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Newly diagnosed immune thrombocytopenia in a pregnant patient after coronavirus disease 2019 vaccination
case-report
Publication date (Electronic):
22 August 2021
Publisher:
John Wiley & Sons Australia, Ltd
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Abstract
Over 26 million cases of coronavirus disease 2019 (COVID‐19) have been reported in the United States with over 440 000 deaths. Despite COVID‐19 vaccine approval, pregnant women were excluded from clinical trials. We report a case of immune thrombocytopenia in the first trimester, which occurred 13 days after initiating the COVID‐19 vaccination series. Thorough evaluation, including hematology consultation, established the diagnosis. High‐dose oral corticosteroids were started, and she was discharged home with significant improvement in platelet count on her fourth day of hospitalization with no subsequent complications. We advocate that the benefits of COVID‐19 vaccination outweigh the risk of infection in pregnancy and that pregnant women should be included in clinical trials. Closer post‐vaccination surveillance may be warranted in the pregnant population pending further data.
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Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020
Laura Zambrano, Sascha Ellington, Penelope Strid … (2020)
Studies suggest that pregnant women might be at increased risk for severe illness associated with coronavirus disease 2019 (COVID-19) ( 1 , 2 ). This report provides updated information about symptomatic women of reproductive age (15–44 years) with laboratory-confirmed infection with SARS-CoV-2, the virus that causes COVID-19. During January 22–October 3, CDC received reports through national COVID-19 case surveillance or through the National Notifiable Diseases Surveillance System (NNDSS) of 1,300,938 women aged 15–44 years with laboratory results indicative of acute infection with SARS-CoV-2. Data on pregnancy status were available for 461,825 (35.5%) women with laboratory-confirmed infection, 409,462 (88.7%) of whom were symptomatic. Among symptomatic women, 23,434 (5.7%) were reported to be pregnant. After adjusting for age, race/ethnicity, and underlying medical conditions, pregnant women were significantly more likely than were nonpregnant women to be admitted to an intensive care unit (ICU) (10.5 versus 3.9 per 1,000 cases; adjusted risk ratio [aRR] = 3.0; 95% confidence interval [CI] = 2.6–3.4), receive invasive ventilation (2.9 versus 1.1 per 1,000 cases; aRR = 2.9; 95% CI = 2.2–3.8), receive extracorporeal membrane oxygenation (ECMO) (0.7 versus 0.3 per 1,000 cases; aRR = 2.4; 95% CI = 1.5–4.0), and die (1.5 versus 1.2 per 1,000 cases; aRR = 1.7; 95% CI = 1.2–2.4). Stratifying these analyses by age and race/ethnicity highlighted disparities in risk by subgroup. Although the absolute risks for severe outcomes for women were low, pregnant women were at increased risk for severe COVID-19–associated illness. To reduce the risk for severe illness and death from COVID-19, pregnant women should be counseled about the importance of seeking prompt medical care if they have symptoms and measures to prevent SARS-CoV-2 infection should be strongly emphasized for pregnant women and their families during all medical encounters, including prenatal care visits. Understanding COVID-19–associated risks among pregnant women is important for prevention counseling and clinical care and treatment. Data on laboratory-confirmed and probable COVID-19 cases † were electronically reported to CDC using a standardized case report form § or NNDSS ¶ as part of COVID-19 surveillance efforts. Data are reported by health departments and can be updated by health departments as new information becomes available. This analysis included cases initially reported to CDC during January 22–October 3, 2020, with data updated as of October 28, 2020. Cases were limited to those in symptomatic women aged 15–44 years in the United States with laboratory-confirmed infection (detection of SARS-CoV-2 RNA in a clinical specimen using a molecular amplification detection test). Information on demographic characteristics, pregnancy status, underlying medical conditions, symptoms, and outcomes was collected. Pregnancy status was ascertained by a pregnancy field on the COVID-19 case report form or through records linked to the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET) optional COVID-19 module** , †† ( 3 ). CDC ascertained symptom status either through a reported symptom status variable (symptomatic, asymptomatic, or unknown) or based on the presence of at least one specific symptom on the case report form. Outcomes with missing data were assumed not to have occurred. Crude and adjusted RRs and 95% CIs were calculated using modified Poisson regression. Overall and stratified risk ratios were adjusted for age (in years), race/ethnicity, and presence of diabetes, cardiovascular disease (including hypertension), and chronic lung disease. SAS (version 9.4; SAS Institute) was used to conduct all analyses. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. §§ During January 22–October 3, a total of 5,003,041 laboratory-confirmed cases of SARS-CoV-2 infection were reported to CDC as part of national COVID-19 case surveillance, including 1,300,938 (26.0%) cases in women aged 15–44 years. Data on pregnancy status were available for 461,825 (35.5%) women aged 15–44 years, 30,415 (6.6%) of whom were pregnant and 431,410 (93.4%) of whom were nonpregnant. Among all women aged 15–44 years with known pregnancy status, 409,462 (88.7%) were symptomatic, including 23,434 pregnant women, accounting for 5.7% of all symptomatic women with laboratory-confirmed COVID-19, and 386,028 nonpregnant women. Pregnant women were more frequently Hispanic/Latina (Hispanic) (29.7%) and less frequently non-Hispanic White (White) (23.5%) compared with nonpregnant women (22.6% Hispanic and 31.7% White). Among all women, cough, headache, muscle aches, and fever were the most frequently reported signs and symptoms; most symptoms were reported less frequently by pregnant women than by nonpregnant women (Table 1). TABLE 1 Demographic characteristics, signs and symptoms, and underlying medical conditions among symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 infection (N = 409,462),* ,† by pregnancy status — United States, January 22–October 3, 2020 Characteristic No. (%) of symptomatic women Pregnant (n = 23,434) Nonpregnant (n = 386,028) Total (N = 409,462) Age group, yrs 15–24 6,463 (27.6) 133,032 (34.5) 139,495 (34.1) 25–34 12,951 (55.3) 131,835 (34.2) 144,786 (35.4) 35–44 4,020 (17.2) 121,161 (31.4) 125,181 (30.6) Race/Ethnicity § Hispanic or Latina, any race 6,962 (29.7) 85,618 (22.2) 92,580 (22.6) AI/AN, non-Hispanic 113 (0.5) 1,652 (0.4) 1,765 (0.4) Asian, non-Hispanic 560 (2.4) 8,605 (2.2) 9,165 (2.2) Black, non-Hispanic 3,387 (14.5) 54,185 (14.0) 57,572 (14.1) NHPI, non-Hispanic 119 (0.5) 1,526 (0.4) 1,645 (0.4) White, non-Hispanic 5,508 (23.5) 124,305 (32.2) 129,813 (31.7) Multiple or other race, non-Hispanic 726 (3.1) 12,341 (3.2) 13,067 (3.2) Signs and symptoms Known status of individual signs and symptoms¶ 10,404 174,198 184,602 Cough 5,230 (50.3) 89,422 (51.3) 94,652 (51.3) Fever** 3,328 (32.0) 68,536 (39.3) 71,864 (38.9) Muscle aches 3,818 (36.7) 78,725 (45.2) 82,543 (44.7) Chills 2,537 (24.4) 50,836 (29.2) 53,373 (28.9) Headache 4,447 (42.7) 95,713 (54.9) 100,160 (54.3) Shortness of breath 2,692 (25.9) 43,234 (24.8) 45,926 (24.9) Sore throat 2,955 (28.4) 60,218 (34.6) 63,173 (34.2) Diarrhea 1,479 (14.2) 38,165 (21.9) 39,644 (21.5) Nausea or vomiting 2,052 (19.7) 28,999 (16.6) 31,051 (16.8) Abdominal pain 870 (8.4) 16,123 (9.3) 16,993 (9.2) Runny nose 1,328 (12.8) 22,750 (13.1) 24,078 (13.0) New loss of taste or smell†† 2,234 (21.5) 43,256 (24.8) 45,490 (24.6) Fatigue 1,404 (13.5) 29,788 (17.1) 31,192 (16.9) Wheezing 172 (1.7) 3,743 (2.1) 3,915 (2.1) Chest pain 369 (3.5) 7,079 (4.1) 7,448 (4.0) Underlying medical conditions Known underlying medical condition status§§ 7,795 160,065 167,860 Diabetes mellitus 427 (5.5) 6,119 (3.8) 6,546 (3.9) Cardiovascular disease 304 (3.9) 7,703 (4.8) 8,007 (4.8) Chronic lung disease 506 (6.5) 9,185 (5.7) 9,691 (5.8) Chronic renal disease 18 (0.2) 680 (0.4) 698 (0.4) Chronic liver disease 17 (0.2) 350 (0.2) 367 (0.2) Immunocompromised condition 124 (1.6) 2,496 (1.6) 2,620 (1.6) Neurologic disorder, neurodevelopmental disorder, or intellectual disability 44 (0.6) 1,097 (0.7) 1,141 (0.7) Psychiatric disorder 62 (0.8) 1,139 (0.7) 1,201 (0.7) Autoimmune disorder 26 (0.3) 515 (0.3) 541 (0.3) Severe obesity¶¶ 174 (2.2) 1,810 (1.1) 1,984 (1.2) Abbreviations: AI/AN = American Indian or Alaska Native; NHPI = Native Hawaiian or Other Pacific Islander. * Women with known pregnancy status, representing 52% of 783,072 total cases among symptomatic women aged 15–44 years. † All statistical comparisons were significant at α 100.4°F [38°C] or subjective), cough, shortness of breath, wheezing, difficulty breathing, chills, rigors, myalgia, rhinorrhea, sore throat, chest pain, nausea or vomiting, abdominal pain, headache, fatigue, diarrhea (three or more loose stools in a 24-hour period), new olfactory or taste disorder, or other symptom not otherwise specified on the form. ** Patients were included if they had information for either measured or subjective fever variables and were considered to have a fever if “yes” was indicated for either variable. †† New olfactory and taste disorder has only been included on the CDC’s Human Infection with 2019 Novel Coronavirus Case Report Form since May 5, 2020. Therefore, data might be underreported for this symptom. §§ Status was classified as “known” if any of the following conditions were noted as present or absent on the CDC’s Human Infection with 2019 Novel Coronavirus Case Report Form: diabetes mellitus, cardiovascular disease (including hypertension), severe obesity (body mass index ≥40 kg/m2), chronic renal disease, chronic liver disease, chronic lung disease, immunosuppressive condition, autoimmune condition, neurologic condition (including neurodevelopmental, intellectual, physical, visual, or hearing impairment), psychological/psychiatric condition, and other underlying medical condition not otherwise specified. ¶¶ Defined as body mass index ≥40 kg/m2. Compared with nonpregnant women, pregnant women more frequently were admitted to an ICU (10.5 versus 3.9 per 1,000 cases; aRR = 3.0; 95% CI = 2.6–3.4), received invasive ventilation (2.9 versus 1.1 per 1,000 cases; aRR = 2.9; 95% CI = 2.2–3.8) and received ECMO (0.7 versus 0.3 per 1,000 cases; aRR = 2.4; 95% CI = 1.5–4.0). Thirty-four deaths (1.5 per 1,000 cases) were reported among 23,434 symptomatic pregnant women, and 447 (1.2 per 1,000 cases) were reported among 386,028 nonpregnant women, reflecting a 70% increased risk for death associated with pregnancy (aRR = 1.7; 95% CI = 1.2–2.4). Irrespective of pregnancy status, ICU admissions, receipt of invasive ventilation, and death occurred more often among women aged 35–44 years than among those aged 15–24 years (Table 2). Whereas non-Hispanic Black or African American (Black) women made up 14.1% of women included in this analysis, they represented 176 (36.6%) deaths overall, including nine of 34 (26.5%) deaths among pregnant women and 167 of 447 (37.4%) deaths among nonpregnant women. TABLE 2 Intensive care unit (ICU) admissions, receipt of invasive ventilation, receipt of extracorporeal membrane oxygenation (ECMO), and deaths among symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 (N = 409,462), by pregnancy status, age, race/ethnicity, and underlying health conditions — United States, January 22–October 3, 2020 Outcome*/Characteristic No. (per 1,000 cases) of symptomatic women Risk ratio (95% CI) Pregnant (n = 23,434) Nonpregnant (n = 386,028) Crude† Adjusted†,§ ICU admission¶ All 245 (10.5) 1,492 (3.9) 2.7 (2.4–3.1) 3.0 (2.6–3.4) Age group, yrs 15–24 49 (7.6) 244 (1.8) 4.1 (3.0–5.6) 3.9 (2.8–5.3) 25–34 118 (9.1) 467 (3.5) 2.6 (2.1–3.1) 2.4 (2.0–3.0) 35–44 78 (19.4) 781 (6.4) 3.0 (2.4–3.8) 3.2 (2.5–4.0) Race/Ethnicity Hispanic or Latina 89 (12.8) 429 (5.0) 2.6 (2.0–3.2) 2.8 (2.2–3.5) AI/AN, non-Hispanic 0 (0) 13 (7.9) NA NA Asian, non-Hispanic 20 (35.7) 52 (6.0) 5.9 (3.6–9.8) 6.6 (4.0–11.0) Black, non-Hispanic 46 (13.6) 334 (6.2) 2.2 (1.6–3.0) 2.8 (2.0–3.8) NHPI, non-Hispanic 5 (42.0) 22 (14.4) 2.9 (1.1–7.6) 3.7 (1.3–10.1) White, non-Hispanic 31 (5.6) 348 (2.8) 2.0 (1.4–2.9) 2.3 (1.6–3.3) Multiple or other race, non-Hispanic 8 (11.0) 37 (3.0) 3.7 (1.7–7.9) 4.1 (1.9–8.9) Unknown/Not reported 46 (7.6) 257 (2.6) 2.9 (2.1–3.9) 3.4 (2.5–4.7) Underlying health conditions Diabetes 25 (58.5) 274 (44.8) 1.3 (0.9–1.9) 1.5 (1.0–2.2) CVD** 13 (42.8) 247 (32.1) 1.3 (0.8–2.3) 1.5 (0.9–2.6) Chronic lung disease 15 (29.6) 179 (19.5) 1.5 (0.9–2.6) 1.7 (1.0–2.8) Invasive ventilation†† All 67 (2.9) 412 (1.1) 2.7 (2.1–3.5) 2.9 (2.2–3.8) Age group, yrs 15–24 11 (1.7) 68 (0.5) 3.3 (1.8–6.3) 3.0 (1.6–5.7) §§ 25–34 30 (2.3) 123 (0.9) 2.5 (1.7–3.7) 2.5 (1.6–3.7) §§ 35–44 26 (6.5) 221 (1.8) 3.5 (2.4–5.3) 3.6 (2.4–5.4) Race/Ethnicity Hispanic or Latina 33 (4.7) 143 (1.7) 2.8 (1.9–4.1) 3.0 (2.1–4.5) AI/AN, non-Hispanic 0 (0) 5 (3.0) NA NA Asian, non-Hispanic 4 (7.1) 19 (2.2) NA NA Black, non-Hispanic 10 (3) 86 (1.6) 1.9 (1.0–3.6) 2.5 (1.3–4.9) NHPI, non-Hispanic 4 (33.6) 10 (6.6) NA NA White, non-Hispanic 12 (2.2) 102 (0.8) 2.7 (1.5–4.8) 3.0 (1.7–5.6) Multiple or other race, non-Hispanic 0 (0) 8 (0.6) NA NA Unknown/Not reported 4 (0.7) 39 (0.4) NA NA Underlying health conditions Diabetes 10 (23.4) 98 (16.0) 1.5 (0.8–2.8) 1.7 (0.9–3.3) CVD** 6 (19.7) 82 (10.6) 1.9 (0.8–4.2) 1.9 (0.8–4.5) ¶¶ Chronic lung disease 4 (7.9) 50 (5.4) NA NA ECMO*** All 17 (0.7) 120 (0.3) 2.3 (1.4–3.9) 2.4 (1.5–4.0) Age group,yrs 15–24 6 (0.9) 31 (0.2) 4.0 (1.7–9.5) NA††† 25–34 7 (0.5) 35 (0.3) 2.0 (0.9–4.6) 2.0 (0.9–4.4) §§ 35–44 4 (1.0) 54 (0.4) NA NA Race/Ethnicity Hispanic or Latina 6 (0.9) 35 (0.4) 2.1 (0.9–5.0) 2.4 (1.0–5.9) AI/AN, non-Hispanic 0 (0) 1 (0.6) NA NA Asian, non-Hispanic 0 (0) 1 (0.1) NA NA Black, non-Hispanic 5 (1.5) 30 (0.6) 2.7 (1.0–6.9) 2.9 (1.1–7.3) NHPI, non-Hispanic 0 (0) 2 (1.3) NA NA White, non-Hispanic 4 (0.7) 29 (0.2) NA NA Multiple or other race, non-Hispanic 0 (0) 3 (0.2) NA NA Unknown/Not reported 2 (0.3) 19 (0.2) NA NA Underlying health conditions Diabetes 1 (2.3) 13 (2.1) NA NA CVD** 1 (3.3) 20 (2.6) NA NA Chronic lung disease 1 (2.0) 20 (2.2) NA NA Death§§§ All 34 (1.5) 447 (1.2) 1.3 (0.9–1.8) 1.7 (1.2–2.4) Age group, yrs 15–24 2 (0.3) 40 (0.3) NA NA 25–34 15 (1.2) 125 (0.9) 1.2 (0.7–2.1) 1.2 (0.7–2.1) 35–44 17 (4.2) 282 (2.3) 1.8 (1.1–3.0) 2.0 (1.2–3.2) Race/Ethnicity Hispanic or Latina 14 (2.0) 87 (1.0) 2.0 (1.1–3.5) 2.4 (1.3–4.3) AI/AN, non-Hispanic 0 (0) 5 (3.0) NA NA Asian, non-Hispanic 1 (1.8) 11 (1.3) NA NA Black, non-Hispanic 9 (2.7) 167 (3.1) 0.9 (0.4–1.7) 1.4 (0.7–2.7) NHPI, non-Hispanic 2 (16.8) 6 (3.9) NA NA White, non-Hispanic 3 (0.5) 83 (0.7) NA NA Multiple or other race, non-Hispanic 0 (0) 12 (1.0) NA NA Unknown/Not reported 5 (0.8) 76 (0.8) 1.1 (0.4–2.6) 1.4 (0.6–3.6) Underlying health conditions Diabetes 6 (14.1) 78 (12.7) 1.1 (0.5–2.5) 1.5 (0.6–3.5) ¶¶¶ CVD** 7 (23.0) 89 (11.6) 2.0 (0.9–4.3) 2.2 (1.0–4.8)**** Chronic lung disease 1 (2.0) 37 (4.0) NA NA Abbreviations: AI/AN = American Indian/Alaska Native; CI = confidence interval; CVD = cardiovascular disease; NA = not applicable; NHPI = Native Hawaiian or Other Pacific Islander. * Percentages calculated among total in pregnancy status group. † Crude and adjusted risk ratios were not calculated for cell sizes <5. § Adjusted for age (continuous variable, in years), categorical race/ethnicity variable, and dichotomous indicators for diabetes, cardiovascular disease, and chronic lung disease. ¶ A total of 17,007 (72.6%) symptomatic pregnant women and 291,539 (75.5%) symptomatic nonpregnant women were missing information on ICU admission status; however, while hospital admission status was not separately analyzed, hospitalization status was missing for 2,393 (10.2%) symptomatic pregnant women and 35,624 (9.2%) of symptomatic nonpregnant women, and no hospital admission was reported for 16,672 (71.1%) pregnant and 337,414 (87.4%) nonpregnant women. Therefore, in the absence of reported hospital admissions, women with missing ICU admission information were assumed to have not been admitted to the ICU. ** Cardiovascular disease also accounts for presence of hypertension. †† A total of 17,903 (76.4%) pregnant women and 299,413 (77.6%) nonpregnant women were missing information regarding receipt of invasive ventilation and were assumed to have not received it. §§ Adjusted for the presence of diabetes, CVD, and chronic lung disease only, and removed race/ethnicity from adjustment set because of model convergence issues . ¶¶ Adjusted for the presence of diabetes and chronic lung disease and age as a continuous covariate only and removed race/ethnicity from adjustment set because of model convergence issues. *** A total of 18,246 (77.9%) pregnant women and 298,608 (77.4%) nonpregnant women were missing information for receipt of ECMO and were assumed to have not received ECMO. ††† Model failed to converge even after adjustment for a reduced set of covariates. §§§ A total of 5,152 (22.0%) pregnant women and 66,346 (17.2%) nonpregnant women were missing information on death and were assumed to have survived. ¶¶¶ Adjusted for the presence of CVD and chronic lung disease and age as a continuous variable. **** Adjusted for presence of diabetes and chronic lung disease and age as a continuous variable. Increased risk for ICU admission among pregnant women was observed for all strata but was particularly notable among non-Hispanic Asian (Asian) women (aRR = 6.6; 95% CI = 4.0–11.0) and non-Hispanic Native Hawaiian/Pacific Islander women (aRR = 3.7; 95% CI = 1.3–10.1). Risk for receiving invasive ventilation among pregnant women aged 15–24 years was 3.0 times that of nonpregnant women (95% CI = 1.6–5.7), and among pregnant women aged 35–44 years was 3.6 times that of nonpregnant women (95% CI = 2.4–5.4). In addition, among Hispanic women, pregnancy was associated with 2.4 times the risk for death (95% CI = 1.3-4.3) (Table 2). Discussion Although the absolute risks for severe COVID-19–associated outcomes among women were low, pregnant women were at significantly higher risk for severe outcomes compared with nonpregnant women. This finding might be related to physiologic changes in pregnancy, including increased heart rate and oxygen consumption, decreased lung capacity, a shift away from cell-mediated immunity, and increased risk for thromboembolic disease ( 4 , 5 ). Compared with the initial report of these data ( 1 ), in which increased risk for ICU admissions and invasive ventilation among pregnant women was reported, this analysis includes nearly five times the number of symptomatic women and a higher proportion of women with known pregnancy status (36% versus 28%). Further, to avoid including pregnant women who were tested as part of asymptomatic screening practices at the delivery hospitalization, this analysis was limited to symptomatic women. In this analysis 5.7% of symptomatic women aged 15–44 years with COVID-19 were pregnant, corresponding to the anticipated proportion of 5% of the population at any point in time. ¶¶ , *** Whereas increased risk for severe disease related to pregnancy was apparent in nearly all stratified analyses, pregnant women aged 35–44 years with COVID-19 were nearly four times as likely to require invasive ventilation and twice as likely to die than were nonpregnant women of the same age. Among symptomatic pregnant women with COVID-19 for whom race/ethnicity was reported, 30% were Hispanic and 24% were White, differing from the overall reported racial/ethnic distribution of women who gave birth in 2019 (24% Hispanic and 51% White). ††† Pregnant Asian and Native Hawaiian/Pacific Islander women appeared to be at disproportionately greater risk for ICU admission. Hispanic pregnant women of any race not only experienced a disproportionate risk for SARS-CoV-2 infection but also a higher risk for death compared with nonpregnant Hispanic women. Regardless of pregnancy status, non-Hispanic Black women experienced a disproportionate number of deaths relative to their distribution among reported cases. This analysis highlights racial and ethnic disparities in both risk for infection and disease severity among pregnant women, indicating a need to address potential drivers of risk in these populations. The findings in this report are subject to at least three limitations. First, national case surveillance data for COVID-19 are voluntarily reported to CDC and rely on health care providers and jurisdictional public health agencies to share information for patients who meet standard case definitions. The mechanism used to report cases and the capacity to investigate cases varies across jurisdictions. §§§ Thus, case information is limited or unavailable for a portion of detected COVID-19 cases, and reported case data might be updated at any time. This analysis was restricted to women with known age; however, pregnancy status was missing for over one half (64.5%) of reported cases, and among those with known pregnancy status, data on race/ethnicity were missing for approximately 25% of cases, and information on symptoms and underlying conditions was missing for approximately one half. Second, when estimating the proportion of cases with severe outcomes, the observational data collected through passive surveillance might be subject to reporting bias, wherein preferential ascertainment of severe cases is likely ( 6 , 7 ); therefore, the frequency of reported outcomes incorporates a denominator of all cases as a conservative estimate. Finally, severe outcomes might require additional time to be ascertained. To account for this, a time lag was incorporated, such that data reported as of October 28, 2020, were used for cases reported as of October 3. This analysis supports previous findings that pregnancy is associated with increased risk for ICU admission and receipt of invasive ventilation among women of reproductive age with COVID-19 ( 1 , 2 ). In the current report, an increased risk for receiving ECMO and death was also observed, which are two additional important markers of COVID-19 severity that support previous findings. In comparison to influenza, a recent meta-analysis found no increased risk for ICU admission or death among pregnant women with seasonal influenza ( 8 ). However, data from previous influenza pandemics, including 2009 H1N1, have shown that pregnant women are at increased risk for severe outcomes including death and the absolute risks for severe outcomes were higher than in this study of COVID-19 during pregnancy ( 9 ). Longitudinal surveillance and cohort studies among pregnant women with COVID-19, including information about pregnancy outcomes, are necessary to understand the full spectrum of maternal and neonatal outcomes associated with COVID-19 in pregnancy. CDC, in collaboration with health departments, has adapted SET-NET to collect pregnancy-related information and pregnancy and neonatal outcomes among women with COVID-19 during pregnancy ¶¶¶ ( 3 ). Understanding the risk posed by SARS-CoV-2 infection in pregnant women can inform clinical practice, risk communication, and medical countermeasure allocation. Pregnant women should be informed of their risk for severe COVID-19–associated illness and the warning signs of severe COVID-19.**** To minimize the risk for acquiring SARS-CoV-2 infection, pregnant women should limit unnecessary interactions with persons who might have been exposed to or are infected with SARS-CoV-2, including those within their household, †††† as much as possible. §§§§ When going out or interacting with others, pregnant women should wear a mask, social distance, avoid persons who are not wearing a mask, and frequently wash their hands. In addition, pregnant women should take measures to ensure their general health, including staying up to date with annual influenza vaccination and prenatal care. Providers who care for pregnant women should be familiar with guidelines for medical management of COVID-19, including considerations for management of COVID-19 in pregnancy. ¶¶¶¶ , ***** Additional data from surveillance and cohort studies on COVID-19 severity during pregnancy are necessary to inform messaging and patient counseling. Summary What is already known about this topic? Limited information suggests that pregnant women with COVID-19 might be at increased risk for severe illness compared with nonpregnant women. What is added by this report? In an analysis of approximately 400,000 women aged 15–44 years with symptomatic COVID-19, intensive care unit admission, invasive ventilation, extracorporeal membrane oxygenation, and death were more likely in pregnant women than in nonpregnant women. What are the implications for public health practice? Pregnant women should be counseled about the risk for severe COVID-19–associated illness including death; measures to prevent infection with SARS-CoV-2 should be emphasized for pregnant women and their families. These findings can inform clinical practice, risk communication, and medical countermeasure allocation.
