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Nursing Education Intervention for Maternal Breastfeeding

Primary Purpose

Breast Feeding, Postpartum Breast Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preventive education
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Feeding focused on measuring Breastfeeding, Nursing, Patient Education as Topic, Health Knowledge, Attitudes, Practice, Hispanic Americans.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • primiparous women,
  • no contraindications to breastfeeding,
  • no skin disorders,
  • no breast surgery,
  • voluntary provision of data to enable their later localization.

Exclusion Criteria:

  • women who planned to deliver their babies in other hospitals,
  • twin pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Conventional

    Preventive education

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Breastfeeding duration
    Breastfeeding duration

    Secondary Outcome Measures

    Knowledge about breastfeeding and care of the breasts,
    Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis

    Full Information

    First Posted
    March 28, 2014
    Last Updated
    April 2, 2014
    Sponsor
    Universidad Miguel Hernandez de Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02106026
    Brief Title
    Nursing Education Intervention for Maternal Breastfeeding
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    October 2006 (Actual)
    Study Completion Date
    October 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Miguel Hernandez de Elche

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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'.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Feeding, Postpartum Breast Disorders
    Keywords
    Breastfeeding, Nursing, Patient Education as Topic, Health Knowledge, Attitudes, Practice, Hispanic Americans.

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    314 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Preventive education
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Preventive education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Breastfeeding duration
    Time Frame
    At 6 months postpartum
    Title
    Breastfeeding duration
    Time Frame
    At 1 month postpartum
    Secondary Outcome Measure Information:
    Title
    Knowledge about breastfeeding and care of the breasts,
    Time Frame
    Inmediate postpartum period.
    Title
    Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis
    Time Frame
    At 1 month postpartum

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primiparous women, no contraindications to breastfeeding, no skin disorders, no breast surgery, voluntary provision of data to enable their later localization. Exclusion Criteria: women who planned to deliver their babies in other hospitals, twin pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Concepcion Carratala-Munuera, PhD
    Organizational Affiliation
    Universidad Miguel Hernandez de Elche
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Nursing Education Intervention for Maternal Breastfeeding

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