Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-30 (of 39 Records) |
Query Trace: Simeone RM [original query] |
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Durability of original monovalent mRNA vaccine effectiveness against COVID-19 Omicron-associated hospitalization in children and adolescents - United States, 2021-2023
Zambrano LD , Newhams MM , Simeone RM , Payne AB , Wu M , Orzel-Lockwood AO , Halasa NB , Calixte JM , Pannaraj PS , Mongkolrattanothai K , Boom JA , Sahni LC , Kamidani S , Chiotos K , Cameron MA , Maddux AB , Irby K , Schuster JE , Mack EH , Biggs A , Coates BM , Michelson KN , Bline KE , Nofziger RA , Crandall H , Hobbs CV , Gertz SJ , Heidemann SM , Bradford TT , Walker TC , Schwartz SP , Staat MA , Bhumbra SS , Hume JR , Kong M , Stockwell MS , Connors TJ , Cullimore ML , Flori HR , Levy ER , Cvijanovich NZ , Zinter MS , Maamari M , Bowens C , Zerr DM , Guzman-Cottrill JA , Gonzalez I , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2024 73 (15) 330-338 Pediatric COVID-19 vaccination is effective in preventing COVID-19-related hospitalization, but duration of protection of the original monovalent vaccine during SARS-CoV-2 Omicron predominance merits evaluation, particularly given low coverage with updated COVID-19 vaccines. During December 19, 2021-October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ≥2 original monovalent COVID-19 mRNA vaccine doses against COVID-19-related hospitalization and critical illness among U.S. children and adolescents aged 5-18 years, using a case-control design. Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness. Most case-patients (persons with a positive SARS-CoV-2 test result) were unvaccinated, despite the high frequency of reported underlying conditions associated with severe COVID-19. VE of the original monovalent vaccine against COVID-19-related hospitalizations was 52% (95% CI = 33%-66%) when the most recent dose was administered <120 days before hospitalization and 19% (95% CI = 2%-32%) if the interval was 120-364 days. VE of the original monovalent vaccine against COVID-19-related hospitalization was 31% (95% CI = 18%-43%) if the last dose was received any time within the previous year. VE against critical COVID-19-related illness, defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death, was 57% (95% CI = 21%-76%) when the most recent dose was received <120 days before hospitalization, 25% (95% CI = -9% to 49%) if it was received 120-364 days before hospitalization, and 38% (95% CI = 15%-55%) if the last dose was received any time within the previous year. VE was similar after excluding children and adolescents with documented immunocompromising conditions. Because of the low frequency of children who received updated COVID-19 vaccines and waning effectiveness of original monovalent doses, these data support CDC recommendations that all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19. |
Notes from the field: Surveillance for multisystem inflammatory syndrome in children - United States, 2023
Yousaf AR , Lindsey KN , Wu MJ , Shah AB , Free RJ , Simeone RM , Zambrano LD , Campbell AP . MMWR Morb Mortal Wkly Rep 2024 73 (10) 225-228 |
Characteristics and clinical outcomes of vaccine-eligible US children under-5 years hospitalized for acute COVID-19 in a national network
Zambrano LD , Newhams MM , Simeone RM , Fleming-Dutra KE , Halasa N , Wu M , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Chiotos K , Cameron MA , Maddux AB , Schuster JE , Crandall H , Kong M , Nofziger RA , Staat MA , Bhumbra SS , Irby K , Boom JA , Sahni LC , Hume JR , Gertz SJ , Maamari M , Bowens C , Levy ER , Bradford TT , Walker TC , Schwartz SP , Mack EH , Guzman-Cottrill JA , Hobbs CV , Zinter MS , Cvijanovich NZ , Bline KE , Hymes SR , Campbell AP , Randolph AG . Pediatr Infect Dis J 2023 BACKGROUND AND OBJECTIVES: In June 2022, the mRNA COVID-19 vaccination was recommended for young children. We examined clinical characteristics and factors associated with vaccination status among vaccine-eligible young children hospitalized for acute COVID-19. METHODS: We enrolled inpatients aged 8 months to <5 years with acute community-acquired COVID-19 across 28 US pediatric hospitals from September 20, 2022 to May 31, 2023. We assessed demographic and clinical factors, including the highest level of respiratory support, and vaccination status defined as unvaccinated, incomplete, or complete primary series [at least 2 (Moderna) or 3 (Pfizer-BioNTech) mRNA vaccine doses ≥14 days before hospitalization]. RESULTS: Among 597 children, 174 (29.1%) patients were admitted to the intensive care unit and 75 (12.6%) had a life-threatening illness, including 51 (8.5%) requiring invasive mechanical ventilation. Children with underlying respiratory and neurologic/neuromuscular conditions more frequently received higher respiratory support. Only 4.5% of children hospitalized for COVID-19 (n = 27) had completed their primary COVID-19 vaccination series and 7.0% (n = 42) of children initiated but did not complete their primary series. Among 528 unvaccinated children, nearly half (n = 251) were previously healthy, 3 of them required extracorporeal membrane oxygenation for acute COVID-19 and 1 died. CONCLUSIONS: Most young children hospitalized for acute COVID-19, including most children admitted to the intensive care unit and with life-threatening illness, had not initiated COVID-19 vaccination despite being eligible. Nearly half of these children had no underlying conditions. Of the small percentage of children who initiated a COVID-19 primary series, most had not completed it before hospitalization. |
CDC Division of Reproductive Health's emergency preparedness resources and activities for radiation emergencies: Public health considerations for women's reproductive health
Riser A , Perez M , Snead MC , Galang RR , Simeone RM , Salame-Alfie A , Rice ME , Sayyad A , Strid P , Yocca J , Meeker JR , Waits G , Hansen S , Hall R , Anstey E , House LD , Okoroh E , Zotti M , Ellington SR . J Womens Health (Larchmt) 2023 32 (12) 1271-1280 Pregnant, postpartum, and lactating people, and infants have unique needs during public health emergencies, including nuclear and radiological incidents. This report provides information on the CDC Division of Reproductive Health's emergency preparedness and response activities to address the needs of women of reproductive age (aged 15-49 years), people who are pregnant, postpartum, or lactating, and infants during a radiation emergency. Highlighted preparedness activities include: (1) development of a quick reference guide to inform key questions about pregnant, postpartum, and lactating people, and infants during radiation emergencies; and (2) exercising the role of reproductive health experts during nuclear and radiological incident preparedness activities. |
Pre-Delta, Delta, and Omicron periods of the coronavirus disease 2019 (COVID-19) pandemic and health outcomes during delivery hospitalization
