Evaluation of Breastfeeding Support After Short Time Hospitalization

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620723
• Other study ID #: 7111442
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: February 10, 2017
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Danish Committee for Health Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3541
• Est. completion date: March 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.
• Treatment as usual
Health professionals offer the usual care for the breastfeeding mother

Locations

Country	Name	City	State
Denmark	Aalborg Sygehus	Aalborg
Denmark	Sygehus Vendsyssel	Hjoerring
Denmark	Horsens sygehus	Horsens
Denmark	Kolding Sygehus	Kolding
Denmark	Nykøbing F Sygehuse	Nykøbing F
Denmark	Regionshospitalet Randers	Randers
Denmark	Haderslev/Sønderborg sygehus	Sønderborg
Denmark	Sygehus Thy-Mors	Thisted
Denmark	Regionshospitalet Viborg	Viborg

Sponsors (2)

Lead Sponsor	Collaborator
Danish Committee for Health Education	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents breastfeeding self efficacy		7 days post partum
Secondary	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
Secondary	Duration of exclusive and full breastfeeding		7 and 30 days post partum and 6 month post partum
Secondary	Baby's morbidity	Measuring jaundice, dehydration, use of health facilities	7 and 30 days post partum and 6 month post partum
Secondary	Breastfeeding problems	Measuring nipple pain and fissures, too much or too little milk	7 and 30days and 6 month post partum