NCT01620723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,541

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

June 12, 2012

Last Update Submit

February 10, 2017

Conditions

Breastfeeding

Keywords

BreastfeedingBreastfeeding self efficacy

Outcome Measures

Primary Outcomes (1)

  • Parents breastfeeding self efficacy

    7 days post partum

Secondary Outcomes (4)

  • Effective breastfeeding

    7 days post partum

  • Duration of exclusive and full breastfeeding

    7 and 30 days post partum and 6 month post partum

  • Baby's morbidity

    7 and 30 days post partum and 6 month post partum

  • Breastfeeding problems

    7 and 30days and 6 month post partum

Study Arms (2)

New breastfeeding programme

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

Breastfeeding counselling uses the national handbook of breastfeeding as reference

Other: Treatment as usual

Interventions

New Breastfeeding CounsellingOTHER

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.

New breastfeeding programme
Treatment as usualOTHER

Health professionals offer the usual care for the breastfeeding mother

Treatment as usual

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women (gestational week 35-36)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Aalborg Sygehus

Aalborg, 9000, Denmark

Location

Sygehus Vendsyssel

Hjørring, 9800, Denmark

Location

Horsens sygehus

Horsens, 8700, Denmark

Location

Kolding Sygehus

Kolding, 6000, Denmark

Location

Nykøbing F Sygehuse

Nykøbing Falster, 4800, Denmark

Location

Regionshospitalet Randers

Randers, 8900, Denmark

Location

Haderslev/Sønderborg sygehus

Sønderborg, 6400, Denmark

Location

Sygehus Thy-Mors

Thisted, 7700, Denmark

Location

Regionshospitalet Viborg

Viborg, 8800, Denmark

Location

Related Publications (1)

  • Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

    PMID: 34286512DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ingrid Nilsson, RN, MSA, IBCLC

    Danish Committee for Health Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Project Coordinator

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2016

Last Updated

February 13, 2017

Record last verified: 2017-02

Locations

DK(9)