757324
- Acronym / sponsor ID
- BSES-SF / Breastfeeding Education
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding success, Breastfeeding education, Breastfeeding self-efficacy perception, Breast milk, Antenatal period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- Balikesir University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 17 Feb 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.
We aimed to examine the influence of breast milk and breastfeeding education given in the ante-natal period on LATCH score and breastfeeding self-efficacy score.
Detailed description
Practices for increasing breastfeeding self-efficacy are of vital importance and they increase the level of breastfeeding self-efficacy. Breast milk and breastfeeding educations have given in the ante-natal period are another way of increasing the success of breastfeeding.
In this experimental investigation, 80 pregnant women who attended a baby-friendly hospital were randomly assigned to the education (n = 40) or control (n = 40) groups. The pregnant women in the intervention group received 4 hours of human milk and breastfeeding educational sessions along with routine care and furthermore, a brochure prepared by the researcher was given. All women whose estimated delivery date had approximated were questioned about whether they had given birth or not, and the sociodemographic data form, the LATCH Breastfeeding Assessment Tool and the Breastfeeding Self-efficacy Scale-short form were applied to the subjects in the education and the control group by visiting them at home when the post-partum first week had been completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education arm | Experimental | Other: breastfeeding educationBreastfeeding training was given to the training arm |
| control arm | No intervention | –Breastfeeding training not given to control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| breastfeeding educationAlso: antenatal education | Other | education arm |
Primary outcome
Change from baseline in self-efficacy on the 70 points Breastfeeding Self-efficacy Scale-short form at week 1
Time frame: baseline and week 1
Change from baseline in LATCH score on the 70 points LATCH Breastfeeding Assessment Toolform at week 1
Time frame: baseline in week 1
breastfeeding success
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 17 Feb 2021.
- Derived from this study: PubMed 35377385Ozturk R, Ergun S, Ozyazicioglu N. Effect of antenatal educational intervention on maternal breastfeeding self-efficacy and breastfeeding success: a quasi-experimental study. Rev Esc Enferm USP. 2022 Apr 4;56:e20210428. doi: 10.1590/1980-220X-REEUSP-2021-0428. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding education in people with Breastfeeding, run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in self-efficacy on the 70 points Breastfeeding Self-efficacy Scale-short form at week 1 (time frame: baseline and week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757324, which also lists 1 linked publication.
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 17 Feb 2021.