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Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–June 7, 2020
Sascha Ellington, Penelope Strid, Van Tong … (2020)
As of June 16, 2020, the coronavirus disease 2019 (COVID-19) pandemic has resulted in 2,104,346 cases and 116,140 deaths in the United States.* During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections ( 1 , 2 ). To date, data to assess the prevalence and severity of COVID-19 among pregnant U.S. women and determine whether signs and symptoms differ among pregnant and nonpregnant women are limited. During January 22–June 7, as part of COVID-19 surveillance, CDC received reports of 326,335 women of reproductive age (15–44 years) who had positive test results for SARS-CoV-2, the virus that causes COVID-19. Data on pregnancy status were available for 91,412 (28.0%) women with laboratory-confirmed infections; among these, 8,207 (9.0%) were pregnant. Symptomatic pregnant and nonpregnant women with COVID-19 reported similar frequencies of cough (>50%) and shortness of breath (30%), but pregnant women less frequently reported headache, muscle aches, fever, chills, and diarrhea. Chronic lung disease, diabetes mellitus, and cardiovascular disease were more commonly reported among pregnant women than among nonpregnant women. Among women with COVID-19, approximately one third (31.5%) of pregnant women were reported to have been hospitalized compared with 5.8% of nonpregnant women. After adjusting for age, presence of underlying medical conditions, and race/ethnicity, pregnant women were significantly more likely to be admitted to the intensive care unit (ICU) (aRR = 1.5, 95% confidence interval [CI] = 1.2–1.8) and receive mechanical ventilation (aRR = 1.7, 95% CI = 1.2–2.4). Sixteen (0.2%) COVID-19–related deaths were reported among pregnant women aged 15–44 years, and 208 (0.2%) such deaths were reported among nonpregnant women (aRR = 0.9, 95% CI = 0.5–1.5). These findings suggest that among women of reproductive age with COVID-19, pregnant women are more likely to be hospitalized and at increased risk for ICU admission and receipt of mechanical ventilation compared with nonpregnant women, but their risk for death is similar. To reduce occurrence of severe illness from COVID-19, pregnant women should be counseled about the potential risk for severe illness from COVID-19, and measures to prevent infection with SARS-CoV-2 should be emphasized for pregnant women and their families. Data on laboratory-confirmed and probable COVID-19 cases † were electronically reported to CDC using a standardized case report form § or through the National Notifiable Diseases Surveillance System ¶ as part of COVID-19 surveillance efforts. Data are updated by health departments as additional information becomes available. This analysis includes cases reported during January 22–June 7 with data updated as of June 17, 2020. Included cases were limited to laboratory-confirmed infections with SARS-CoV-2 (confirmed by detection of SARS-CoV-2 RNA in a clinical specimen using a molecular amplification detection test) among women aged 15–44 years from 50 states, the District of Columbia, and New York City. Data collected included information on demographic characteristics, pregnancy status, underlying medical conditions, clinical signs and symptoms, and outcomes (including hospitalization, ICU admission, receipt of mechanical ventilation, and death). Outcomes with missing data were assumed not to have occurred (i.e., if data were missing on hospitalization, women were assumed to not have been hospitalized). Crude and adjusted risk ratios and 95% CIs for outcomes were calculated using modified Poisson regression. Risk ratios were adjusted for age (as a continuous variable), presence of underlying chronic conditions (yes/no), and race/ethnicity. All analyses were performed using SAS (version 9.4; SAS Institute). During January 22–June 7, among 1,573,211 laboratory-confirmed cases of SARS-CoV-2 infection reported to CDC as part of national COVID-19 surveillance, a total of 326,335 (20.7%) occurred among women aged 15–44 years. Data on pregnancy status were available for 91,412 (28.0%) of these women; 8,207 (9.0%) were pregnant (Table 1). Approximately one quarter of all women aged 15–44 years were aged 15–24 years. A total of 54.4% of pregnant women and 38.2% of nonpregnant women were aged 25–34 years; 22.1% of pregnant women and 38.3% of nonpregnant women were aged 35–44 years. Information on race/ethnicity was available for 80.4% of pregnant women and 70.6% of nonpregnant women. Among pregnant women, 46.2% were Hispanic, 23.0% were non-Hispanic white (white), 22.1% were non-Hispanic black (black), and 3.8% were non-Hispanic Asian compared with 38.1%, 29.4%, 25.4%, and 3.2%, respectively, among nonpregnant women. TABLE 1 Demographic characteristics, symptoms, and underlying medical conditions among women aged 15–44 years with known pregnancy status and laboratory-confirmed SARS-CoV-2 infection (N = 91,412),* by pregnancy status — United States, January 22–June 7, 2020 Characteristic No. (%) Pregnant women
(n = 8,207) Nonpregnant women
(n = 83,205) Age group (yrs) 15–24 1,921 (23.4) 19,557 (23.5) 25–34 4,469 (54.4) 31,818 (38.2) 35–44 1,817 (22.1) 31,830 (38.3) Race/Ethnicity† Hispanic or Latino 3,048 (46.2) 22,394 (38.1) Asian, non-Hispanic 254 (3.8) 1,869 (3.2) Black, non-Hispanic 1,459 (22.1) 14,922 (25.4) White, non-Hispanic 1,520 (23.0) 17,297 (29.4) Multiple or other race, non-Hispanic§ 321 (4.9) 2,299 (3.9) Symptom status¶ Symptomatic 5,199 (97.1) 72,549 (96.9) Asymptomatic 156 (2.9) 2,328 (3.1) Symptom reported** Cough 1,799 (51.8) 23,554 (53.7) Fever†† 1,190 (34.3) 18,474 (42.1) Muscle aches 1,323 (38.1) 20,693 (47.2) Chills 989 (28.5) 15,630 (35.6) Headache 1,409 (40.6) 22,899 (52.2) Shortness of breath 1,045 (30.1) 13,292 (30.3) Sore throat 942 (27.1) 13,681 (31.2) Diarrhea 497 (14.3) 10,113 (23.1) Nausea or vomiting 682 (19.6) 6,795 (15.5) Abdominal pain 350 (10.1) 5,139 (11.7) Runny nose 326 (9.4) 4,540 (10.4) New loss of taste or smell§§ 587 (16.9) 7,262 (16.6) Underlying medical condition Known underlying medical condition status¶¶ 1,878 (22.9) 29,142 (35.0) Diabetes mellitus 288 (15.3) 1,866 (6.4) Chronic lung disease 409 (21.8) 3,006 (10.3) Cardiovascular disease 262 (14.0) 2,082 (7.1) Chronic renal disease 12 (0.6) 266 (0.9) Chronic liver disease 8 (0.4) 141 (0.5) Immunocompromised condition 66 (3.5) 811 (2.8) Neurologic disorder, neurodevelopmental disorder, or intellectual disability 17 (0.9) 389 (1.3) Other chronic disease 162 (8.6) 1,586 (5.4) Abbreviation: COVID-19 = coronavirus disease 2019. * Women with known pregnancy status, representing 28% of 326,335 total cases in women aged 15–44 years. † Race/ethnicity was missing for 1,605 (20%) pregnant women and 24,424 (29%) nonpregnant women. § Other race includes American Indian or Alaska Native or Native Hawaiian or Other Pacific Islander. ¶ Data on symptom status were missing for 2,852 (35%) pregnant women and 8,328 (10%) nonpregnant women. ** Among symptomatic women (3,474 pregnant; 43,855 nonpregnant) with any of the following symptoms noted as present or absent on the CDC's Human Infection with 2019 Novel Coronavirus Case Report Form: fever (measured >100.4°F [38°C] or subjective), cough, shortness of breath, wheezing, difficulty breathing, chills, rigors, myalgia, rhinorrhea, sore throat, chest pain, nausea or vomiting, abdominal pain, headache, fatigue, diarrhea (three or more loose stools in a 24-hour period), new olfactory or taste disorder, or other symptom not otherwise specified on the form. †† Patients were included if they had information for either measured or subjective fever variables and were considered to have a fever if “yes” was indicated for either variable. §§ New olfactory and taste disorder has only been included on the CDC's Human Infection with 2019 Novel Coronavirus Case Report Form since May 5, 2020. Therefore, data might be underreported for this symptom. ¶¶ Status was classified as “known” if any of the following conditions were noted as present or absent on the CDC's Human Infection with 2019 Novel Coronavirus Case Report Form: diabetes mellitus, cardiovascular disease (including hypertension), severe obesity (body mass index ≥40 kg/m2), chronic renal disease, chronic liver disease, chronic lung disease, immunosuppressive condition, autoimmune condition, neurologic condition (including neurodevelopmental, intellectual, physical, visual, or hearing impairment), psychological/psychiatric condition, and other underlying medical condition not otherwise specified. Symptom status was reported for 65.2% of pregnant women and 90.0% of nonpregnant women; among those with symptom status reported, 97.1% of pregnant and 96.9% nonpregnant women reported being symptomatic. Symptomatic pregnant and nonpregnant women also reported similar frequencies of cough (51.8% versus 53.7%) and shortness of breath (30.1% versus 30.3%). Pregnant women less frequently reported headache (40.6% versus 52.2%), muscle aches (38.1% versus 47.2%), fever (34.3% versus 42.1%), chills (28.5% versus 35.6%), and diarrhea (14.3% versus 23.1%) than did nonpregnant women. Data were available on presence and absence of underlying chronic conditions for 22.9% of pregnant women and 35.0% of nonpregnant women. Chronic lung disease (21.8% pregnant; 10.3% nonpregnant), diabetes mellitus (15.3% pregnant; 6.4% nonpregnant), and cardiovascular disease (14.0% pregnant; 7.1% nonpregnant) were the most commonly reported chronic conditions. Data were not available to distinguish whether chronic conditions were present before or associated with pregnancy (e.g., gestational diabetes or hypertensive disorders of pregnancy). Hospitalization was reported by a substantially higher percentage of pregnant women (31.5%) than nonpregnant women (5.8%) (Table 2). Data were not available to distinguish hospitalization for COVID-19–related circumstances (e.g., worsening respiratory status) from hospital admission for pregnancy-related treatment or procedures (e.g., delivery). Pregnant women were admitted more frequently to the ICU (1.5%) than were nonpregnant women (0.9%). Similarly, 0.5% of pregnant women required mechanical ventilation compared with 0.3% of nonpregnant women. Sixteen deaths (0.2%) were reported among 8,207 pregnant women, and 208 (0.2%) were reported among 83,205 nonpregnant women. When stratified by age, all outcomes (hospitalization, ICU admission, receipt of mechanical ventilation, and death) were more frequently reported among women aged 35–44 years than among those aged 15–24 years, regardless of pregnancy status. When stratified by race/ethnicity, ICU admission was most frequently reported among pregnant women who were non-Hispanic Asian (3.5%) than among all pregnant women (1.5%) (Table 2). TABLE 2 Hospitalizations, intensive care unit (ICU) admissions, receipt of mechanical ventilation, and deaths among women with known pregnancy status and laboratory-confirmed SARS-CoV-2 infection (N = 91,412), by pregnancy status, age group, and race/ethnicity, and relative risk for these outcomes comparing pregnant women to nonpregnant women aged 15–44 years — United States, January 22–June 7, 2020 Outcome* No. (%) Crude risk ratio
(95% CI) Adjusted risk ratio†
(95% CI) Pregnant women
(n = 8,207) Nonpregnant women
(n = 83,205) Hospitalization§ 5.4 (5.2–5.7) 5.4 (5.1–5.6) All 2,587 (31.5) 4,840 (5.8) Age group (yrs) 15–24 562 (29.3) 639 (3.3) 25–34 1,398 (31.3) 1,689 (5.3) 35–44 627 (34.5) 2,512 (7.9) Race/Ethnicity¶ Hispanic or Latino 968 (31.7) 1,473 (6.5) Asian, non-Hispanic 100 (39.4) 136 (7.3) Black, non-Hispanic 461 (31.6) 1,199 (8.0) White, non-Hispanic 492 (32.4) 803 (4.6) Multiple or other race, non-Hispanic** 136 (42.4) 194 (8.4) ICU admission†† 1.6 (1.3–1.9) 1.5 (1.2–1.8) All 120 (1.5) 757 (0.9) Age group (yrs) 15–24 19 (1.0) 100 (0.5) 25–34 53 (1.2) 251 (0.8) 35–44 48 (2.6) 406 (1.3) Race/Ethnicity Hispanic or Latino 49 (1.6) 194 (0.9) Asian, non-Hispanic 9 (3.5) 25 (1.3) Black, non-Hispanic 28 (1.9) 194 (1.3) White, non-Hispanic 12 (0.8) 158 (0.9) Multiple or other race, non-Hispanic** <5 (—§§) 40 (1.7) Hispanic or Latino 49 (1.6) 194 (0.9) Mechanical ventilation¶¶ 1.9 (1.4–2.6) 1.7 (1.2–2.4) All 42 (0.5) 225 (0.3) Age group (yrs) 15–24 <5 (—§§) 22 (0.1) 25–34 18 (0.4) 74 (0.2) 35–44 21 (1.2) 129 (0.4) Race/Ethnicity Hispanic or Latino 13 (0.4) 70 (0.3) Asian, non-Hispanic <5 (—§§) 13 (0.7) Black, non-Hispanic 