Breastfeeding Planning Card Trial in Scotland (CARRDS)

February 10, 2024 updated by: David Comerford, University of Stirling

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women in NHS Grampian

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
No Intervention: No planning card
50% of women will receive routine antenatal care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breastfeeding rates at 10-14 days post-partum
Time Frame: 10-14 days
Proportion of women recorded as breastfeeding by their home visitor at 10-14 days post-partum
10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stirling

Collaborators

NHS Grampian

Investigators

  • Principal Investigator: David Comerford, Stirling University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

February 10, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRAS: 316125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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