Carlson J , Simeone RM , Ellington S , Galang R , DeSisto CL , Fleming-Dutra K , Riley L , Meaney-Delman D , Tong VT . Obstet Gynecol 2023 143 (1) 131-138 OBJECTIVE: To examine the relationship between coronavirus disease 2019 (COVID-19) diagnosis at delivery and adverse maternal health and pregnancy outcomes during pre-Delta, Delta, and Omicron variant predominance, with a focus on the time period of Omicron variant predominance. METHODS: We conducted a cross-sectional observational study with data from delivery hospitalizations in the Premier Healthcare Database from February 2020 to August 2023. The pre-Delta (February 2020-June 2021), Delta (July 2021-December 2021), and Omicron (January 2022-August 2023) periods of variant predominance were examined. Exposure to COVID-19 was identified by having a diagnostic code for COVID-19 during the delivery hospitalization. Adjusted prevalence ratios (aPRs) were calculated to compare the risks of adverse maternal and pregnancy outcomes for women with and without COVID-19 diagnoses at the time of delivery for each variant period. RESULTS: Among 2,990,973 women with delivery hospitalizations, 1.9% (n=56,618) had COVID-19 diagnoses noted at delivery admission discharge, including 26,053 during the Omicron period. Across all variant time periods, the prevalence of many adverse maternal and pregnancy outcomes during the delivery hospitalization was significantly higher for pregnant women with COVID-19 compared with pregnant women without COVID-19. In adjusted models, COVID-19 during the Omicron period was associated with significant increased risks for maternal sepsis (COVID-19: 0.4% vs no COVID-19: 0.1%; aPR 3.32, 95% CI, 2.70-4.08), acute respiratory distress syndrome (0.6% vs 0.1%; aPR 6.19, 95% CI, 5.26-7.29), shock (0.2% vs 0.1%; aPR 2.14, 95% CI, 1.62-2.84), renal failure (0.5% vs 0.2%; aPR 2.08, 95% CI, 1.73-2.49), intensive care unit admission (2.7% vs 1.7%; aPR 1.64, 95% CI, 1.52-1.77), mechanical ventilation (0.3% vs 0.1%; aPR 3.15, 95% CI, 2.52-3.93), in-hospital death (0.03% vs 0.01%; aPR 5.00, 95% CI, 2.30-10.90), stillbirth (0.7% vs 0.6%; aPR 1.17, 95% CI, 1.01-1.36), and preterm delivery (12.3% vs 9.6%; aPR 1.28, 95% CI, 1.24-1.33). CONCLUSION: Despite the possibility of some level of immunity due to previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, vaccination, or testing differences, risks of adverse outcomes associated with COVID-19 diagnosis at delivery remained elevated during the Omicron variant time period. |
Effectiveness of maternal mRNA COVID-19 vaccination during pregnancy against COVID-19-associated hospitalizations in infants aged <6 months during SARS-cov-2 Omicron predominance - 20 states, March 9, 2022-May 31, 2023
Simeone RM , Zambrano LD , Halasa NB , Fleming-Dutra KE , Newhams MM , Wu MJ , Orzel-Lockwood AO , Kamidani S , Pannaraj PS , Irby K , Maddux AB , Hobbs CV , Cameron MA , Boom JA , Sahni LC , Kong M , Nofziger RA , Schuster JE , Crandall H , Hume JR , Staat MA , Mack EH , Bradford TT , Heidemann SM , Levy ER , Gertz SJ , Bhumbra SS , Walker TC , Bline KE , Michelson KN , Zinter MS , Flori HR , Campbell AP , Randolph AG . MMWR Morb Mortal Wkly Rep 2023 72 (39) 1057-1064 Infants aged <6 months are not eligible for COVID-19 vaccination. Vaccination during pregnancy has been associated with protection against infant COVID-19-related hospitalization. The Overcoming COVID-19 Network conducted a case-control study during March 9, 2022-May 31, 2023, to evaluate the effectiveness of maternal receipt of a COVID-19 vaccine dose (vaccine effectiveness [VE]) during pregnancy against COVID-19-related hospitalization in infants aged <6 months and a subset of infants aged <3 months. VE was calculated as (1 - adjusted odds ratio) x 100% among all infants aged <6 months and <3 months. Case-patients (infants hospitalized for COVID-19 outside of birth hospitalization and who had a positive SARS-CoV-2 test result) and control patients (infants hospitalized for COVID-19-like illness with a negative SARS-CoV-2 test result) were compared. Odds ratios were determined using multivariable logistic regression, comparing the odds of receipt of a maternal COVID-19 vaccine dose (completion of a 2-dose vaccination series or a third or higher dose) during pregnancy with maternal nonvaccination between case- and control patients. VE of maternal vaccination during pregnancy against COVID-19-related hospitalization was 35% (95% CI = 15%-51%) among infants aged <6 months and 54% (95% CI = 32%-68%) among infants aged <3 months. Intensive care unit admissions occurred in 23% of all case-patients, and invasive mechanical ventilation was more common among infants of unvaccinated (9%) compared with vaccinated mothers (1%) (p = 0.02). Maternal vaccination during pregnancy provides some protection against COVID-19-related hospitalizations among infants, particularly those aged <3 months. Expectant mothers should remain current with COVID-19 vaccination to protect themselves and their infants from hospitalization and severe outcomes associated with COVID-19. |
Differences in delivery hospitalization experiences during the COVID-19 pandemic by maternal race and ethnicity, Pregnancy Risk Assessment Monitoring System, 2020
Simeone RM , Meghani M , Meeker JR , Zapata LB , Galang RR , Salvesen Von Essen B , Dieke A , Ellington SR . J Perinatol 2023 OBJECTIVE: We investigated maternal COVID-19 related experiences during delivery hospitalizations, and whether experiences differed by maternal race and ethnicity. STUDY DESIGN: Data from the Pregnancy Risk Assessment Monitoring System among women with live births between April-December 2020 were used. Adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) estimated associations between maternal race and ethnicity and COVID-19 related delivery experiences. RESULTS: Among 12,879 women, 3.6% reported infant separation and 1.8% reported not being allowed support persons. Compared with non-Hispanic White women, American Indian/Alaska Native (AI/AN) (aPR = 2.7; CI: 1.2-6.2), Hispanic (aPR = 2.2; CI: 1.5-3.1), non-Hispanic Black (aPR = 2.4; CI: 1.7-3.6), and non-Hispanic Asian (aPR = 2.8; CI: 1.6-4.9) women reported more infant separation due to COVID-19. Not being allowed support persons was more common among AI/AN (aPR = 5.2; CI: 1.8-14.8) and non-Hispanic Black (aPR = 2.3; CI: 1.3-4.1) women. CONCLUSIONS: COVID-19 related delivery hospitalization experiences were unequally distributed among racial and ethnic minorities. |
Influenza and tetanus, diphtheria, and acellular pertussis vaccination coverage during pregnancy: Pregnancy Risk Assessment Monitoring System, 2020
Kortsmit K , Oduyebo T , Simeone RM , Kahn KE , Razzaghi H , Galang RR , Ellington S , Ruffo N , Barfield WD , Warner L , Cox S . Public Health Rep 2023 333549231179252 OBJECTIVES: Estimates of vaccination coverage during pregnancy and identification of disparities in vaccination coverage can inform vaccination campaigns and programs. We reported the prevalence of being offered or told to get the influenza vaccine by a health care provider (hereinafter, provider); influenza vaccination coverage during the 12 months before delivery; and tetanus, diphtheria, and acellular pertussis (Tdap) vaccination coverage during pregnancy among women with a recent live birth in the United States. METHODS: We analyzed 2020 data from the Pregnancy Risk Assessment Monitoring System from 42 US jurisdictions (n = 41 673). We estimated the overall prevalence of being offered or told to get the influenza vaccine by a provider and influenza vaccination coverage during the 12 months before delivery. We estimated Tdap vaccination coverage during pregnancy from 21 jurisdictions with available data (n = 22 020) by jurisdiction and select characteristics. RESULTS: In 2020, 84.9% of women reported being offered or told to get the influenza vaccine, and 60.9% received it, ranging from 35.0% in Puerto Rico to 79.7% in Massachusetts. Influenza vaccination coverage was lower among women who were not offered or told to get the influenza vaccine (21.4%) than among women who were offered or told to get the vaccine (68.1%). Overall, 72.7% of women received the Tdap vaccine, ranging from 52.8% in Mississippi to 86.7% in New Hampshire. Influenza and Tdap vaccination coverage varied by all characteristics examined. CONCLUSIONS: These results can inform vaccination programs and strategies to address disparities in vaccination coverage during pregnancy and may inform vaccination efforts for other infectious diseases among pregnant women. |
Pregnant women's experiences during and after hurricanes Irma and Maria, pregnancy risk assessment monitoring system, Puerto Rico, 2018
