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Nursing Education Intervention for Maternal Breastfeeding

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ClinicalTrials.gov Identifier: NCT02106026
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Concepcion Carratala-Munuera, Universidad Miguel Hernandez de Elche

Brief Summary:
An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications.

Condition or disease Intervention/treatment Phase
Breast Feeding Postpartum Breast Disorders Other: Preventive education Not Applicable

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'.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Conventional
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.
Experimental: Preventive education
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.
Other: Preventive education
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 Measures :
  1. Breastfeeding duration [ Time Frame: At 6 months postpartum ]
  2. Breastfeeding duration [ Time Frame: At 1 month postpartum ]

Secondary Outcome Measures :
  1. Knowledge about breastfeeding and care of the breasts, [ Time Frame: Inmediate postpartum period. ]
  2. Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis [ Time Frame: At 1 month postpartum ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106026


Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Investigators
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Principal Investigator: Concepcion Carratala-Munuera, PhD Universidad Miguel Hernandez de Elche

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Responsible Party: Concepcion Carratala-Munuera, Dr, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT02106026    
Other Study ID Numbers: LACT-120413
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by Concepcion Carratala-Munuera, Universidad Miguel Hernandez de Elche:
Breastfeeding
Nursing
Patient Education as Topic
Health Knowledge, Attitudes, Practice
Hispanic Americans.
Additional relevant MeSH terms:
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Breast Diseases
Skin Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs