Evaluation of Breastfeeding Support After Short Time Hospitalization

Study Overview
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Brief Summary
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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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: New Breastfeeding Counselling
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New breastfeeding programme<br>The breastfeeding programme consists of four core elements: breastfeeding is a parental task skin to skin contact during the first three days frequent breastfeeding at least 8 times a day 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<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>Breastfeeding counselling uses the national handbook of breastfeeding as reference | Other: Treatment as usual<br>* Health professionals offer the usual care for the breastfeeding mother<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents breastfeeding self efficacy |  | 7 days post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective breastfeeding | 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 |  | 7 and 30 days post partum and 6 month post partum | 
| Baby's morbidity | Measuring jaundice, dehydration, use of health facilities | 7 and 30 days post partum and 6 month post partum | 
| Breastfeeding problems | Measuring nipple pain and fissures, too much or too little milk | 7 and 30days and 6 month post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Breastfeeding self efficacy