Navigating the Grey Zone for Antenatal Corticosteroids

NCT04792112 | Unknown

• 1 other identifier: H20-03071
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

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.

Conditions

Decision Making, Shared; Pregnancy; Preterm Birth

Keywords

Antenatal corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Guideline + decision support tool

EXPERIMENTAL

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.

Behavioral: Decision support tool

Guideline only

NO INTERVENTION

Clinicians in the hospitals in the 'no-intervention' arm will have access to the standard guideline only (without the integrated decision support tool).

Interventions

Decision support tool BEHAVIORAL

Decision support tool for late preterm antenatal corticosteroids

Guideline + decision support tool

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

RECRUITING

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jessica Liauw, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Liauw, MD

CONTACT

604-875-2424; jessica.liauw@phsa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Controlled before and after study

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 10, 2021
• Study Start: May 20, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)