BreastfeedingCARRDSNCT06255015
Breastfeeding Planning Card Trial in Scotland
A study testing Breastfeeding toolkit card in people with Breastfeeding, run by University of Stirling at 1 site in United Kingdom.
Trial summary
This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance. Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding toolkit card
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 31 Jul 2024
- 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 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women in NHS Grampian
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Stirling
Stirling, Stirlingshire, FK9 4LA
David Comerford, david.comerford@stir.ac.uk
Alix Aitken-Arbuckle, a.aitken-arbuckle@napier.ac.uk
About this study
Official title: Breastfeeding Planning Card Feasibility Study
This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance.
Read the detailed description
The project is an evaluation of an intervention that will start on January 1 2024.
From January 1 2024 through to March 31st 2024 midwives will present to patients attending their 24 week antenatal appointment a breastfeeding toolkit card.
The trial compares breastfeeding rates across patients who receive the card and those whose 24-week antenatal appointment occurred in the three months October 1 2023 - December 31 2023.
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding toolkit card
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding toolkit cardDevice
The card is delivered at 24 weeks and is also referred to in the 32 and 36 week antenatal meetings. It will also be referred to in the first 24 hours post-partum and in home visits.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding toolkit card | Active comparator | 50% of participants will be allocated to the intervention group, and receive a breastfeeding toolkit card at the 24 week appointment.
The Breastfeeding toolkit provides advice on circumventing common breastfeeding problems and contact details for breastfeeding support services. Receives: Device: Breastfeeding toolkit card |
| No planning card | No intervention | 50% of women will receive routine antenatal care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding rates at 6-8 weeks post-partum
Proportion of women recorded as breastfeeding by their home visitor at 6-8 weeks post-partum
Measured: 6-8 weeks
Secondary outcomes (1)
breastfeeding rates at 10-14 days post-partum
Proportion of women recorded as breastfeeding by their home visitor at 10-14 days post-partum
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Mar 2023
- Primary completion31 Oct 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- A regression discontinuity design.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Principal investigator, David Comerford, University of Stirling
- Investigators
- David Comerford, Principal investigator, Stirling University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255015
- Sponsor's protocol ID
- IRAS: 316125
- Acronym
- CARRDS
- Status last verified
- Feb 2024
- First submitted
- 28 Mar 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Planning Card Feasibility Study
- ClinicalTrials.gov ID
- NCT06255015
- Acronym / sponsor ID
- CARRDS / IRAS: 316125
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- 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.
This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance.
Detailed description
The project is an evaluation of an intervention that will start on January 1 2024.
From January 1 2024 through to March 31st 2024 midwives will present to patients attending their 24 week antenatal appointment a breastfeeding toolkit card.
The trial compares breastfeeding rates across patients who receive the card and those whose 24-week antenatal appointment occurred in the three months October 1 2023 - December 31 2023.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A regression discontinuity design.
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding toolkit card | Active comparator | Device: Breastfeeding toolkit card50% of participants will be allocated to the intervention group, and receive a breastfeeding toolkit card at the 24 week appointment. The Breastfeeding toolkit provides advice on circumventing common breastfeeding problems and contact details for breastfeeding support services. |
| No planning card | No intervention | –50% of women will receive routine antenatal care only. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women in NHS Grampian
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Breastfeeding toolkit cardThe card is delivered at 24 weeks and is also referred to in the 32 and 36 week antenatal meetings. It will also be referred to in the first 24 hours post-partum and in home visits. | Device | Breastfeeding toolkit card |
Primary outcome
breastfeeding rates at 6-8 weeks post-partum
Time frame: 6-8 weeks
Proportion of women recorded as breastfeeding by their home visitor at 6-8 weeks post-partum
1 secondary outcome
breastfeeding rates at 10-14 days post-partum
Time frame: 10-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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.
David Comerford principal investigator
Stirling University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding toolkit card in people with Breastfeeding, run by University of Stirling at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Comerford (01786 467370, david.comerford@stir.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breastfeeding rates at 6-8 weeks post-partum (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.