BreastfeedingNCT02994810
Orientation Effects of Breastfeeding for Mothers
A study testing Breastfeeding guidance in people with Breastfeeding, run by Hospital Moinhos de Vento at 1 site in Brazil.
Trial summary
The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Sep 2012
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mothers living in the city of Porto Alegre
Who cannot join
- Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orientation Effects of Breastfeeding for Mothers in a Private Hospital: Randomized Controlled Trial
The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO).
Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.
Read the detailed description
Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the first six months of a baby's life.
110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.
The first stage was carried out in the maternity - Orientation: Breastfeeding Importance Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the intervention group held three home visits:
10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for both groups.
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding guidance
- Keywords
- Breastfeeding, Orientation
- Medical subject headings
- Breast Feeding, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding guidanceOther
Breastfeeding guidance
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Guidelines and review of the breastfeeding techniques. Receives: Other: Breastfeeding guidance |
| Control group | No intervention | The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Breastfeeding for Mothers measured by structured questionnaire
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startMar 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salete Matos, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994810
- Sponsor's protocol ID
- HMV - Breastfeeding
- Status last verified
- Dec 2016
- First submitted
- 7 Jan 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orientation Effects of Breastfeeding for Mothers in a Private Hospital: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02994810
- Acronym / sponsor ID
- HMV - Breastfeeding
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Orientation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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.
The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO).
Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.
Detailed description
Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the first six months of a baby's life.
110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.
The first stage was carried out in the maternity - Orientation: Breastfeeding Importance Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the intervention group held three home visits:
10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Breastfeeding guidanceGuidelines and review of the breastfeeding techniques. |
| Control group | No intervention | –The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers living in the city of Porto Alegre
Key exclusion criteria (1 listed)
- Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized
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 guidanceBreastfeeding guidance | Other | Intervention group |
Primary outcome
Effects of Breastfeeding for Mothers measured by structured questionnaire
Time frame: Six months
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 16 Dec 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding guidance in people with Breastfeeding, run by Hospital Moinhos de Vento at 1 site in Brazil.
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 1 inclusion and 1 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 16 Dec 2016. 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 Brazil. 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?
Effects of Breastfeeding for Mothers measured by structured questionnaire (time frame: Six months). 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 16 Dec 2016.