Simeone RM , House LD , Salvesen von Essen B , Kortsmit K , Hernandez Virella W , Vargas Bernal MI , Galang RR , D'Angelo DV , Shapiro-Mendoza CK , Ellington SR . Public Health Rep 2023 138 (6) 333549221142571 OBJECTIVE: Exposure to natural disasters during and after pregnancy may increase adverse mental health outcomes. Hurricanes Irma and Maria struck Puerto Rico in September 2017. Our objectives were to understand hurricane-related experiences, maternal health concerns, and the impact of hurricane experiences on postpartum depressive symptoms (PDS). METHODS: We used data from the 2018 Pregnancy Risk Assessment Monitoring System to describe differences in maternal hurricane experiences among women who were pregnant during and after the 2017 hurricanes. We assessed maternal concerns and PDS. We estimated adjusted prevalence ratios (aPRs) and 95% CIs for the associations between hurricane experiences and PDS. RESULTS: The most frequently reported hurricane experiences were losing power for ≥1 week (97%) and feeling unsafe due to lack of order/security (70%). Almost 30% of women who were pregnant during the hurricanes reported missing prenatal care. PDS were reported by 13% of women. Most hurricane experiences were associated with an increased prevalence of PDS. Feeling unsafe (aPR = 2.4; 95% CI, 1.2-4.9) and having difficulty getting food (aPR = 2.1; 95% CI, 1.1-4.1) had the strongest associations. CONCLUSIONS: Most women who were pregnant during or after hurricanes Irma and Maria struck Puerto Rico reported negative hurricane experiences, and most experiences were associated with an increased prevalence of PDS. Understanding the experiences of pregnant women during and after disasters and identifying risks for adverse mental health outcomes after pregnancy are important to inform emergency preparedness and prenatal and postpartum care. |
Delayed entry into prenatal care among women with pre-pregnancy health conditions, National Birth Defects Prevention Study, 1997-2011
Simeone RM , Reefhuis J , Jamieson DJ , Drews-Botsch CD , Lash TL , Fisher SC , Howley MM , Evans S , Howards PP . Prev Med 2022 164 107272 First trimester entry into prenatal care is recommended for all women, and especially women with pre-pregnancy conditions. Our objective was to determine whether women with pre-pregnancy conditions were at lower risk of entry after the first trimester (delayed entry) into prenatal care than women without a pre-pregnancy health condition. We used data from 10,890 participants in the National Birth Defects Prevention Study who delivered liveborn infants without birth defects. Women reported pre-pregnancy conditions and timing of entry into prenatal care during a computer-assisted telephone interview. Multivariable logistic regression analyses were conducted to evaluate whether having a pre-pregnancy condition was associated with delayed entry into prenatal care compared to women without pre-pregnancy conditions. Approximately 13% of women reported delayed entry into prenatal care, and 18% of women reported a pre-pregnancy condition. Delayed entry into prenatal care was not associated with pre-pregnancy cardiometabolic or neurologic conditions. Women with thyroid conditions were less likely to report delayed entry into prenatal care (prevalence odds ratio (OR), 95% confidence interval (CI): 0.55 [0.32, 0.94]), but women with hematologic and respiratory conditions were more likely to report delayed entry into prenatal care (OR: 1.95 [1.00, 3.82] and 1.27 [0.95, 1.72], respectively), compared to those without any chronic conditions. Future research investigating the success of early prenatal care among women with thyroid conditions could identify ways to reduce delayed prenatal care among women with other pre-pregnancy conditions. |
Critical Illness Among Patients Hospitalized With Acute COVID-19 With and Without Congenital Heart Defects.
Downing KF , Simeone RM , Oster ME , Farr SL . Circulation 2022 145 (15) 1182-1184 Given the increased risk for severe COVID-19 illness in individuals with cardiac disease, individuals with congenital heart defects (CHDs) might have increased risk of severe illness from COVID-19 as well.1 Most publications on CHD and COVID-19 illness have been restricted to patients at congenital cardiology centers, limiting generalizability, because many individuals with CHD do not receive specialized cardiology care.24 Furthermore, the studies did not include comparison groups without CHD or adjust for differences in established risk factors for critical COVID-19,4 and comparisons to general population estimates may be confounded. | | We compared the period prevalence of critical COVID-19 illness (intensive care unit [ICU] admission, invasive mechanical ventilation [IMV], or death) among hospitalized patients with COVID-19 with and without CHD. Among patients with CHD, we examined characteristics associated with critical COVID-19 illness. |
Changes in rates of adverse pregnancy outcomes during the COVID-19 pandemic: a cross-sectional study in the United States, 2019-2020.
Simeone RM , Downing KF , Wallace B , Galang RR , DeSisto CL , Tong VT , Zapata LB , Ko JY , Ellington SR . J Perinatol 2022 42 (5) 617-623 OBJECTIVE: Our objective was to assess differences inpregnancy outcomes during the COVID-19 pandemic compared to the previous year. STUDY DESIGN: In a cross-sectional study of delivery hospitalizations in the Premier Healthcare Database Special COVID-19 Release, we assessed differences in selected maternal and pregnancy outcomes occurring April-December in 2019 and 2020 in the United States. RESULT: Among 663,620 deliveries occurring in 2019 and 614,093 deliveries occurring in 2020, we observed an increase in in-hospital maternal death from 2019 to 2020, which was no longer statistically significant after excluding deliveries with a COVID-19 diagnosis. Intensive care unit admission and preterm birth decreased from 2019 to 2020. There was no difference in the prevalence of most other outcomes examined. CONCLUSION: The full impact of the COVID-19 pandemic on maternal and pregnancy outcomes remains to be understood. Most outcomes investigated experienced minimal change from 2019 to 2020. |
Post-traumatic stress disorder, anxiety, and depression among adults with congenital heart defects
Simeone RM , Downing KF , Bobo WV , Grosse SD , Khanna AD , Farr SL . Birth Defects Res 2021 114 124-135 BACKGROUND: Due to invasive treatments and stressors related to heart health, adults with congenital heart defects (CHDs) may have an increased risk of post-traumatic stress disorder (PTSD), anxiety, and/or depressive disorders. Our objectives were to estimate the prevalence of these disorders among individuals with CHDs. METHODS: Using IBM® MarketScan® Databases, we identified adults age 18-49 years with ≥2 outpatient anxiety/depressive disorder claims on separate dates or ≥1 inpatient anxiety/depressive disorder claim in 2017. CHDs were defined as ≥2 outpatient CHD claims ≥30 days apart or ≥1 inpatient CHD claim documented in 2007-2017. We used log-binomial regression to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for associations between CHDs and anxiety/depressive disorders. RESULTS: Of 13,807 adults with CHDs, 12.4% were diagnosed with an anxiety or depressive disorder. Adults with CHDs, compared to the 5,408,094 without CHDs, had higher prevalence of PTSD (0.8% vs. 0.5%; aPR: 1.5 [CI: 1.2-1.8]), anxiety disorders (9.9% vs. 7.5%; aPR: 1.3 [CI: 1.3-1.4]), and depressive disorders (6.3% vs. 4.9%; aPR: 1.3 [CI: 1.2-1.4]). Among individuals with CHDs, female sex (aPR range: 1.6-3.3) and inpatient admission (aPR range 1.1-1.9) were associated with anxiety/depressive disorders. CONCLUSION: Over 1 in 8 adults with CHDs had diagnosed PTSD and/or other anxiety/depressive disorders, 30-50% higher than adults without CHDs. PTSD was rare, but three times more common in women with CHDs than men. Screening and referral for services for these conditions in people with CHDs may be beneficial. |
Risk for Stillbirth Among Women With and Without COVID-19 at Delivery Hospitalization - United States, March 2020-September 2021.
