Evaluation of Breastfeeding Support After Short Time Hospitalization

February 10, 2017 updated by: Ingrid Nilsson, Danish Committee for Health Education

Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum

The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3541

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Sygehus
      • Hjoerring, Denmark, 9800
        • Sygehus Vendsyssel
      • Horsens, Denmark, 8700
        • Horsens Sygehus
      • Kolding, Denmark, 6000
        • Kolding Sygehus
      • Nykøbing F, Denmark, 4800
        • Nykøbing F Sygehuse
      • Randers, Denmark, 8900
        • Regionshospitalet Randers
      • Sønderborg, Denmark, 6400
        • Haderslev/Sønderborg sygehus
      • Thisted, Denmark, 7700
        • Sygehus Thy-Mors
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg

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:

  • pregnant women (gestational week 35-36)

Exclusion Criteria:

  • women with known physical, psychological and/or social illness/problem that result in hospitalization more than 50 hours after delivery
  • women with known pregnancy related illness that result in hospitalization more than 50 hours after delivery
  • Women not understanding or speaking Danish
  • women expecting multiple babies
  • women having decided not to breastfeed
  • women expecting to deliver at another hospital than the one she has been visiting during 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New breastfeeding programme

The breastfeeding programme consists of four core elements:

  1. breastfeeding is a parental task
  2. skin to skin contact during the first three days
  3. frequent breastfeeding at least 8 times a day
  4. good positioning, preferable in a laid back position

Moreover communication was supposed to enhance breastfeeding self-efficacy, using Banduras theory of self-efficacy
Other: New Breastfeeding Counselling
An intervention will be developed during the first part of the study. The intervention is supposed to consist of evidence based actions to support the metabolic adaptation of the newborn, establishment of the milk production of the mother and increase the breastfeeding self efficacy of the mother.
Active Comparator: Treatment as usual
Breastfeeding counselling uses the national handbook of breastfeeding as reference
Other: Treatment as usual
Health professionals offer the usual care for the breastfeeding mother

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parents breastfeeding self efficacy
Time Frame: 7 days post partum
7 days post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective breastfeeding
Time Frame: 7 days post partum
Effective breastfeeding is measured by the outcome measures: breastfeeding frequency, milk coming in before 3rd day pp, number of stools 3 days pp, baby's swallowing of milk
7 days post partum
Duration of exclusive and full breastfeeding
Time Frame: 7 and 30 days post partum and 6 month post partum
7 and 30 days post partum and 6 month post partum
Baby's morbidity
Time Frame: 7 and 30 days post partum and 6 month post partum
Measuring jaundice, dehydration, use of health facilities
7 and 30 days post partum and 6 month post partum
Breastfeeding problems
Time Frame: 7 and 30days and 6 month post partum
Measuring nipple pain and fissures, too much or too little milk
7 and 30days and 6 month post partum

Collaborators and Investigators

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

Sponsor

Danish Committee for Health Education

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Ingrid Nilsson, RN, MSA, IBCLC, Danish Committee for Health Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7111442

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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