ClinicalTrials.gg
RecruitingNCT06255015CARRDSUpdated Feb 12, 2024

Breastfeeding Planning Card Trial in Scotland

An interventional study of Breastfeeding toolkit card in Breastfeeding, sponsored by University of Stirling. Recruiting at 1 site in United Kingdom. Open to female participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by University of Stirling · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
17 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breastfeeding

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03

In context

Breast Feeding

1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

University of Stirling is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women in NHS Grampian

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Breastfeeding toolkit card

    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.

    Device: Breastfeeding toolkit card

  • No intervention
    No planning card

    50% of women will receive routine antenatal care only.

Interventions

  • DeviceBreastfeeding toolkit card

    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.

06

What researchers measure

Primary outcomes

  1. breastfeeding rates at 6-8 weeks post-partum

    Proportion of women recorded as breastfeeding by their home visitor at 6-8 weeks post-partum

    Time frame: 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

    Time frame: 10-14 days

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Oct 2023, 7 months.

Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 7 months is below that.

Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
Feb 12, 2024
StartActual
Mar 1, 2023
Primary completionActual
Oct 31, 2023
CompletionEst.
Jul 31, 2024
Last update
Feb 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06255015
Lead sponsor
University of Stirling
Collaborators
NHS Grampian
Responsible party
David Comerford (Professor of Behavioural Science, University of Stirling) — Principal investigator
First posted
Feb 12, 2024
Start date
Mar 1, 2023
Primary completion
Oct 31, 2023
Completion
Jul 31, 2024 (estimated)
Last update
Feb 12, 2024

Study contacts

David Comerford
Contact
david.comerford@stir.ac.uk
01786 467370
David Comerford
principal investigator · Stirling University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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