Breastfeeding Planning Card Trial in Scotland

NCT ID: NCT06255015

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-07-31

Brief Summary

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This study evaluates the efficacy of a "breastfeeding toolkit" card delivered as part of antenatal care in promoting breastfeeding maintenance.

Detailed Description

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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

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Breastfeeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A regression discontinuity design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Breastfeeding toolkit card

Intervention Type DEVICE

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 planning card

50% of women will receive routine antenatal care only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women in NHS Grampian

Exclusion Criteria

None
Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Grampian

OTHER_GOV

Sponsor Role collaborator

University of Stirling

OTHER

Sponsor Role lead

Responsible Party

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David Comerford

Professor of Behavioural Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Comerford

Role: PRINCIPAL_INVESTIGATOR

Stirling University

Locations

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University of Stirling

Stirling, Stirlingshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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David Comerford

Role: CONTACT

01786 467370

Facility Contacts

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David Comerford

Role: primary

Alix Aitken-Arbuckle

Role: backup

Other Identifiers

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IRAS: 316125

Identifier Type: -

Identifier Source: org_study_id

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