DeSisto CL , Wallace B , Simeone RM , Polen K , Ko JY , Meaney-Delman D , Ellington SR . MMWR Morb Mortal Wkly Rep 2021 70 (47) 1640-1645 Pregnant women are at increased risk for severe COVID-19-related illness, and COVID-19 is associated with an increased risk for adverse pregnancy outcomes and maternal and neonatal complications (1-3). To date, studies assessing whether COVID-19 during pregnancy is associated with increased risk for stillbirth have yielded mixed results (2-4). Since the B.1.617.2 (Delta) variant of SARS-CoV-2 (the virus that causes COVID-19) became the predominant circulating variant,* there have been anecdotal reports of increasing rates of stillbirths in women with COVID-19.(†) CDC used the Premier Healthcare Database Special COVID-19 Release (PHD-SR), a large hospital-based administrative database,(§) to assess whether a maternal COVID-19 diagnosis documented at delivery hospitalization was associated with stillbirth during March 2020-September 2021 as well as before and during the period of Delta variant predominance in the United States (March 2020-June 2021 and July-September 2021, respectively). Among 1,249,634 deliveries during March 2020-September 2021, stillbirths were rare (8,154; 0.65%): 273 (1.26%) occurred among 21,653 deliveries to women with COVID-19 documented at the delivery hospitalization, and 7,881 (0.64%) occurred among 1,227,981 deliveries without COVID-19. The adjusted risk for stillbirth was higher in deliveries with COVID-19 compared with deliveries without COVID-19 during March 2020-September 2021 (adjusted relative risk [aRR] = 1.90; 95% CI = 1.69-2.15), including during the pre-Delta (aRR = 1.47; 95% CI = 1.27-1.71) and Delta periods (aRR = 4.04; 95% CI = 3.28-4.97). COVID-19 documented at delivery was associated with increased risk for stillbirth, with a stronger association during the period of Delta variant predominance. Implementing evidence-based COVID-19 prevention strategies, including vaccination before or during pregnancy, is critical to reducing the impact of COVID-19 on stillbirths. |
Evaluating Differences in Whole Blood, Serum, and Urine Screening Tests for Zika Virus, Puerto Rico, USA, 2016
Rosinger AY , Olson SM , Ellington SR , Perez-Padilla J , Simeone RM , Pedati CS , Schroeder BA , Santiago GA , Medina FA , Muñoz-Jordán JL , Adams LE , Galang RR , Valencia-Prado M , Bakkour S , Colón C , Goodwin M , Meaney-Delman D , Read JS , Petersen LR , Jamieson DJ , Deseda CC , Honein MA , Rivera-García B , Shapiro-Mendoza CK . Emerg Infect Dis 2021 27 (5) 1505-1508 We evaluated nucleic acid amplification testing (NAAT) for Zika virus on whole-blood specimens compared with NAAT on serum and urine specimens among asymptomatic pregnant women during the 2015-2016 Puerto Rico Zika outbreak. Using NAAT, more infections were detected in serum and urine than in whole blood specimens. |
Adverse pregnancy outcomes, maternal complications, and severe illness among U.S. delivery hospitalizations with and without a COVID-19 diagnosis.
Ko JY , DeSisto CL , Simeone RM , Ellington S , Galang RR , Oduyebo T , Gilboa SM , Lavery AM , Gundlapalli AV , Shapiro-Mendoza CK . Clin Infect Dis 2021 73 S24-S31 BACKGROUND: Evidence on risk for adverse outcomes from COVID-19 among pregnant women is still emerging. We examined the association between COVID-19 at delivery and adverse pregnancy outcomes, maternal complications, and severe illness, whether these associations differ by race/ethnicity; and described discharge status by COVID-19 diagnosis and maternal complications. METHODS: Data from 703 hospitals in the Premier Healthcare Database during March-September 2020 were included. Adjusted risk ratios overall and stratified by race/ethnicity were estimated using Poisson regression with robust standard errors. Proportion not discharged home was calculated by maternal complications, stratified by COVID-19 diagnosis. RESULTS: Among 489,471 delivery hospitalizations, 6,550 (1.3%) had a COVID-19 diagnosis. In adjusted models, COVID-19 was associated with increased risk for: acute respiratory distress syndrome (adjusted risk ratio [aRR] = 34.4), death (aRR = 17.0), sepsis (aRR = 13.6), mechanical ventilation (aRR = 12.7), shock (aRR = 5.1), intensive care unit admission (aRR = 3.6), acute renal failure (aRR = 3.5), thromboembolic disease (aRR = 2.7), adverse cardiac event/outcome (aRR = 2.2) and preterm labor with preterm delivery (aRR = 1.2). Risk for any maternal complications or for any severe illness did not significantly differ by race/ethnicity. Discharge status did not differ by COVID-19; however, among women with concurrent maternal complications, a greater proportion of those with (versus without) COVID-19 were not discharged home. CONCLUSIONS: These findings emphasize the importance of implementing recommended mitigation strategies to reduce risk for SARS-CoV-2 infection and further inform counseling and clinical care for pregnant women during the COVID-19 pandemic. |
Zika Prevention Behaviors Among Women of Reproductive Age in Puerto Rico, 2016
Ellington SR , Simeone RM , Serrano-Rodriguez RA , Bertolli J , Swartzendruber A , Goldberg HI , Mercado AS , Jamieson DJ , Honein MA , Cordero JF , Shapiro-Mendoza CK . Am J Prev Med 2021 61 (3) e149-e155 INTRODUCTION: Zika virus is primarily transmitted through mosquito bites. Because Zika virus infection during pregnancy can cause serious birth defects, reproductive-aged women need protection from Zika virus infection. This report describes Zika virus prevention behaviors among women aged 18-49 years and assesses whether pregnancy status and healthcare provider counseling increases Zika virus prevention behaviors. METHODS: A population-based cell phone survey of women aged 18-49 years living in Puerto Rico was conducted in July-November 2016. Data were analyzed in 2018-2019. Prevalence estimates and 95% CIs were calculated for Zika virus prevention behaviors. Adjusted prevalence ratios were estimated to examine the association of pregnancy status with healthcare provider counseling on Zika virus prevention behaviors, controlling for age, education, and health insurance status. RESULTS: Most women reported using screens on open doors/windows (87.7%) and eliminating standing water in/around their homes (92.3%). Other Zika virus prevention behaviors were less common (<33%). In adjusted analysis, pregnant women were more likely than women not at risk for unintended pregnancy to report using mosquito repellent every/most days (adjusted prevalence ratio=1.44, 95% CI=1.13, 1.85). Healthcare provider counseling was associated with receiving professional spraying/larvicide treatment (adjusted prevalence ratio=1.42, 95% CI=1.17, 1.74), sleeping under a bed net (adjusted prevalence ratio=2.37, 95% CI=1.33, 4.24), using mosquito repellent (adjusted prevalence ratio=1.57, 95% CI=1.40, 1.77), and wearing long sleeves/pants (adjusted prevalence ratio=1.32, 95% CI=1.12, 1.55). CONCLUSIONS: Receipt of healthcare provider counseling was more consistently associated with Zika virus prevention behaviors than pregnancy status. Healthcare provider counseling is an important strategy for increasing the uptake of Zika virus prevention behaviors among women aged 18-49 years. |
Modification of the association between diabetes and birth defects by obesity, National Birth Defects Prevention Study, 1997-2011
