Breast FeedingNCT02106026
Nursing Education Intervention for Maternal Breastfeeding
A study testing Preventive education in people with Breast Feeding and Postpartum Breast Disorders, run by Universidad Miguel Hernandez de Elche.
Trial summary
An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Feeding, Postpartum Breast Disorders
- What is being tested?
- Preventive education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Oct 2006
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primiparous women,
- no contraindications to breastfeeding,
- no skin disorders,
- no breast surgery,
- voluntary provision of data to enable their later localization.
Who cannot join
- women who planned to deliver their babies in other hospitals,
- twin pregnancy
About this study
Official title: Effectiveness of a Nursing Education Intervention on Duration of Breastfeeding and on Post-natal Breast Complications in Primiparous Women: a Randomized Controlled Trial
An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications.
Read the detailed description
A randomized controlled clinical trial of an educational intervention was undertaken at a public hospital. the investigators compared a health education based on techniques to prevent complications and increase information about the benefits of breastfeeding with the usual practice. A group of nurses delivered the educational intervention. The trial involved randomization of 314 primiparous women. The analysis was by 'intention-to-treat'.
- Conditions
- Breast Feeding, Postpartum Breast Disorders
- Being tested
- Preventive education
- Keywords
- Breastfeeding, Nursing, Patient Education as Topic, Health Knowledge, Attitudes, Practice, Hispanic Americans.
- Medical subject headings
- Breast Feeding, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive educationOther
The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | All expectant mothers received the usual information about the advantages of maternal milk during pre-natal period. Nurses provided the information in personalized dialogue with the women during obstetric consultations. |
| Preventive education | Experimental | It was provided by the nurses during obstetric consultation in pre-natal period and averaged 30 minutes in duration. The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures. The nurses encouraged participation and gave the education in personalized dialogue with the woman. The information was reinforced with an illustrated explanatory leaflet. Receives: Other: Preventive education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding duration
Measured: At 6 months postpartum
Breastfeeding duration
Measured: At 1 month postpartum
Secondary outcomes (2)
Knowledge about breastfeeding and care of the breasts,
Measured: Inmediate postpartum period.
Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis
Measured: At 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startDec 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Concepcion Carratala-Munuera, Universidad Miguel Hernandez de Elche
- Investigators
- Concepcion Carratala-Munuera, PhD, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106026
- Sponsor's protocol ID
- LACT-120413
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nursing Education Intervention on Duration of Breastfeeding and on Post-natal Breast Complications in Primiparous Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02106026
- Acronym / sponsor ID
- LACT-120413
- Conditions
- Breast Feeding, Postpartum Breast Disorders
- Keywords
- Breastfeeding, Nursing, Patient Education as Topic, Health Knowledge, Attitudes, Practice, Hispanic Americans.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 7 Apr 2014 (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.
An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications.
Detailed description
A randomized controlled clinical trial of an educational intervention was undertaken at a public hospital. the investigators compared a health education based on techniques to prevent complications and increase information about the benefits of breastfeeding with the usual practice. A group of nurses delivered the educational intervention. The trial involved randomization of 314 primiparous women. The analysis was by 'intention-to-treat'.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –All expectant mothers received the usual information about the advantages of maternal milk during pre-natal period. Nurses provided the information in personalized dialogue with the women during obstetric consultations. |
| Preventive education | Experimental | Other: Preventive educationIt was provided by the nurses during obstetric consultation in pre-natal period and averaged 30 minutes in duration. The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures. The nurses encouraged participation and gave the education in personalized dialogue with the woman. The information was reinforced with an illustrated explanatory leaflet. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- primiparous women,
- no contraindications to breastfeeding,
- no skin disorders,
- no breast surgery,
- voluntary provision of data to enable their later localization.
Key exclusion criteria (2 listed)
- women who planned to deliver their babies in other hospitals,
- twin pregnancy
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 |
|---|---|---|
| Preventive educationThe intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures. | Other | Preventive education |
Primary outcome
Breastfeeding duration
Time frame: At 6 months postpartum
Breastfeeding duration
Time frame: At 1 month postpartum
2 secondary outcomes
Knowledge about breastfeeding and care of the breasts,
Time frame: Inmediate postpartum period.
Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis
Time frame: At 1 month postpartum
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 7 Apr 2014.
Related trials for Breast Feeding
RecruitingObservational study
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
Fabry Disease
Enrolling by invitation
The Effect of Breastfeeding Education Delivered Via a Hybrid Model on Breastfeeding Efficacy and Postpartum Comfort Levels
Breastfeeding, Postpartum Comfort
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Not yet recruiting
THE EFFECT OF A VIRTUAL REALITY BREASTFEEDING EXPERIENCE ON BREASTFEEDING EXPECTATIONS AND AVOIDANCE
Breastfeeding Expectations, Breastfeeding Avoidance
Recruiting
Effect of Solution-Focused Approach Education on Breastfeeding Avoidance and Breastfeeding Self-Efficacy in Primiparous Mothers
Breastfeeding Avoidance and Breastfeeding Self-efficacy
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.
Concepcion Carratala-Munuera, PhD principal investigator
Universidad Miguel Hernandez de Elche
Questions about this trial
What is this clinical trial studying?
A study testing Preventive education in people with Breast Feeding and Postpartum Breast Disorders, run by Universidad Miguel Hernandez de Elche.
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 5 inclusion and 2 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 7 Apr 2014. 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?
Breastfeeding duration (time frame: At 6 months postpartum). 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?
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 7 Apr 2014.