Navigating the Grey Zone for Antenatal Corticosteroids

Not Applicable

• Conditions: Preterm Birth; Decision Making, Shared; Pregnancy
• Interventions: Behavioral: Decision support tool

• Registration Number: NCT04792112
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Status Verified: 2022-05
• Study Start: 2022-05-20
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guideline + decision support tool	Decision support tool	A decision support tool summarizing harms and benefits of late preterm antenatal corticosteroids will be integrated into the clinical practice guideline available to clinicians in the hospitals in the experimental arm.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Surrey Memorial Hospital; 🇨🇦 Surrey, British Columbia, Canada