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Evaluation of Breastfeeding Support After Short Time Hospitalization

This study has been completed.
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: August 15, 2016
Last verified: August 2016
  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


Enrollment: 3541
Study Start Date: May 2013
Study Completion Date: March 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
Aalborg, Denmark, 9000
Sygehus Vendsyssel
Hjoerring, Denmark, 9800
Horsens sygehus
Horsens, Denmark, 8700
Kolding Sygehus
Kolding, Denmark, 6000
Nykøbing F Sygehuse
Nykøbing F, Denmark, 4800
Regionshospitalet Randers
Randers, Denmark, 8900
Haderslev/Sønderborg sygehus
Sønderborg, Denmark, 6400
Sygehus Thy-Mors
Thisted, Denmark, 7700
Regionshospitalet Viborg
Viborg, Denmark, 8800
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

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: August 15, 2016
Health Authority: Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on September 27, 2016