Navigating the Grey Zone for Antenatal Corticosteroids

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792112
• Other study ID #: H20-03071
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Jessica Liauw, MD
• Phone: 604-875-2424
• Email: jessica.liauw[@]phsa.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Decision Making, Shared
• Pregnancy
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Decision support tool
Decision support tool for late preterm antenatal corticosteroids

Locations

Country	Name	City	State
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in frequency of clinical counselling about late preterm antenatal corticosteroids.	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.	up to 8 months following implementation of the intervention.
Secondary	The change in quality of clinical counselling about late preterm antenatal corticosteroids as assessed by the COMRADE scale.	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.	up to 8 months following implementation of the intervention.