Nursing Education Intervention for Maternal Breastfeeding

April 2, 2014 updated by: Concepcion Carratala-Munuera, Universidad Miguel Hernandez de Elche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

314

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding duration
Time Frame: At 6 months postpartum
At 6 months postpartum
Breastfeeding duration
Time Frame: At 1 month postpartum
At 1 month postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Investigators

  • Principal Investigator: Concepcion Carratala-Munuera, PhD, Universidad Miguel Hernandez de Elche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACT-120413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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