Baystate creates decision aid for doctors and pregnant women to consult
SPRINGFIELD, MA – Is it safe for pregnant women to get the coronavirus vaccine?
That’s a question that two Baystate Medical Center doctors contemplated together recently – one a primary care physician at Baystate Mason Square Neighborhood Health Center, who is also board certified in infectious diseases, and the other an OB/GYN.
Dr. Amanda Westlake learned in September that she was expecting her third child. As an infectious disease specialist, when she visited with her OB/GYN, Dr. Katie Barker of Baystate Wesson Women’s Group, she was already familiar with much of the emerging literature on pregnancy and COVID-19. It is concisely stated on the Centers for Disease Control and Prevention (CDC)website that:
“Based on what we know at this time, pregnant people are at an increased risk for severe illness from COVID-19 compared to non-pregnant people. Additionally, pregnant people with COVID-19 might be at increased risk for other adverse outcomes, such as preterm birth.”
But when the two doctors came together to discuss whether Dr. Westlake should get the coronavirus vaccine, the answer wasn’t that simple – there is no scientific study on whether or not the vaccine is safe for pregnant women.
“Pfizer did not include pregnant women in its clinical trials to establish the safety and efficacy of their vaccine (it is common in clinical trials to exclude pregnant women). That was unfortunate because our professional organization, the American College of Obstetricians and Gynecologists (ACOG) has long advocated for women to be involved in vaccine trials,” said Dr. Barker.
“As a result, we do not have specific data on which to make a decision about pregnant women receiving the vaccine. However, we have no reason now to suspect that it would work differently or be harmful to pregnant women, which is something I tell my patients every day,” she added.
And, when studies are completed on the vaccine’s effects on pregnant women now being inoculated against the virus, Dr. Barker said she would be surprised if they discover anything unexpected.
Recognizing that pregnant women everywhere would need guidance, the Shared Decision-Making: COVID Vaccination in Pregnancy working group at the University of Massachusetts Medical School – Baystate was created under the leadership of Dr. Elizabeth Schoenfeld, an Emergency Medicine physician at Baystate. Dr. Schoenfeld, a shared decision-making researcher in the hospital’s Institute for Healthcare Delivery and Population Science, has experience making decision aids to help patients make decisions together with their doctors. Because of the lack of evidence to guide recommendations for pregnant women, a shared decision aid was needed to help women understand the risks and benefits and the unknowns.
“Shared decision making helps patients understand their choices and come to an informed decision with their doctors about their care. It is a way for patients to have their voices heard when deciding what the next step in their medical care will be. And a decision aid is a tool to help facilitate a discussion between a doctor and patient such as, “Should I get the coronavirus vaccine,” said Dr. Schoenfeld.
The clinical researcher noted that “in general the vaccine is highly recommended and safe” and although there was no hard data available on pregnancy and the vaccine, it wasn’t as if “there was no evidence at all about the vaccine to share in an aid.”
“Certainly, for many pregnant women the pros outweigh the cons,” said Dr. Schoenfeld, who noted that when putting together the decision aid it was important to involve multiple stakeholders, such as maternal-fetal medicine experts, COVID experts, and pregnant healthcare workers.
The result is a 6-page decision aid on the Pfizer and Moderna vaccines that starts with the basics: “I’m pregnant. Should I get a COVID vaccine?” It discusses a woman’s options, the benefits and risks of getting an mRNA COVID vaccine, and other information to help pregnant women make an informed decision. There are also additional details about breastfeeding, noting the Society for Maternal-Fetal Medicine (SMFM) and the Academy of Breastfeeding Medicine (ABM) report that there is no reason to believe that the vaccine affects the safety of breastmilk.
Since completing the aid, it has been shared via Twitter and with various national professional networks such as maternal fetal medicine doctors, obstetricians, emergency medicine doctors, and medical informatics leaders. Based on feedback from those who have received the aid, it is being used at Boston Medical Center, Kaiser Southern California, Mass General Hospital, and in multiple other practices including Texas, and all around the country.
“We have received so much positive feedback. In fact, one woman from Costa Rica asked if we had a Spanish version of the document. We were able to quickly create Spanish and Russian versions and have made them available as well,” said Dr. Schoenfeld.
To view the latest version of the decision guide, visit:https://www.baystatehealth.org/covid19/vaccine/pregnancy
For more information about Baystate Health, visitbaystatehealth.org.