9 (0.6) 48 (0.3) White, non-Hispanic <5 (—§§) 44 (0.3) Multiple or other race, non-Hispanic** 5 (1.6) 16 (0.7) Death*** 0.8 (0.5–1.3) 0.9 (0.5–1.5) All 16 (0.2) 208 (0.2) Age group (yrs) 15–24 <5 (—§§) 9 (0.0) 25–34 7 (0.2) 58 (0.2) 35–44 8 (0.4) 141 (0.4) Race/Ethnicity Hispanic or Latino 5 (0.2) 47 (0.2) Asian, non-Hispanic <5 (—§§) 7 (0.4) Black, non-Hispanic 6 (0.4) 74 (0.5) White, non-Hispanic <5 (—§§) 37 (0.2) Multiple or other race, non-Hispanic** <5 (—§§) 8 (0.4) Abbreviations: CI = confidence interval; COVID-19 = coronavirus disease 2019. * Percentages calculated among total in pregnancy status group with known hospitalization status, ICU admission status, mechanical ventilation status, or death. † Adjusted for age as a continuous variable, dichotomous yes/no variable for presence of underlying conditions, and categorical race/ethnicity variable. Nonpregnant women are the referent group. § A total of 1,539 (18%) pregnant women and 9,744 (12%) nonpregnant women were missing information on hospitalization status and were assumed to have not been hospitalized. ¶ Race/ethnicity was missing for 1,605 (20%) pregnant women and 24,424 (29%) nonpregnant women. ** Other race includes American Indian or Alaska Native or Native Hawaiian or Other Pacific Islander. †† A total of 6,079 (74%) pregnant women and 58,888 (71%) nonpregnant women were missing information for ICU admission and were assumed to have not been admitted to an ICU. §§ Cell counts <5 are suppressed. ¶¶ A total of 6,351 (77%) pregnant women and 63,893 (77%) nonpregnant women were missing information for receipt of mechanical ventilation and were assumed to have not received mechanical ventilation. *** A total of 3,819 (47%) pregnant women and 17,420 (21%) nonpregnant women were missing information on death and were assumed to have survived. After adjusting for age, presence of underlying conditions, and race/ethnicity, pregnant women were 5.4 times more likely to be hospitalized (95% CI = 5.1–5.6), 1.5 times more likely to be admitted to the ICU ( 95% CI = 1.2–1.8), and 1.7 times more likely to receive mechanical ventilation (95% CI = 1.2–2.4) (Table 2). No difference in the risk for death between pregnant and nonpregnant women was found (aRR = 0.9, 95% CI = 0.5–1.5). Discussion As of June 7, 2020, a total of 8,207 cases of COVID-19 in pregnant women were reported to CDC, representing approximately 9% of cases among women of reproductive age with data available on pregnancy status. This finding is similar to that of a recent analysis of hospitalized COVID-19 patients ( 3 ); however, given that approximately 5% of women aged 15–44 years are pregnant at a point in time,** this percentage is higher than expected. Although these findings could be related to the increased risk for illness, they also could be related to the high proportion of reproductive-aged women for whom data on pregnancy status was missing, if these women were more likely to not be pregnant. The higher-than-expected percentage of COVID-19 cases among women of reproductive age who were pregnant might also be attributable to increased screening and detection of SARS-CoV-2 infection in pregnant women compared with nonpregnant women or by more frequent health care encounters, which increase opportunities to receive SARS-CoV-2 testing. Several inpatient obstetric health care facilities have implemented universal screening and testing policies for pregnant women upon admission ( 4 – 6 ). During the study period, among pregnant women with laboratory-confirmed SARS-CoV-2 infection who reported race/ethnicity, 46% were Hispanic, 22% were black, and 23% were white; these proportions differ from those among women with reported race/ethnicity who gave birth in 2019: 24% were Hispanic, 15% were black, and 51% were white. †† Although data on race/ethnicity were missing for 20% of pregnant women in this study, these findings suggest that pregnant women who are Hispanic and black might be disproportionately affected by SARS-CoV-2 infection during pregnancy. Among women with known symptom status, similar percentages of pregnant and nonpregnant women were symptomatic with COVID-19. However, data on symptom status were missing for approximately one third of pregnant women, compared with 10% of nonpregnant women; therefore, if those with missing symptom status are more likely to be asymptomatic, the percentage of pregnant women who are asymptomatic could be higher than the percentage of asymptomatic nonpregnant women. The percentages of pregnant women reporting fever, muscle aches, chills, headache, and diarrhea were lower than those reported among nonpregnant women, suggesting that signs and symptoms of COVID-19 might differ between pregnant and nonpregnant women. Diabetes mellitus, chronic lung disease, and cardiovascular disease were reported more frequently among pregnant women than among nonpregnant women. Additional information is needed to distinguish medical conditions that developed before pregnancy from those that developed during pregnancy and to determine whether this distinction affects clinical outcomes of COVID-19. Whereas hospitalization occurred in a significantly higher proportion of pregnant women than nonpregnant women, data needed to distinguish hospitalization for COVID-19 from hospital admission for pregnancy-related conditions were not available. Further, differences in hospitalization by pregnancy status might reflect a lower threshold for admitting pregnant patients or for universal screening and testing policies that some hospitals have implemented for women admitted to the labor and delivery unit ( 4 – 7 ). In contrast, however, ICU admission and receipt of mechanical ventilation are distinct proxies for illness severity ( 8 ), and after adjusting for age, presence of underlying conditions, and race/ethnicity, the risks for both outcomes were significantly higher among pregnant women than among nonpregnant women. These findings are similar to those from a recent study in Sweden, which found that pregnant women with COVID-19 were five times more likely to be admitted to the ICU and four times more like to receive mechanical ventilation than were nonpregnant women ( 9 ). The risk for death was the same