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Navigating the Grey Zone for Antenatal Corticosteroids

Improving Clinical Practice Guidelines for Antenatal Corticosteroids: Incorporating a Decision Support Tool to Tackle the Uncertain Balance of Harms and Benefits

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04792112
Enrollment
460
Registered
2021-03-10
Start date
2022-05-20
Completion date
2024-02-01
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making, Shared, Pregnancy, Preterm Birth

Keywords

Antenatal corticosteroid

Brief summary

The purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.

Interventions

Decision support tool for late preterm antenatal corticosteroids

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Controlled before and after study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 year or older. * Delivered a live neonate at 34+0 to 36+6 weeks of gestation. * Speaks English. * Agrees to participate in the questionnaire during their first week post-partum. * Delivered at one of the six participating obstetrical hospitals.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
The change in frequency of clinical counselling about late preterm antenatal corticosteroids.up to 8 months following implementation of the intervention.The difference in the proportion of patients who delivered a neonate at 34+0 to 36+6 weeks' gestation who report having had a discussion about antenatal corticosteroids with their care provider pre-intervention versus post-intervention.

Secondary

MeasureTime frameDescription
The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.up to 8 months following implementation of the intervention.The difference in the average median score on the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) scale, among those that report having had a discussion about late preterm antenatal corticosteroids with their health care provider. We will use an adapted scale including 19 items, each of which are scored on a 5-point Likert scale. A higher score indicates better risk communication and treatment decision making effectiveness.

Countries

Canada

Contacts

Primary ContactJessica Liauw, MD
jessica.liauw@phsa.ca604-875-2424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026