About the Study

Antenatal corticosteroids are a medication given to pregnant women who might have a preterm birth to reduce the chance of their babies having breathing problems after delivery. Between 34 weeks to 36 weeks of pregnancy, it is unclear whether the benefits of the medication outweigh the harms, because babies generally have low risks of breathing problems after birth at these gestational ages. Clinical guidelines for this treatment are less clear at these later preterm ages, which makes it difficult for care providers and patients to decide whether to use it. As such, clinicians and patients need more support to navigate this grey zone.

Decision support tools that clearly state harms and benefits can sometimes help care providers and patients make decisions about whether a treatment is right for them. Our goal is to find out if including a decision support tool in clinical guidelines will improve how care providers discuss antenatal corticosteroids with patients who might deliver at 34 to 36 weeks of pregnancy. Patients who delivered at these preterm ages will be asked whether their care providers discussed antenatal corticosteroids with them, and we will see if they report having had better discussions with their care provider about this treatment decision after their doctor had access to the decision support tool within the clinical guideline. We will also ask doctors if and how this decision support tool impacts their counselling.

If integration of this tool does improve patient counselling, our work will serve as an effective template for improving other clinical guideline recommendations in obstetrics and gynecology that also have an unclear balance of risks and benefits. Our findings have the potential to transform and improve the way we implement these recommendations in day-to-day practice, thereby changing the way that practice guidelines are used across our field and increasing our capacity to provide evidence-based, patient-centered care for Canadian women and families.

You may be able to participate in this study if:

• You are 18 years of age or older
• You delivered a live infant between 34+0 weeks and 36+6 weeks of gestation at one of the six participating hospitals
• You are within one week postpartum
• You are able to communicate in English

If you have any questions or are interested in participating in this study, please contact us.

If you agree to take part in this study, you will complete a brief one-time interview with a member of our Study Team. This interview will take approximately 10-15 minutes to complete and will take place in person, over the telephone, or by video call, whichever you prefer. The interview will ask you about your experiences discussing the use of corticosteroids with your care team prior to your delivery.

Will choosing to participate or not affect the care I receive?
Deciding not to take part or deciding to leave the study later is entirely up to you and will not affect your or your baby’s health care in any way. If you do decide to participate, and there are any questions you are uncomfortable answering, you will not be required to answer them.

Are there any risks or harms of participating?
Participants might feel uncomfortable answering some questions about their experiences of clinical counselling around antenatal corticosteroids in pregnancy. You do not have to answer any questions that you are uncomfortable answering.

Are there any benefits to participating?
There may not be direct benefit to you from taking part in this study. We hope that the information learned from this study can be used in the future to benefit other people at risk of preterm deliveries by potentially improving treatment-related clinical counselling.

How much time will it take to participate?
This study involves a brief, one-time interview that will take 10-15 minutes and can be done in person, over the telephone, or by video call.

Will there be any costs to participate?
The only costs for you to participate may be any costs from your cell phone service provider(s) related to responding to a text message or completing the interview over the phone or video call (talk time/data usage). These costs will not be reimbursed. For completing the interview with a Study Team member, you will receive a gift card to a store in your community.

Will I be able to see the results of the study?
Yes. After the study is finished, the results will be published in a peer reviewed publication. They will also be made available on our study website and other public/social media forums associated with the University of British Columbia/the UBC Department of Obstetrics and Gynecology and the Society of Obstetricians and Gynaecologists of Canada. A description of this clinical trial is also available on http://www.ClinicalTrials.gov at NCT04792112. This site can be viewed at any time and may be updated to include a summary of the results once they are available. If you are interested, the Study Team can also forward the study results to you.

The Steering Committee provides oversight of Navigating the Grey Zone throughout the progress of the study.