Evaluation of Breastfeeding Support After Short Time Hospitalization

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Danish Committee for Health Education
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Ingrid Nilsson, Danish Committee for Health Education
ClinicalTrials.gov Identifier:
NCT01620723
First received: June 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Breastfeeding
Other: New Breastfeeding Counselling
Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum

Resource links provided by NLM:


Further study details as provided by Danish Committee for Health Education:

Primary Outcome Measures:
  • Parents breastfeeding self efficacy [ Time Frame: 7 days post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effective breastfeeding [ Time Frame: 7 days post partum ] [ Designated as safety issue: Yes ]
    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

  • Duration of exclusive and full breastfeeding [ Time Frame: 7 and 30 days post partum and 6 month post partum ] [ Designated as safety issue: No ]
  • Baby's morbidity [ Time Frame: 7 and 30 days post partum and 6 month post partum ] [ Designated as safety issue: Yes ]
    Measuring jaundice, dehydration, use of health facilities

  • Breastfeeding problems [ Time Frame: 7 and 30days and 6 month post partum ] [ Designated as safety issue: No ]
    Measuring nipple pain and fissures, too much or too little milk


Estimated Enrollment: 1500
Study Start Date: May 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New breastfeeding counselling 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 Other: Treatment as usual
Health professionals offer the usual care for the breastfeeding mother

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620723

Locations
Denmark
Aalborg Sygehus Recruiting
Aalborg, Denmark, 9000
Contact: Birgitte Meier Jensen       bimej@rn.dk   
Sygehus Vendsyssel Recruiting
Hjoerring, Denmark, 9800
Contact: Nina C Haumann    +45 22625354    nch@rn.dk   
Horsens sygehus Recruiting
Horsens, Denmark, 8700
Contact: Zena Esteitiyeh       zenaesteitiyeh@yahoo.dk   
Kolding Sygehus Recruiting
Kolding, Denmark, 6000
Contact: Janni Skovlund       Janni.Skovshoved@slb.regionsyddanmark.dk   
Nykøbing F Sygehuse Recruiting
Nykøbing F, Denmark, 4800
Contact: Helle Andersen       hean@regionsjaelland.dk   
Regionshospitalet Randers Recruiting
Randers, Denmark, 8900
Contact: Lone Neumann    +45 78 42 11 03    loneneum@rm.dk   
Haderslev/Sønderborg sygehus Recruiting
Sønderborg, Denmark, 6400
Contact: Annette Rabe    +45 2895 2717    Annette.rabe@shs.regionsyddanmark.dk   
Sygehus Thy-Mors Recruiting
Thisted, Denmark, 7700
Contact: Joan Immersen Kjeldsen    +45 96 17 62 49    joan.kjeldsen@rn.dk   
Regionshospitalet Viborg Recruiting
Viborg, Denmark, 8800
Contact: Lotte Thrige    +45 78442520    Lotte.Thrige@rm.dk   
Sponsors and Collaborators
Danish Committee for Health Education
TrygFonden, Denmark
Investigators
Principal Investigator: Ingrid Nilsson, RN, MSA, IBCLC Danish Committee for Health Education
  More Information

No publications provided

Responsible Party: Ingrid Nilsson, Senior Project Coordinator, Danish Committee for Health Education
ClinicalTrials.gov Identifier: NCT01620723     History of Changes
Other Study ID Numbers: 7111442
Study First Received: June 12, 2012
Last Updated: May 6, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Danish Committee for Health Education:
Breastfeeding
Breastfeeding self efficacy

ClinicalTrials.gov processed this record on October 02, 2014