“Clinical characteristics, symptoms, management and health outcomes in 8,598 pregnant women diagnosed with COVID-19 compared to 27,510 with seasonal influenza in France, Spain and the US: a network cohort analysis”
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Abstract
OBJECTIVES
To describe comorbidities, symptoms at presentation, medication use, and 30-day outcomes after a diagnosis of COVID-19 in pregnant women, in comparison to pregnant women with influenza.
DESIGN
Multinational network cohort
SETTING
A total of 6 databases consisting of electronic medical records and claims data from France, Spain, and the United States.
PARTICIPANTS
Pregnant women with ≥ 1 year in contributing databases, diagnosed and/or tested positive, or hospitalized with COVID-19. The influenza cohort was derived from the 2017-2018 influenza season.
OUTCOMES
Baseline patient characteristics, comorbidities and presenting symptoms; 30-day inpatient drug utilization, maternal complications and pregnancy-related outcomes following diagnosis/hospitalization.
RESULTS
8,598 women diagnosed (2,031 hospitalized) with COVID-19 were included. Hospitalized women had, compared to those diagnosed, a higher prevalence sof pre-existing comorbidities including renal impairment (2.2% diagnosed vs 5.1% hospitalized) and anemia (15.5% diagnosed vs 21.3% hospitalized).
The ten most common inpatient treatments were systemic corticosteroids (29.6%), enoxaparin (24.0%), immunoglobulins (21.4%), famotidine (20.9%), azithromycin (18.1%), heparin (15.8%), ceftriaxone (7.9%), aspirin (7.0%), hydroxychloroquine (5.4%) and amoxicillin (3.5%).
Compared to 27,510 women with influenza, dyspnea and anosmia were more prevalent in those with COVID-19. Women with COVID-19 had higher frequency of cesarean-section (4.4% vs 3.1%), preterm delivery (0.9% vs 0.5%), and poorer maternal outcomes: pneumonia (12.0% vs 2.7%), ARDS (4.0% vs 0.3%) and sepsis (2.1% vs 0.7%). COVID-19 fatality was negligible (N<5 in each database respectively).
CONCLUSIONS
Comorbidities that were more prevalent with COVID-19 hospitalization (compared to COVID-19 diagnosed) in pregnancy included renal impairment and anemia. Multiple medications were used to treat pregnant women hospitalized with COVID-19, some with little evidence of benefit. Anosmia and dyspnea were indicative symptoms of COVID-19 in pregnancy compared to influenza, and may aid differential diagnosis. Despite low fatality, pregnancy and maternal outcomes were worse in COVID-19 than influenza.
WHAT IS ALREADY KNOWN ON THIS TOPIC
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Compared to non-pregnant women of reproductive age, pregnant women are less likely to experience typical COVID-19 symptoms, such as fever and myalgia.
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Obesity, high maternal age, and comorbid hypertension and diabetes are risk factors for severe COVID-19 among pregnant women.
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Despite relatively high rates of pneumonia and need for oxygen supplementation, fatality rates in pregnant women with COVID-19 are generally low (<1%).
WHAT THIS STUDY ADDS
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Although not often recorded, dyspnea and anosmia were more often seen in pregnant women with COVID-19 than in women with seasonal influenza, in 6 databases from 3 countries (US, France, Spain).
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Renal impairment and anemia were more common among hospitalized than diagnosed women with COVID-19 during pregnancy.
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Despite limited data on benefit-risk in pregnancy, a large number of medications were used for inpatient management of COVID-19 in pregnant women: approximately 1 in 3 received corticosteroids (some may have been given for a pregnancy-related indication rather than for COVID-19 treatment), 1 in 4 enoxaparin, and 1 in 5 immunoglobulin, famotidine and azithromycin.
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Compared to influenza, there was a higher frequency of pregnancy-related complications (cesarean section and preterm deliveries), as well as poorer maternal outcomes (pneumonia, acute respiratory distress syndrome, sepsis, acute kidney injury, and cardiovascular and thromboembolic events) seen in pregnant women diagnosed with COVID-19.
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SciScore for 10.1101/2020.10.13.20211821: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All the data partners obtained Institutional Review Board (IRB) approval or exemption to conduct this study. Randomization For the study of medications used for COVID-19, we assessed all medications included in at least two randomized controlled trials according to the COVID-19 clinical trial tracker12. Blinding not detected. Power Analysis not detected. Sex as a biological variable Data Sources: From the 18 databases contributing data to the CHARYBDIS Study to characterize the history of COVID-19, only those with data on pregnant women with a clinical diagnosis of COVID-19 or a SARS-CoV-2 positive test were included in this analysis. Table 2: Resources
… SciScore for 10.1101/2020.10.13.20211821: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All the data partners obtained Institutional Review Board (IRB) approval or exemption to conduct this study. Randomization For the study of medications used for COVID-19, we assessed all medications included in at least two randomized controlled trials according to the COVID-19 clinical trial tracker12. Blinding not detected. Power Analysis not detected. Sex as a biological variable Data Sources: From the 18 databases contributing data to the CHARYBDIS Study to characterize the history of COVID-19, only those with data on pregnant women with a clinical diagnosis of COVID-19 or a SARS-CoV-2 positive test were included in this analysis. Table 2: Resources
Software and Algorithms Sentences Resources Individual medications were categorized using the Anatomical Therapeutic Chemical (ATC) classification. ATCsuggested: NoneResults from OddPub: Thank you for sharing your code.
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Strengths and Limitations: Our study has both strengths and weaknesses. Firstly, the use of routinely collected data (EHR and claims) consistently leads to an underestimation of absolute risks due to incomplete recording of symptoms and potentially some comorbidities22. Secondly, the lack of information on or misclassification of indication for a given therapy makes it difficult to differentiate medications used for the treatment of COVID-19 vs the treatment of pregnancy-related indication. Corticosteroids are an example of a prescription commonly observed in our data that could be the consequence of respiratory distress due to COVID-19 but also potentially for the acceleration of fetal lung development in women at risk of preterm delivery. Similarly, hospitalization is reported primarily as a consequence of COVID-19 diagnosis, but it is also likely to be concomitant with a COVID-19 diagnosis. For example, in the US, many centers began universal screening of all pregnant women presenting to the hospital regardless of reason (i.e. spontaneous labor, schedule cesareans, or evaluation of other pregnancy related condition) or presence of symptoms after early reports from New York cited asymptomatic COVID-19 positive testing rates of 14-66%28, 29. Finally, disparities in data sources due to different countries and healthcare settings may result in important differences in coding practice, making comparisons between databases difficult and increasing ranges in the observed frequenc...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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