COVID-19 vaccination during pregnancy not associated with any observable birth defects on ultrasound

Interview conducted by Aimee MolineuxApr 12 2022

Thought LeadersDr. Rachel RudermanDepartment of Obstetrics and GynecologyNorthwestern University

In our latest interview, News Medical speaks to Dr. Rachel Ruderman, a fourth-year resident at Northwestern University Feinberg School of Medicine, about her current research, which reveals no detectable link on ultrasound scans between COVID-19 vaccination and birth defects.

Please can you introduce yourself, tell us about your background in obstetrics, as well as what inspired your latest research?

My name is Rachel Ruderman. I am a 4^th year resident in obstetrics and gynecology at Northwestern University in Chicago. I love obstetrics - the changing physiology of pregnancy and how it impacts women and their children not only during pregnancy but after. Pregnancy can also expose significant future health risks and issues with social and economic support that really impact health.

Through the last two years of the pandemic, I have seen an amazing emergence of high-quality data and science on COVID in pregnancy and the development of lifesaving vaccines. Despite excellent evidence that COVID vaccines are safe and effective, many pregnant women have been hesitant to be vaccinated. Much of this stems back to pregnant people's initial exclusion from vaccine trials.

However, we now have a fund of research that supports the idea that the vaccine is safe and effective in pregnancy, while COVID during pregnancy can lead to worse maternal and fetal outcomes. Still - I noticed that a lot of my patients were hesitant to be vaccinated, and often cited their baby as the reason why. Thus, I wanted to look at whether getting the vaccine earlier in the pregnancy, during a key developmental time, as opposed to later in pregnancy or not at all, could be associated with an increased risk of birth defects.

In the U.S., 3 to 5% of births are impacted by birth defects, such as the baby’s heart not forming correctly. What are some of the major implications of birth defects, and why is it therefore important to study their potential causes and risk factors?

Birth defects are a large group of congenital abnormalities which include external structural defects (i.e. cleft lip) and internal structural defects  (i.e. cardiac abnormalities). Major defects are extremely taxing to the neonate, the parents, and the healthcare system. For example, certain congenital cardiac anomalies require several surgeries, prolonged inpatient admissions, and high costs to the parents as well as the healthcare system.

Tons of research focuses on what we can tell our patients are safe and unsafe during pregnancy, especially during the critical period of organ development (the "Teratogenic Window") so we can prevent the physical, mental, social, and economic impacts of birth defects. 

Your research analyzed electronic medical records, including ultrasound scans and COVID-19 vaccination records, to determine how the vaccine might affect the ultrasound scans of unborn babies. Can you explain in more detail how you conducted this research, and tell us about the findings you discovered?

The study involved looking at patients who had a routine mid-pregnancy anatomy scan and documentation about vaccination status. If a vaccine was administered in pregnancy, we recorded at what point in pregnancy it was given. In Illinois, this is more easily done because of a state-wide database that records vaccinations and shares them with providers across different hospital systems (I-CARE [illinois.gov]). From there, we looked at the patient's demographics (age, number of pregnancies, self-reported race, and ethnicity), as well as other health issues like high blood pressure and diabetes.

With all this information, we were able to see if the timing of vaccination impacted anomalies discovered on these mid-trimester ultrasounds. We also looked at whether pre-existing conditions (like diabetes) or age impacted the presence of anomalies. We found no difference in the rate of anomalies between those vaccinated during the "Teratogenic Window" and those either vaccinated later in pregnancy or those not vaccinated at all. There was no increased risk after adjusting for those pre-existing conditions. 

The present study builds on previous research with similar findings conducted by the U.S. Centers for Disease Control and Prevention (CDC). How does the present study build on and advance this pre-existing data?

The CDC has a database called the V-safe registry, which looks at outcomes from pregnant women who have received the vaccines. They found no difference in outcomes in those who got the vaccine compared to controls. However, people that got the COVID vaccine early on are different from those who declined vaccination, and our study gives more information on these different patients. We looked at patients who not only declined vaccination but also got vaccinated later in pregnancy and discovered the same outcomes. 

Pregnant patients were often excluded from the initial COVID-19 clinical vaccine trials. This left many doctors and patients alike wondering how the vaccine may affect pregnant individuals. What do we know now about undergoing COVID-19 vaccination during pregnancy that we didn’t know during the initial trial period?

We know that pregnant patients with COVID have an increased risk for ICU admission and intubation, as well as an increased risk for high blood pressure disorders of pregnancy, preterm birth, and needing a c-section. What we know now in addition is that the vaccines developed for the general population are safe and effective for pregnant patients and help dramatically decrease these risks. We also know that antibodies from the vaccine were higher than the antibodies people received from a COVID infection. 

Among an abundance of anti-vaccination misinformation being circulated online, why is it important to research and publicize evidence that vaccination is safe and beneficial for both mother and baby?

I have seen firsthand the misinformation online and how it has made my patients skeptical of getting the vaccine during pregnancy. The more we can counter this dangerous messaging with real, high-quality data, the better and safer our patients and their babies will be. It's so important to break down this information so the general public can really understand for themselves what the evidence is and make decisions that can benefit them in the long run. 

How do you believe that we can further increase vaccine confidence in pregnant individuals?

I have noticed that having conversations with my patients that are honest and open is the most helpful. I always ask people why they are hesitant or concerned, and then try to explain my recommendations using the significant amount of evidence we have on the Covid vaccine during pregnancy. I always check if my pregnant and postpartum patients are vaccinated and boosted. Talking with patients one on one and validating their concerns can go a long way.

What is next for you and your research?

Next year I will be a Maternal Fetal Medicine fellow at the University of Chicago taking care of high-risk pregnancies (sick moms and babies). I plan to do research on the postpartum period and would love to look at the postpartum experiences of women who were vaccinated against COVID or infected with COVID during pregnancy.

Where can readers find more information?

I would always recommend checking out reputable sites like the CDC and WHO. There's a lot of great COVID information for patients on ACOG's website (the American College of Obstetricians and Gynecologists). There's a lot of misinformation online so it's important to make sure the sources you're accessing are legitimate! 

Readers can find the full study at: https://news.northwestern.edu/stories/2022/03/covid-19-vaccine-not-associated-with-birth-defects/?fj=1

About the researcher

Rachel Ruderman is a native of Chicago. She attended the University of Michigan where she studied Global Health and received a Master of Public Health.  She returned to Chicago for medical school and stayed for residency at Northwestern. During her tenure at Northwestern, she has published on issues of accessing quality postpartum care.

Rachel also developed a women's health advocacy curriculum and established an infertility education program at Chicago's John H. Stroger Jr Hospital, a safety net hospital in the city.  Next year she will be a Maternal Fetal Medicine fellow at the University of Chicago where she plans to do research on the postpartum period.