Get the Benefits From the Start. Improving Breastfeeding
ConditionBreastfeeding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-100
SponsorSlagelse Hospital
About this trial
Breastfeeding is beneficial for the physical and mental health of mothers and infants alike.
Most new mothers in Denmark intend to breastfeed, however, a substantial proportion do not succeed to breastfeed as intended.
In Region Zealand, few women breastfeed than in the rest of Denmark in which may be related to a higher proportion of women being overweight, having socio-economic constraints and a low educational level, all associated with breastfeeding difficulties. There is limited knowledge on how to deliver a tailored support aimed at families at high risk of breastfeeding difficulties in a high-income country.
We plan to conduct a study aiming to strengthen breastfeeding support to families at risk of breastfeeding difficulties, delivering at Slagelse Hospital, across healthcare sectors, including obstetric and neonatal departments, primary care and civil society.
The study aims to develop, implement, and evaluate a supportive breastfeeding intervention with specific focus on families at high risk of complicated breastfeeding and early breastfeeding cessation - a prospective cohort study in Region Zealand, Denmark.
Potentially, results can help reducing inequality in health thus more families achieve exclusive breastfeeding and gain health benefits from breastfeeding
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All women giving birth at Slagelse Hospital and their infants during the study period
Age at 15 years and above
Disqualifiers
families with a planned placement of the infant in a fostercare
Trial population
Women giving birth at Slagelse Hospital and their actual infant
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Improved breastfeeding support
BehavioralCross-sectoral intervention to improve breastfeeding support among women giving birth at Slagelse Hospital, Region Zealand, Denmark
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Pre-implementation group0 interventions
Group B: Post-implementation group1 intervention
Trial outcomes
Primary outcomes
1
Rate of mother's self-reporting exclusive breastfeeding
Mothers who are exclusive breastfeeding in the post-implementation group, compared to the pre-implementation group (n/% of total). Exclusive breastfeeding is defined as exclusive fed at the breast after discharge from hospital. This means, that in addition to breastfeeding, supplements with water and similar and/or a or a maximum of one meal of breastmilk substitute or mothers expressed breastmilk per week.
Time frame
4 month postpartumSecondary outcomes
1
Duration of exclusive breastfeeding
Duration of mothers' self-reporting exclusive breastfeeding in the post-implementation group, compared to the pre-implementation group (days, median with IQR).
Time frame
0-12 month2
Duration of any breastfeeding
Duration of mothers' self-reporting any breastfeeding in the post-implementation group, compared to the pre-implementation group (days, median with IQR).
Time frame
0-12 month3
Rate of exclusive breastfeeding reported by the home-visiting nurse
Mothers who are exclusive breastfeeding in the post-implementation group, compared to the pre-implementation group. Reported from the Danish National cross-sectoral database at (n/% of total).
Time frame
4 months4
Any admission of the infant
Any admission of the infant to hospital or referral to a pediatric outpatient clinic compared with any breastfeeding in the post-implementation group, compared to the pre-implementation group (n/% of total).
Time frame
0-12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Slagelse Hospital
Lead sponsor
Center for Clinical Research and Prevention
Collaborator
Region Zealand
Collaborator
Steno Diabetes Center Sjaelland
Collaborator
Source ClinicalTrials.gov