COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Evaluation of Breastfeeding Support After Short Time Hospitalization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01620723
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : February 13, 2017
TrygFonden, Denmark
Information provided by (Responsible Party):
Ingrid Nilsson, Danish Committee for Health Education

Brief 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.

Condition or disease Intervention/treatment Phase
Breastfeeding Other: New Breastfeeding Counselling Other: Treatment as usual Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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

Primary Outcome Measures :
  1. Parents breastfeeding self efficacy [ Time Frame: 7 days post partum ]

Secondary Outcome Measures :
  1. 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

  2. Duration of exclusive and full breastfeeding [ Time Frame: 7 and 30 days post partum and 6 month post partum ]
  3. Baby's morbidity [ Time Frame: 7 and 30 days post partum and 6 month post partum ]
    Measuring jaundice, dehydration, use of health facilities

  4. Breastfeeding problems [ Time Frame: 7 and 30days and 6 month post partum ]
    Measuring nipple pain and fissures, too much or too little milk

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01620723

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Ingrid Nilsson, RN, MSA, IBCLC Danish Committee for Health Education

Layout table for additonal information
Responsible Party: Ingrid Nilsson, Senior Project Coordinator, Danish Committee for Health Education Identifier: NCT01620723    
Other Study ID Numbers: 7111442
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Ingrid Nilsson, Danish Committee for Health Education:
Breastfeeding self efficacy