BreastfeedingNCT01620723
Evaluation of Breastfeeding Support After Short Time Hospitalization
A study testing New Breastfeeding Counselling and Treatment as usual in people with Breastfeeding, run by Danish Committee for Health Education at 9 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- New Breastfeeding Counselling and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,541 participants
- Where
- 9 sitesDenmark
- Study dates
- May 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pregnant women (gestational week 35-36)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Aalborg Sygehus
Aalborg, 9000
Sygehus Vendsyssel
Hjørring, 9800
Horsens sygehus
Horsens, 8700
Kolding Sygehus
Kolding, 6000
Nykøbing F Sygehuse
Nykøbing Falster, 4800
Regionshospitalet Randers
Randers, 8900
Haderslev/Sønderborg sygehus
Sønderborg, 6400
Sygehus Thy-Mors
Thisted, 7700
Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum
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.
- Conditions
- Breastfeeding
- Being tested
- New Breastfeeding Counselling, Treatment as usual
- Keywords
- Breastfeeding, Breastfeeding self efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Treatment as usualOther
Health professionals offer the usual care for the breastfeeding mother
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: New Breastfeeding Counselling |
| Treatment as usual | Active comparator | Breastfeeding counselling uses the national handbook of breastfeeding as reference Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents breastfeeding self efficacy
Measured: 7 days post partum
Secondary outcomes (4)
Effective breastfeeding
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
Measured: 7 days post partum
Duration of exclusive and full breastfeeding
Measured: 7 and 30 days post partum and 6 month post partum
Baby's morbidity
Measuring jaundice, dehydration, use of health facilities
Measured: 7 and 30 days post partum and 6 month post partum
Breastfeeding problems
Measuring nipple pain and fissures, too much or too little milk
Measured: 7 and 30days and 6 month post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Committee for Health Education
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Ingrid Nilsson, Danish Committee for Health Education
- Investigators
- Ingrid Nilsson, RN, MSA, IBCLC, Principal investigator, Danish Committee for Health Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620723
- Sponsor's protocol ID
- 7111442
- Status last verified
- Feb 2017
- First submitted
- 12 Jun 2012
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34286512
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of a Theory and Evidence Based Programme for Establishing Effective Breastfeeding After Short Time Hospitalization Post Partum
- ClinicalTrials.gov ID
- NCT01620723
- Acronym / sponsor ID
- 7111442
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Breastfeeding self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,541 participants (actual)
- Lead sponsor
- Danish Committee for Health EducationUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New breastfeeding programme | Experimental | Other: New Breastfeeding CounsellingThe 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 |
| Treatment as usual | Active comparator | Other: Treatment as usualBreastfeeding counselling uses the national handbook of breastfeeding as reference |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women (gestational week 35-36)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Breastfeeding CounsellingAn 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. | Other | New breastfeeding programme |
| Treatment as usualHealth professionals offer the usual care for the breastfeeding mother | Other | Treatment as usual |
Primary outcome
Parents breastfeeding self efficacy
Time frame: 7 days post partum
4 secondary outcomes
Effective breastfeeding
Time frame: 7 days post partum
Duration of exclusive and full breastfeeding
Time frame: 7 and 30 days post partum and 6 month post partum
Baby's morbidity
Time frame: 7 and 30 days post partum and 6 month post partum
Breastfeeding problems
Time frame: 7 and 30days and 6 month post partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Derived from this study: PubMed 34286512Yonemoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Nilsson, RN, MSA, IBCLC principal investigator
Danish Committee for Health Education
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Breastfeeding Counselling and Treatment as usual in people with Breastfeeding, run by Danish Committee for Health Education at 9 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents breastfeeding self efficacy (time frame: 7 days post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01620723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.