NCT06255015

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

March 28, 2023

Last Update Submit

February 10, 2024

Conditions

Breastfeeding

Outcome Measures

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

    6-8 weeks

Secondary Outcomes (1)

  • breastfeeding rates at 10-14 days post-partum

    10-14 days

Study Arms (2)

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.

Device: Breastfeeding toolkit card

No planning card

NO INTERVENTION

50% of women will receive routine antenatal care only.

Interventions

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.

Breastfeeding toolkit card

Eligibility Criteria

Age17 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women in NHS Grampian
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women in NHS Grampian

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Stirling

Stirling, Stirlingshire, FK9 4LA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • David Comerford

    Stirling University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Comerford

CONTACT

01786 467370david.comerford@stir.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: A regression discontinuity design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Behavioural Science

Study Record Dates

First Submitted

March 28, 2023

First Posted

February 12, 2024

Study Start

March 1, 2023

Primary Completion

October 31, 2023

Study Completion

July 31, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)