Characteristics and Medication Use Patterns of Pregnancies with COVID-19 in the Sentinel System

Friday, August 26, 2022

2:45 PM – 3:00 PM CEST

Location: C1M2

Publication Number: 66

Background: Pregnancy may increase the risk of developing severe illness associated with COVID-19. Several studies have reported higher hospitalizations and complications among pregnant patients with COVID-19, but medication use in these patients has not been described.

Objectives: We implemented the CONSIGN study (COVID-19 infection and medicines in pregnancy), as part of an international collaboration across several countries, to assess the prevalence of medication use and characterize severity and clinical outcomes in pregnancies with COVID-19 compared to those without COVID-19 and to reproductive aged patients with COVID-19.

Methods: Patients with live-birth deliveries who had a qualifying COVID-19 diagnosis(es) or positive confirmed nucleic acid amplification test (NAAT) for SARS-CoV-2 were identified in 183 days pre-pregnancy and by trimester periods in FDA's Sentinel System. Pregnancies with COVID-19 were compared to 1) age-matched non-pregnant patients with COVID-19 and 2) pregnancies without COVID-19 on baseline clinical conditions, COVID-19 severity, and outpatient medication use.

Results: From January 2020 to May 2021, we identified 2,747 pregnancies (mean age, 32 years) with COVID-19 either before or during pregnancy. Of these, 1942 were diagnosed in the 3rd trimester and fewer (140-660) during pre-pregnancy, 1st, or 2nd trimester. These patients had more high-risk conditions and utilized more health services than pregnant patients without COVID-19, but otherwise appeared similar to age-matched non-pregnant COVID-19 cases. Around 39% of COVID-19 pregnancies in 3rd trimester (n-747) were hospitalized, but < 1% had COVID-19 as the primary diagnosis. Further,12% were hospitalized for obstetric reasons but had no COVID-19 diagnosis noted during same hospitalization. Among pregnancies with COVID-19, azithromycin (9.5%), corticosteroids (9.5%), and NSAIDs (2.6%) were commonly dispensed medications during pregnancy. A slightly lower prevalence of use was noted in pregnancies without COVID-19. But, the use of these medications was higher in non-pregnant COVID-19 patients, 15% azithromycin, 23% corticosteroid, and 11% NSAIDs. A higher proportion of preterm births (17.5% vs. 14.2%) and preeclampsia (9.4% vs. 8.4%) was noted in pregnancies with COVID-19 than those without COVID-19.

Conclusions: In this study, pregnancies with COVID-19 were more likely to have high-risk conditions and adverse maternal outcomes compared to pregnancies without COVID-19. Patterns of medications used for COVID-19 treatment varied by pregnancy status. We plan to compare medication use pattern prior to and after COVID-19 diagnosis or positive test in next analyses.

Presenting Author(s)

Mayura Shinde, DrPH

Harvard Medical School
Boston, Massachusetts, United States

Slides

Co-Author(s)

Jennifer Lyons, PhD

Research Scientist
Harvard Pilgrim Health Care Institute
Natick, Massachusetts, United States
SA

Susan Andrade

Meyers Primary Care Institute
Worcester, Massachusetts, United States
AC

Austin Cosgrove

Harvard Pilgrim Healthcare Institute, United States
JD

Jolene Damon

Harvard Pilgrim Healthcare Institute, United States
EM

Elizabeth Messenger-Jones, MSPH

Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute
Boston, MA, United States
DS

Danijela Stojanovic, PharmD, PhD

U.S. Food and Drug Administration
Silver Spring, MD, United States
BW

Ben Wong

U.S. Food and Drug Administration, United States
Leyla Sahin, MD

Deputy Director for Safety
US Food and Drug Administration
Silver Spring, Maryland, United States
YZ

Yueqin Zhao, PhD

US Food and Drug Administration, United States
Darren Toh, DSc, FISPE

Harvard Pilgrim Health Care Institute
Boston, Massachusetts, United States
WH

Wei Hua, MSc, MHS, MD, PhD

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, United States