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 well-described.
Objectives: We implemented the CONSIGN protocol (COVID-19 infection and medicines in pregnancy) as part of an international collaboration to characterize COVID-19 severity and assess outpatient medication use patterns in 30 days prior or after COVID-19 diagnosis in pregnancies with COVID-19, and matched pregnancies without COVID-19.
Methods: Patients with live-birth deliveries who had a qualifying COVID-19 diagnosis or positive confirmed nucleic acid amplification test (NAAT) for SARS-CoV-2 were identified by pregnancy trimester and in 183 days pre-pregnancy period in FDA’s Sentinel System. These were matched on maternal age and select clinical conditions to pregnancies with no evidence of COVID-19 during pre-pregnancy or pregnancy. To temporally match pregnancies during the pandemic, estimated pregnancy start date in each matched pair was required to be within 14 days.
Results: From January 2020 to December 2021, we identified 14,475 pregnancies (mean age, 30 years) with COVID-19 either before or during pregnancy. Of these, 6,490 were diagnosed in the third trimester and fewer (N range: 2,155-2,924) during pre-pregnancy, first, or second trimester. Pregnant patients with COVID-19 had similar high-risk conditions but utilized more health services than pregnant patients without COVID-19. Only 7% of COVID-19 pregnancies in the third trimester (N=442) had severe COVID-19, defined as hospitalization with complications related to COVID-19 or requiring respiratory support. Less than 1% (N=36) had COVID-19 as the primary diagnosis. Among pregnancies with COVID-19, anti-inflammatory (12% vs. 1%), analgesic (10% vs. 3%), and antibacterial (13% vs. 11%) use was higher in the 30 days after COVID-19 compared to 30 days prior to diagnosis. Medications potentially used for COVID-19 treatment including NSAIDs (11% vs. 1%), dexamethasone (2% vs. 1%) and low molecular weight heparin (3% vs. 1%) were also dispensed more post than prior to COVID-19 diagnosis. Less variation was noted for medication use in pregnancies without COVID-19.
Conclusions: We characterized over 14,000 pregnancies with COVID-19 and compared them to pregnancies without COVID-19. Medications used for potential COVID-19 treatment varied between the pre- and post- COVID-19 period. We will assess the impact of COVID-19 on adverse infant outcomes and compare rates of infant outcomes among pregnancies with and without COVID-19.
