Evaluation of Breastfeeding Support After Short Time Hospitalization

NCT ID: NCT01620723

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

New Breastfeeding Counselling

Intervention Type OTHER

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

Breastfeeding counselling uses the national handbook of breastfeeding as reference

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Health professionals offer the usual care for the breastfeeding mother

Interventions

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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.

Intervention Type OTHER

Treatment as usual

Health professionals offer the usual care for the breastfeeding mother

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Danish Committee for Health Education

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Nilsson

Senior Project Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid Nilsson, RN, MSA, IBCLC

Role: PRINCIPAL_INVESTIGATOR

Danish Committee for Health Education

Locations

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Aalborg Sygehus

Aalborg, , Denmark

Site Status

Sygehus Vendsyssel

Hjørring, , Denmark

Site Status

Horsens sygehus

Horsens, , Denmark

Site Status

Kolding Sygehus

Kolding, , Denmark

Site Status

Nykøbing F Sygehuse

Nykøbing Falster, , Denmark

Site Status

Regionshospitalet Randers

Randers, , Denmark

Site Status

Haderslev/Sønderborg sygehus

Sønderborg, , Denmark

Site Status

Sygehus Thy-Mors

Thisted, , Denmark

Site Status

Regionshospitalet Viborg

Viborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 34286512 (View on PubMed)

Other Identifiers

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7111442

Identifier Type: -

Identifier Source: org_study_id

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