Tinker SC , Gilboa SM , Moore CA , Waller DK , Simeone RM , Kim SY , Jamieson DJ , Botto LD , Fisher SC , Reefhuis J . Birth Defects Res 2021 113 (14) 1084-1097 BACKGROUND: Maternal pregestational diabetes and obesity are risk factors for birth defects. Diabetes and obesity often occur together; it is unclear whether their co-occurrence compounds birth defect risk. METHODS: We analyzed 1997-2011 data on 29,671 cases and 10,963 controls from the National Birth Defects Prevention Study, a multisite case-control study. Mothers self-reported height, pregestational weight, and diabetes (pregestational and gestational; analyzed separately). We created four exposure groups: no obesity or diabetes (referent), obesity only, diabetes only, and both obesity and diabetes. We estimated odds ratios (ORs) using logistic regression and the relative excess risk due to interaction (RERI). RESULTS: Among mothers with pregestational obesity without diabetes, modest associations (OR range: 1.1-1.5) were observed for neural tube defects, small intestinal atresia, anorectal atresia, renal agenesis/hypoplasia, omphalocele, and several congenital heart defects. Pregestational diabetes, regardless of obesity, was strongly associated with most birth defects (OR range: 2.0-75.9). Gestational diabetes and obesity had a stronger association than for obesity alone and the RERI (in parentheses) suggested additive interaction for hydrocephaly (1.2; 95% confidence interval [CI]: -0.1, 2.5), tetralogy of Fallot (0.9; 95% CI: -0.01, 1.8), atrioventricular septal defect (1.1; 95% CI: -0.1, 2.3), hypoplastic left heart syndrome (1.1; 95% CI: -0.2, 2.4), and atrial septal defect secundum or not otherwise specified (1.0; 95% CI: 0.3, 1.6; only statistically significant RERI). CONCLUSIONS: Our results do not support a synergistic relationship between obesity and diabetes for most birth defects examined. However, there are opportunities for prevention by reducing obesity and improving glycemic control among women with pregestational diabetes before conception. |
Maternal use of specific antidepressant medications during early pregnancy and the risk of selected birth defects
Anderson KN , Lind JN , Simeone RM , Bobo WV , Mitchell AA , Riehle-Colarusso T , Polen KN , Reefhuis J . JAMA Psychiatry 2020 77 (12) 1246-1255 IMPORTANCE: Antidepressants are commonly used during pregnancy, but limited information is available about individual antidepressants and specific birth defect risks. OBJECTIVE: To examine associations between individual antidepressants and specific birth defects with and without attempts to partially account for potential confounding by underlying conditions. DESIGN, SETTING, AND PARTICIPANTS: The population-based, multicenter case-control National Birth Defects Prevention Study (October 1997-December 2011) included cases with selected birth defects who were identified from surveillance systems; controls were randomly sampled live-born infants without major birth defects. Mothers of cases and controls participated in an interview after the expected delivery date. The data were analyzed after the completion of the National Birth Defects Prevent Study's data collection. EXPOSURES: Self-reported antidepressant exposure was coded to indicate monotherapy exposure to antidepressants. MAIN OUTCOMES AND MEASURES: We used multivariable logistic regression to calculate adjusted odds ratios (aORs) and 95% confidence intervals for associations between maternal antidepressant use and birth defects. We compared early pregnancy antidepressant-exposed women with those without antidepressant exposure and, to partially account for confounding by underlying maternal conditions, those exposed to antidepressants outside of the birth defect development critical period. RESULTS: This study included 30 630 case mothers of infants with birth defects and 11 478 control mothers (aged 12-53 years). Early pregnancy antidepressant use was reported by 1562 case mothers (5.1%) and 467 control mothers (4.1%), for whom elevated aORs were observed for individual selective serotonin reuptake inhibitors (SSRIs) and selected congenital heart defects (CHD) (eg, fluoxetine and anomalous pulmonary venous return: aOR, 2.56; 95% CI, 1.10-5.93; this association was attenuated after partially accounting for underlying conditions: aOR, 1.89; 95% CI, 0.56-6.42). This pattern was observed for many SSRI-CHD combinations. Associations between SSRIs and non-CHD birth defects often persisted or strengthened after partially accounting for underlying conditions (eg, citalopram and diaphragmatic hernia: aOR, 5.11; 95% CI, 1.29-20.24). Venlafaxine had elevated associations with multiple defects that persisted after partially accounting for underlying conditions (eg, anencephaly and craniorachischisis: aOR, 9.14; 95% CI, 1.91-43.83). CONCLUSIONS AND RELEVANCE: We found some associations between maternal antidepressant use and specific birth defects. Venlafaxine was associated with the highest number of defects, which needs confirmation given the limited literature on venlafaxine use during pregnancy and risk for birth defects. Our results suggest confounding by underlying conditions should be considered when assessing risk. Fully informed treatment decision-making requires balancing the risks and benefits of proposed interventions against those of untreated depression or anxiety. |
Adverse pregnancy conditions among privately insured women with and without congenital heart defects
Downing KF , Tepper NK , Simeone RM , Ailes EC , Gurvitz M , Boulet SL , Honein MA , Howards PP , Valente AM , Farr SL . Circ Cardiovasc Qual Outcomes 2020 13 (6) Circoutcomes119006311 Background In women with congenital heart defects (CHD), changes in blood volume, heart rate, respiration, and edema during pregnancy may lead to increased risk of adverse outcomes and conditions. The American Heart Association recommends providers of pregnant women with CHD assess cardiac health and discuss risks and benefits of cardiac-related medications. We described receipt of American Heart Association-recommended cardiac evaluations, filled potentially teratogenic or fetotoxic (Food and Drug Administration pregnancy category D/X) cardiac-related prescriptions, and adverse conditions among pregnant women with CHD compared with those without CHD. Methods and Results Using 2007 to 2014 US healthcare claims data, we ascertained a retrospective cohort of women with and without CHD aged 15 to 44 years with private insurance covering prescriptions during pregnancy. CHD was defined as >/=1 inpatient code or >/=2 outpatient CHD diagnosis codes >30 days apart documented outside of pregnancy and categorized as severe or nonsevere. Log-linear regression, accounting for multiple pregnancies per woman, generated adjusted prevalence ratios (aPRs) for associations between the presence/severity of CHD and stillbirth, preterm birth, and adverse conditions from the last menstrual period to 90 days postpartum. We identified 2056 women with CHD (2334 pregnancies) and 1 374 982 women without (1 524 077 pregnancies). During the last menstrual period to 90 days postpartum, 56% of women with CHD had comprehensive echocardiograms and, during pregnancy, 4% filled potentially teratogenic or fetotoxic cardiac-related prescriptions. Women with CHD, compared with those without, experienced more adverse conditions overall (aPR, 1.9 [95% CI, 1.7-2.1]) and, specifically, obstetric (aPR, 1.3 [95% CI, 1.2-1.4]) and cardiac conditions (aPR, 10.2 [95% CI, 9.1-11.4]), stillbirth (aPR, 1.6 [95% CI, 1.1-2.4]), and preterm delivery (aPR, 1.6 [95% CI, 1.4-1.8]). More women with severe CHD, compared with nonsevere, experienced adverse conditions overall (aPR, 1.5 [95% CI, 1.2-1.9]). Conclusions Women with CHD have elevated prevalence of adverse cardiac and obstetric conditions during pregnancy; 4 in 100 used potentially teratogenic or fetotoxic medications, and only half received an American Heart Association-recommended comprehensive echocardiogram. |
Specific birth defects in pregnancies of women with diabetes: National Birth Defects Prevention Study, 1997-2011.
Tinker SC , Gilboa SM , Moore CA , Waller DK , Simeone RM , Kim SY , Jamieson DJ , Botto LD , Reefhuis J . Am J Obstet Gynecol 2019 222 (2) 176 e1-176 e11 BACKGROUND: Diabetes is associated with an increased risk for many birth defects and is likely to have an increasing impact on birth defect prevalence due to the rise in diabetes in the United States in recent decades. One of the first analyses in which specific birth defects were assessed for their relationship with both pregestational and gestational diabetes used data from the initial six years of the National Birth Defects Prevention Study. That analysis reported strong associations for pregestational diabetes with several birth defects, but few exposures among some of the less common birth defects led to unstable estimates with wide confidence intervals. Since that analysis, the study continued to collect data for another eight years, including information on approximately 19,000 additional cases and 6,900 additional controls. OBJECTIVES: Our objective was to use data from the National Birth Defects Prevention Study, the largest population-based birth defects case-control study in the United States, to provide updated and more precise estimates of the association between diabetes and birth defects, including some defects not previously assessed. STUDY DESIGN: We analyzed data on deliveries from October 1997 through December 2011. Mothers of case and control infants were interviewed about their health conditions and exposures during pregnancy, including diagnosis of pregestational (type 1 or type 2) diabetes before the index pregnancy or gestational diabetes during the index pregnancy. Using logistic regression, we separately assessed the association between pregestational and gestational diabetes with specific categories of structural birth defects for which there were at least three exposed case infants. For birth defect categories for which there were at least five exposed case infants, we calculated odds ratios adjusted for maternal body mass index, age, education, race/ethnicity, and study site; for defect categories with three or four exposed cases we calculated crude odds ratios. RESULTS: Pregestational diabetes was reported by 0.6 percent of mothers of control infants (71 / 11,447) and 2.5 percent of mothers of case infants (775 / 31,007). Gestational diabetes during the index pregnancy was reported by 4.7 percent of mothers of control infants (536 / 11,447) and 5.3 percent of mothers of case infants (1,653 / 31,007). Pregestational diabetes was associated with strong, statistically significant odds ratios (range: 2.5 to 80.2) for 46 of 50 birth defects considered. The largest odds ratio was observed for sacral agenesis (adjusted OR [aOR]: 80.2; 95% CI: 46.1, 139.3). A greater than 10-fold increased risk was also observed for holoprosencephaly (aOR: 13.1; 95% CI: 7.0, 24.5), longitudinal limb deficiency (aOR: 10.1; 95% CI: 6.2, 16.5), heterotaxy (aOR: 12.3; 95% CI: 7.3, 20.5), truncus arteriosus (aOR: 14.9; 95% CI: 7.6, 29.3), atrioventricular septal defect (aOR: 10.5; 95% CI: 6.2, 17.9), and single ventricle complex (aOR: 14.7; 95% CI: 8.9, 24.3).For gestational diabetes, statistically significant odds ratios were fewer (12 of 56) and of smaller magnitude (range: 1.3 to 2.1; 0.5 for gastroschisis). CONCLUSIONS: Pregestational diabetes is associated with markedly increased risk for many specific births defects. Because glycemic control before pregnancy is associated with a reduced risk for birth defects, ongoing quality care for persons with diabetes is an important opportunity for prevention. |
Update: Interim guidance for preconception counseling and prevention of sexual transmission of Zika virus for men with possible Zika virus exposure - United States, August 2018
Polen KD , Gilboa SM , Hills S , Oduyebo T , Kohl KS , Brooks JT , Adamski A , Simeone RM , Walker AT , Kissin DM , Petersen LR , Honein MA , Meaney-Delman D . MMWR Morb Mortal Wkly Rep 2018 67 (31) 868-871 Zika virus infection can occur as a result of mosquitoborne or sexual transmission of the virus. Infection during pregnancy is a cause of fetal brain abnormalities and other serious birth defects (1,2). CDC has updated the interim guidance for men with possible Zika virus exposure who 1) are planning to conceive with their partner, or 2) want to prevent sexual transmission of Zika virus at any time (3). CDC now recommends that men with possible Zika virus exposure who are planning to conceive with their partner wait for at least 3 months after symptom onset (if symptomatic) or their last possible Zika virus exposure (if asymptomatic) before engaging in unprotected sex. CDC now also recommends that for couples who are not trying to conceive, men can consider using condoms or abstaining from sex for at least 3 months after symptom onset (if symptomatic) or their last possible Zika virus exposure (if asymptomatic) to minimize their risk for sexual transmission of Zika virus. All other guidance for Zika virus remains unchanged. The definition of possible Zika virus exposure remains unchanged and includes travel to or residence in an area with risk for Zika virus transmission (https://wwwnc.cdc.gov/travel/page/world-map-areas-with-zika) or sex without a condom with a partner who traveled to or lives in an area with risk for Zika virus transmission. CDC will continue to update recommendations as new information becomes available. |
Proportion of orofacial clefts attributable to recognized risk factors
Raut JR , Simeone RM , Tinker SC , Canfield MA , Day RS , Agopian AJ . Cleft Palate Craniofac J 2018 56 (2) 1055665618774019 OBJECTIVE: Estimate the population attributable fraction (PAF) for a set of recognized risk factors for orofacial clefts. DESIGN: We used data from the National Birth Defects Prevention Study. For recognized risk factors for which data were available, we estimated crude population attributable fractions (cPAFs) to account for potential confounding, average-adjusted population attributable fractions (aaPAFs). We assessed 11 modifiable and 3 nonmodifiable parental/maternal risk factors. The aaPAF for individual risk factors and the total aaPAF for the set of risk factors were calculated using a method described by Eide and Geffler. SETTING: Population-based case-control study in 10 US states. PARTICIPANTS: Two thousand seven hundred seventy-nine cases with isolated cleft lip with or without cleft palate (CL+/-P), 1310 cases with isolated cleft palate (CP), and 11 692 controls with estimated dates of delivery between October 1, 1997, and December 31, 2011. MAIN OUTCOME MEASURES: Crude population attributable fraction and aaPAF. RESULTS: The proportion of CL+/-P and CP cases attributable to the full set of examined risk factors was 50% and 43%, respectively. The modifiable factor with the largest aaPAF was smoking during the month before pregnancy or the first month of pregnancy (4.0% for CL+/-P and 3.4% for CP). Among nonmodifiable factors, the factor with the largest aaPAF for CL+/-P was male sex (27%) and for CP it was female sex (16%). CONCLUSIONS: Our results may inform research and prevention efforts. A large proportion of orofacial cleft risk is attributable to nonmodifiable factors; it is important to better understand the mechanisms involved for these factors. |
Pregnancy outcomes after maternal Zika virus infection during pregnancy - U.S. territories, January 1, 2016-April 25, 2017
Shapiro-Mendoza CK , Rice ME , Galang RR , Fulton AC , VanMaldeghem K , Prado MV , Ellis E , Anesi MS , Simeone RM , Petersen EE , Ellington SR , Jones AM , Williams T , Reagan-Steiner S , Perez-Padilla J , Deseda CC , Beron A , Tufa AJ , Rosinger A , Roth NM , Green C , Martin S , Lopez CD , deWilde L , Goodwin M , Pagano HP , Mai CT , Gould C , Zaki S , Ferrer LN , Davis MS , Lathrop E , Polen K , Cragan JD , Reynolds M , Newsome KB , Huertas MM , Bhatangar J , Quinones AM , Nahabedian JF , Adams L , Sharp TM , Hancock WT , Rasmussen SA , Moore CA , Jamieson DJ , Munoz-Jordan JL , Garstang H , Kambui A , Masao C , Honein MA , Meaney-Delman D . MMWR Morb Mortal Wkly Rep 2017 66 (23) 615-621 Pregnant women living in or traveling to areas with local mosquito-borne Zika virus transmission are at risk for Zika virus infection, which can lead to severe fetal and infant brain abnormalities and microcephaly (1). In February 2016, CDC recommended 1) routine testing for Zika virus infection of asymptomatic pregnant women living in areas with ongoing local Zika virus transmission at the first prenatal care visit, 2) retesting during the second trimester for women who initially test negative, and 3) testing of pregnant women with signs or symptoms consistent with Zika virus disease (e.g., fever, rash, arthralgia, or conjunctivitis) at any time during pregnancy (2). To collect information about pregnant women with laboratory evidence of recent possible Zika virus infection* and outcomes in their fetuses and infants, CDC established pregnancy and infant registries (3). During January 1, 2016-April 25, 2017, U.S. territoriesdagger with local transmission of Zika virus reported 2,549 completed pregnancies section sign (live births and pregnancy losses at any gestational age) with laboratory evidence of recent possible Zika virus infection; 5% of fetuses or infants resulting from these pregnancies had birth defects potentially associated with Zika virus infection paragraph sign (4,5). Among completed pregnancies with positive nucleic acid tests confirming Zika infection identified in the first, second, and third trimesters, the percentage of fetuses or infants with possible Zika-associated birth defects was 8%, 5%, and 4%, respectively. Among liveborn infants, 59% had Zika laboratory testing results reported to the pregnancy and infant registries. Identification and follow-up of infants born to women with laboratory evidence of recent possible Zika virus infection during pregnancy permits timely and appropriate clinical intervention services (6). |
Inpatient hospitalization costs associated with birth defects among persons of all ages - United States, 2013
Arth AC , Tinker SC , Simeone RM , Ailes EC , Cragan JD , Grosse SD . MMWR Morb Mortal Wkly Rep 2017 66 (2) 41-46 In the United States, major structural or genetic birth defects affect approximately 3% of live births (1) and are responsible for 20% of infant deaths (2). Birth defects can affect persons across their lifespan and are the cause of significant lifelong disabilities. CDC used the Healthcare Cost and Utilization Project (HCUP) 2013 National Inpatient Sample (NIS), a 20% stratified sample of discharges from nonfederal community hospitals, to estimate the annual cost of birth defect-associated hospitalizations in the United States, both for persons of all ages and by age group. Birth defect-associated hospitalizations had disproportionately high costs, accounting for 3.0% of all hospitalizations and 5.2% of total hospital costs. The estimated annual cost of birth defect-associated hospitalizations in the United States in 2013 was $22.9 billion. Estimates of the cost of birth defect-associated hospitalizations offer important information about the impact of birth defects among persons of all ages on the overall health care system and can be used to prioritize prevention, early detection, and care. |
Using insurance claims data to identify and estimate critical periods in pregnancy: An application to antidepressants
Ailes EC , Simeone RM , Dawson AL , Petersen EE , Gilboa SM . Birth Defects Res A Clin Mol Teratol 2016 106 (11) 927-934 BACKGROUND: Health insurance claims are a rich data source to examine medication use in pregnancy. Our objective was to identify pregnant women, their pregnancy outcomes, and date of their last menstrual period (LMP), and to estimate antidepressant dispensations in pregnancy. METHODS: From a literature search, we identified diagnosis and procedure codes indicating the end of a pregnancy. Using Truven Health MarketScan(R) Commercial Claims and Encounters Databases, we identified all inpatient admissions and outpatient service claims with these codes. We developed an algorithm to assign: (1) pregnancy outcome (ectopic pregnancy, induced or spontaneous abortion, live birth, or stillbirth), and (2) estimated gestational age, to each inpatient or outpatient visit. For each pregnancy outcome, we estimated the LMP as the admission (for inpatient visits) or service (for outpatient visits) date minus the gestational age. To differentiate visits associated with separate pregnancies, we required ≥ 2 months between one pregnancy outcomes and the LMP of the next pregnancy. We used this algorithm to identify pregnancies in 2013 and to estimate the proportion of women who filled a prescription for an antidepressant from an outpatient pharmacy at various time points in pregnancy. RESULTS: We identified 488,887 pregnancies in 2013; 79% resulted in a live birth. A prescription for an antidepressant was filled in 6.2% of pregnancies. Dispensations varied throughout pregnancy and were lowest (3.1%) during the second trimester. CONCLUSION: This work will inform future efforts to estimate medication dispensations during critical periods of preconception, interconception, and pregnancy using health insurance claims data. |
Proportion of selected congenital heart defects attributable to recognized risk factors
Simeone RM , Tinker SC , Gilboa SM , Agopian AJ , Oster ME , Devine OJ , Honein MA . Ann Epidemiol 2016 26 (12) 838-845 PURPOSE: To assess the contribution of multiple risk factors for two congenital heart defects-hypoplastic left heart syndrome (HLHS) and tetralogy of Fallot (TOF). METHODS: We used data from the National Birth Defects Prevention Study (1997-2011) to estimate average adjusted population attributable fractions for several recognized risk factors, including maternal prepregnancy overweight-obesity, pregestational diabetes, age, and infant sex. RESULTS: There were 594 cases of isolated simple HLHS, 971 cases of isolated simple TOF, and 11,829 controls in the analysis. Overall, 57.0% of HLHS cases and 37.0% of TOF cases were estimated to be attributable to risk factors included in our model. Among modifiable HLHS risk factors, maternal prepregnancy overweight-obesity accounted for the largest proportion of cases (6.5%). Among modifiable TOF risk factors, maternal prepregnancy overweight-obesity and maternal age of 35 years or older accounted for the largest proportions of cases (8.3% and 4.3%, respectively). CONCLUSIONS: Approximately half of HLHS cases and one-third of TOF cases were estimated to be attributable to risk factors included in our models. Interventions targeting factors that can be modified may help reduce the risk of HLHS and TOF development. Additional research into the etiology of HLHS and TOF may reveal other modifiable risk factors that might contribute to primary prevention efforts. |
Estimating the Number of Pregnant Women Infected With Zika Virus and Expected Infants With Microcephaly Following the Zika Virus Outbreak in Puerto Rico, 2016.
Ellington SR , Devine O , Bertolli J , Martinez Quinones A , Shapiro-Mendoza CK , Perez-Padilla J , Rivera-Garcia B , Simeone RM , Jamieson DJ , Valencia-Prado M , Gilboa SM , Honein MA , Johansson MA . JAMA Pediatr 2016 170 (10) 940-945 Importance: Zika virus (ZIKV) infection during pregnancy is a cause of congenital microcephaly and severe fetal brain defects, and it has been associated with other adverse pregnancy and birth outcomes. Objective: To estimate the number of pregnant women infected with ZIKV in Puerto Rico and the number of associated congenital microcephaly cases. Design, Setting, and Participants: We conducted a modeling study from April to July 2016. Using parameters derived from published reports, outcomes were modeled probabilistically using Monte Carlo simulation. We used uncertainty distributions to reflect the limited information available for parameter values. Given the high level of uncertainty in model parameters, interquartile ranges (IQRs) are presented as primary results. Outcomes were modeled for pregnant women in Puerto Rico, which currently has more confirmed ZIKV cases than any other US location. Exposure: Zika virus infection in pregnant women. Main Outcomes and Measures: Number of pregnant women infected with ZIKV and number of congenital microcephaly cases. Results: We estimated an IQR of 5900 to 10300 pregnant women (median, 7800) might be infected during the initial ZIKV outbreak in Puerto Rico. Of these, an IQR of 100 to 270 infants (median, 180) may be born with microcephaly due to congenital ZIKV infection from mid-2016 to mid-2017. In the absence of a ZIKV outbreak, an IQR of 9 to 16 cases (median, 12) of congenital microcephaly are expected in Puerto Rico per year. Conclusions and Relevance: The estimate of 5900 to 10300 pregnant women that might be infected with ZIKV provides an estimate for the number of infants that could potentially have ZIKV-associated adverse outcomes. Including baseline cases of microcephaly, we estimated that an IQR of 110 to 290 total cases of congenital microcephaly, mostly attributable to ZIKV infection, could occur from mid-2016 to mid-2017 in the absence of effective interventions. The primary limitation in this analysis is uncertainty in model parameters. Multivariate sensitivity analyses indicated that the cumulative incidence of ZIKV infection and risk of microcephaly given maternal infection in the first trimester were the primary drivers of both magnitude and uncertainty in the estimated number of microcephaly cases. Increased information on these parameters would lead to more precise estimates. Nonetheless, the results underscore the need for urgent actions being undertaken in Puerto Rico to prevent congenital ZIKV infection and prepare for affected infants. |
Possible Zika virus infection among pregnant women - United States and Territories, May 2016
Simeone RM , Shapiro-Mendoza CK , Meaney-Delman D , Petersen EE , Galang RR , Oduyebo T , Rivera-Garcia B , Valencia-Prado M , Newsome KB , Perez-Padilla J , Williams TR , Biggerstaff M , Jamieson DJ , Honein MA , Ahmed F , Anesi S , Arnold KE , Barradas D , Barter D , Bertolli J , Bingham AM , Bollock J , Bosse T , Bradley KK , Brady D , Brown CM , Bryan K , Buchanan V , Bullard PD , Carrigan A , Clouse M , Cook S , Cooper M , Davidson S , DeBarr A , Dobbs T , Dunams T , Eason J , Eckert A , Eggers P , Ellington SR , Feldpausch A , Fredette CR , Gabel J , Glover M , Gosciminski M , Gay M , Haddock R , Hand S , Hardy J , Hartel ME , Hennenfent AK , Hills SL , House J , Igbinosa I , Im L , Jeff H , Khan S , Kightlinger L , Ko JY , Koirala S , Korhonen L , Krishnasamy V , Kurkjian K , Lampe M , Larson S , Lee EH , Lind L , Lindquist S , Long J , Macdonald J , MacFarquhar J , Mackie DP , Mark-Carew M , Martin B , Martinez-Quinones A , Matthews-Greer J , McGee SA , McLaughlin J , Mock V , Muna E , Oltean H , O'Mallan J , Pagano HP , Park SY , Peterson D , Polen KN , Porse CC , Rao CY , Ropri A , Rinsky J , Robinson S , Rosinger AY , Ruberto I , Schiffman E , Scott-Waldron C , Semple S , Sharp T , Short K , Signs K , Slavinski SA , Stevens T , Sweatlock J , Talbot EA , Tonzel J , Traxler R , Tubach S , Van Houten C , VinHatton E , Viray M , Virginie D , Warren MD , Waters C , White P , Williams T , Winters AI , Wood S , Zaganjor I . MMWR Morb Mortal Wkly Rep 2016 65 (20) 514-9 Zika virus is a cause of microcephaly and brain abnormalities (1), and it is the first known mosquito-borne infection to cause congenital anomalies in humans. The establishment of a comprehensive surveillance system to monitor pregnant women with Zika virus infection will provide data to further elucidate the full range of potential outcomes for fetuses and infants of mothers with asymptomatic and symptomatic Zika virus infection during pregnancy. In February 2016, Zika virus disease and congenital Zika virus infections became nationally notifiable conditions in the United States (2). Cases in pregnant women with laboratory evidence of Zika virus infection who have either 1) symptomatic infection or 2) asymptomatic infection with diagnosed complications of pregnancy can be reported as cases of Zika virus disease to ArboNET* (2), CDC's national arboviral diseases surveillance system. Under existing interim guidelines from the Council for State and Territorial Epidemiologists (CSTE), asymptomatic Zika virus infections in pregnant women who do not have known pregnancy complications are not reportable. ArboNET does not currently include pregnancy surveillance information (e.g., gestational age or pregnancy exposures) or pregnancy outcomes. To understand the full impact of infection on the fetus and neonate, other systems are needed for reporting and active monitoring of pregnant women with laboratory evidence of possible Zika virus infection during pregnancy. Thus, in collaboration with state, local, tribal, and territorial health departments, CDC established two surveillance systems to monitor pregnancies and congenital outcomes among women with laboratory evidence of Zika virus infection(dagger) in the United States and territories: 1) the U.S. Zika Pregnancy Registry (USZPR),( section sign) which monitors pregnant women residing in U.S. states and all U.S. territories except Puerto Rico, and 2) the Zika Active Pregnancy Surveillance System (ZAPSS), which monitors pregnant women residing in Puerto Rico. As of May 12, 2016, the surveillance systems were monitoring 157 and 122 pregnant women with laboratory evidence of possible Zika virus infection from participating U.S. states and territories, respectively. Tracking and monitoring clinical presentation of Zika virus infection, all prenatal testing, and adverse consequences of Zika virus infection during pregnancy are critical to better characterize the risk for congenital infection, the performance of prenatal diagnostic testing, and the spectrum of adverse congenital outcomes. These data will improve clinical guidance, inform counseling messages for pregnant women, and facilitate planning for clinical and public health services for affected families. |
Update: Ongoing Zika virus transmission - Puerto Rico, November 1, 2015 - April 14, 2016
Dirlikov E , Ryff KR , Torres-Aponte J , Thomas DL , Perez-Padilla J , Munoz-Jordan J , Caraballo EV , Garcia M , Segarra MO , Malave G , Simeone RM , Shapiro-Mendoza CK , Reyes LR , Alvarado-Ramy F , Harris AF , Rivera A , Major CG , Mayshack M , Alvarado LI , Lenhart A , Valencia-Prado M , Waterman S , Sharp TM , Rivera-Garcia B . MMWR Morb Mortal Wkly Rep 2016 65 (17) 451-5 Zika virus is a flavivirus transmitted primarily by Aedes species mosquitoes, and symptoms of infection can include rash, fever, arthralgia, and conjunctivitis. Zika virus infection during pregnancy is a cause of microcephaly and other severe brain defects. Infection has also been associated with Guillain-Barre syndrome. In December 2015, Puerto Rico became the first U.S. jurisdiction to report local transmission of Zika virus, with the index patient reporting symptom onset on November 23, 2015. This report provides an update to the epidemiology of and public health response to ongoing Zika virus transmission in Puerto Rico. During November 1, 2015-April 14, 2016, a total of 6,157 specimens from suspected Zika virus-infected patients were evaluated by the Puerto Rico Department of Health (PRDH) and CDC Dengue Branch (which is located in San Juan, Puerto Rico), and 683 (11%) had laboratory evidence of current or recent Zika virus infection by one or more tests: reverse transcription-polymerase chain reaction (RT-PCR) or immunoglobulin M (IgM) enzyme-linked immunosorbent assay (ELISA). Zika virus-infected patients resided in 50 (64%) of 78 municipalities in Puerto Rico. Median age was 34 years (range = 35 days-89 years). The most frequently reported signs and symptoms were rash (74%), myalgia (68%), headache (63%), fever (63%), and arthralgia (63%). There were 65 (10%) symptomatic pregnant women who tested positive by RT-PCR or IgM ELISA. A total of 17 (2%) patients required hospitalization, including 5 (1%) patients with suspected Guillain-Barre syndrome. One (<1%) patient died after developing severe thrombocytopenia. The public health response to the outbreak has included increased laboratory capacity to test for Zika virus infection (including blood donor screening), implementation of enhanced surveillance systems, and prevention activities focused on pregnant women. Vector control activities include indoor and outdoor residual spraying and reduction of mosquito breeding environments focused around pregnant women's homes. Residents of and travelers to Puerto Rico should continue to employ mosquito bite avoidance behaviors, take precautions to reduce the risk for sexual transmission, and seek medical care for any acute illness with rash or fever. |
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