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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
A case report described two pregnant women, aged 29−32 years, who developed COVID-19 during immunosuppressive treatment with prednisone, hydroxychloroquine or azathioprine for systemic lupus erythematosus (SLE) [routes, durations of treatments to reactions onsets and outcomes of ADRs not stated].
Patient 1: The 29-year-old multiparous pregnant woman, who had been receiving prednisone 25 mg/day, azathioprine 50 mg/day and hydroxychloroquine 200 mg/day for SLE, developed dyspnoea and frequent uterine contractions during the third trimester. Concomitantly, she had also been receiving carvedilol 12.5 mg/day. She was hospitalised, and SARS-CoV-2 infection was detected using reverse-transcriptase PCR. She was diagnosed with moderate COVID-19 secondary to immunosuppressive treatment with prednisone, hydroxychloroquine and azathioprine. At 28 weeks of gestation, she delivered a live neonate [sex of the neonate not stated], who developed severe pneumonia and sepsis [aetiologies unknown], which led to death on day 6 of life. SARS-CoV-2 test of the neonate was negative.
Patient 2: The 32-year-old multiparous pregnant woman, who had been receiving prednisone 5 mg/day, aspirin 80 mg/day and hydroxychloroquine 200 mg/day for SLE, developed intermittent fever and gum bleeding, along with a decrease in fetal movement during the third trimester. Therefore, she was hospitalised, and SARS-CoV-2 infection was detected using reverse-transcriptase PCR. She was diagnosed with mild COVID-19 secondary to immunosuppressive treatment with prednisone and hydroxychloroquine. On admission, intrauterine fetal death of 27 week old twins was detected. Therefore, labour and delivery were induced medically.
Reference
- Suilan KE, et al. Poor pregnancy and perinatal outcomes in SARS-CoV-2 infected patients with systemic lupus erythematosus. International Journal of Rheumatic Diseases 23 (Suppl. 1): 314 (plus poster), Oct 2020. Available from: URL: 10.1111/1756-185X.13985 [abstract] [DOI]