for pregnant and nonpregnant women. A recent meta-analysis of individual participant data among women of reproductive age found that for influenza, pregnancy was associated with a seven times higher risk for hospitalization, a lower risk for ICU admission, and no increased risk for death ( 10 ). The findings in this report are subject to at least four limitations. First, pregnancy status was missing for three quarters of women of reproductive age with SARS-CoV-2 infection. Moreover, among COVID-19 cases in female patients with known pregnancy status, data on race/ethnicity, symptoms, underlying conditions, and outcomes were missing for a large proportion of cases. This circumstance could lead to overestimation or underestimation of some characteristics, if those with missing data were systematically different from those with available data. To avoid overestimating the risk for adverse outcomes, the absence of data on an outcome was assumed to indicate that the outcome did not occur, and those persons with missing information were included in the denominator. Second, additional time might be needed to ascertain and report outcomes such as ICU admission, mechanical ventilation, and death, and this analysis might underestimate the prevalence of these outcomes. Third, information on pregnancy trimester at the time of infection or whether the hospitalization was related to pregnancy conditions rather than for COVID-19 illness was not available and limits the interpretation of hospitalization data. Finally, routine case surveillance does not capture pregnancy or birth outcomes; thus, it remains unclear whether SARS-CoV-2 infection during pregnancy is associated with adverse pregnancy outcomes, such as pregnancy loss or preterm birth. The findings in this report suggest that among adolescents and women aged 15–44 years with COVID-19, pregnancy is associated with increased risk for ICU admission and receipt of mechanical ventilation, but it is not associated with increased risk for mortality. This report also highlights the need for more complete data to fully understand the risk for severe illness resulting from SARS-CoV-2 infection in pregnant women. Further, collection of longitudinal data for pregnant women with SARS-CoV-2 infection, including information about pregnancy outcomes, is needed to understand the effects of SARS-CoV-2 infection on maternal and neonatal outcomes. To address these data gaps, CDC, in collaboration with health departments, has initiated COVID-19 pregnancy surveillance to report pregnancy-related information and outcomes among pregnant women with laboratory-confirmed SARS-CoV-2 infection. CDC will continue to provide updates on COVID-19 cases in pregnant women. Although additional data are needed to further understand these observed elevated risks, pregnant women should be made aware of their potential risk for severe illness from COVID-19. Pregnant women and their families should take measures to ensure their health and prevent the spread of SARS-CoV-2 infection. Specific actions pregnant women can take include not skipping prenatal care appointments, limiting interactions with other people as much as possible, taking precautions to prevent getting COVID-19 when interacting with others, having at least a 30-day supply of medicines, and talking to their health care provider about how to stay healthy during the COVID-19 pandemic. §§ To reduce severe outcomes from COVID-19 among pregnant women, measures to prevent SARS-CoV-2 infection should be emphasized, and potential barriers to the ability to adhere to these measures need to be addressed. Summary What is already known about this topic? Limited information is available about SARS-CoV-2 infection in U.S. pregnant women. What is added by this report? Hispanic and non-Hispanic black pregnant women appear to be disproportionately affected by SARS-CoV-2 infection during pregnancy. Among reproductive-age women with SARS-CoV-2 infection, pregnancy was associated with hospitalization and increased risk for intensive care unit admission, and receipt of mechanical ventilation, but not with death. What are the implications for public health practice? Pregnant women might be at increased risk for severe COVID-19 illness. To reduce severe COVID-19–associated illness, pregnant women should be aware of their potential risk for severe COVID-19 illness. Prevention of COVID-19 should be emphasized for pregnant women and potential barriers to adherence to these measures need to be addressed.
- Record: found
- Abstract: found
- Article: not found
Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group.
Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.
Author and article information
Contributors
Carrie Bennett: bennetc4@ccf.org
Journal
Journal ID (nlm-ta): J Obstet Gynaecol Res
Journal ID (iso-abbrev): J Obstet Gynaecol Res
Journal ID (doi): 10.1111/(ISSN)1447-0756
Journal ID (publisher-id): JOG
Title:
The Journal of Obstetrics and Gynaecology Research
Publisher:
John Wiley & Sons Australia, Ltd
(Kyoto, Japan
)
ISSN
(Print):
1341-8076
ISSN
(Electronic):
1447-0756
Publication date
(Electronic):
22
August
2021
Publication date
(Print):
November
2021
Publication date PMC-release: 22
August
2021
Volume: 47
Issue: 11
(
doiID:
10.1111/jog.v47.11
)
Pages: 4077-4080
Affiliations
Author notes
[*]
[*
]
Correspondence: Carrie Bennett, Department of Obstetrics and Gynecology, Women's Health Institute,
Cleveland Clinic, Desk A81, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
Email: bennetc4@ 123456ccf.org
Email: bennetc4@ 123456ccf.org
Article
Publisher ID: JOG14978DOI: 10.1111/jog.14978
PMC ID: 8661984
PubMed ID: 34420249
SO-VID: 09ed39a2-9221-44a9-b708-3826a795e7ac
Copyright © © 2021 Japan Society of Obstetrics and Gynecology.
License:
This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.
History
Date
revision received
: 23
July
2021
Date
received
: 01
March
2021
Date
accepted
: 29
July
2021
Page count
Figures: 2,
Tables: 0,
Pages: 4,
Words: 2063
Categories
Subject:
Case Report
Subject:
Case Reports
Custom metadata
source-schema-version-number 2.0
cover-date November 2021
details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.9 mode:remove_FC converted:10.12.2021
Data availability: