Nursing Education Intervention for Maternal Breastfeeding

Breast Feeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106026
• Other study ID #: LACT-120413
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: April 2, 2014
• Start date: December 2004
• Est. completion date: October 2006

Study information

• Verified date: April 2014
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Diseases
• Breast Feeding
• Postpartum Breast Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding duration		At 6 months postpartum	No
Primary	Breastfeeding duration		At 1 month postpartum
Secondary	Knowledge about breastfeeding and care of the breasts,		Inmediate postpartum period.	No
Secondary	Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis		At 1 month postpartum	No