Browsing by Author "Swamy, Geeta K"
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Item Open Access Blood lead levels among pregnant women: historical versus contemporaneous exposures.(Int J Environ Res Public Health, 2010-04) Miranda, Marie Lynn; Edwards, Sharon E; Swamy, Geeta K; Paul, Christopher J; Neelon, BrianBlood lead among pregnant women, even at modest levels, may impair offspring cognitive development. We examine whether blood lead levels (BLLs) result from current versus historic exposures, among a cohort of pregnant women. Cumulative logit models were used to characterize the relationship between maternal risk factors and higher BLLs. Maternal blood lead levels more likely result from lead remobilization from historic versus contemporaneous exposures. Even if all lead sources were abated immediately, women and their fetuses would experience lead exposure for decades. This work emphasizes the importance of addressing sources of environmental lead exposure in the United States and internationally.Item Open Access Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial.(AJP Rep, 2017-07) Gunatilake, Ravindu P; Swamy, Geeta K; Brancazio, Leo R; Smrtka, Michael P; Thompson, Jennifer L; Gilner, Jennifer B; Gray, Beverly A; Heine, Robert PhillipsBackground Postcesarean wound morbidity is a costly complication of cesarean delivery for which preventative strategies remain understudied.Objective We compared surgical site occurrences (SSOs) in cesarean patients receiving closed-incision negative-pressure therapy (ciNPT) or standard-of-care (SOC) dressing.Study Design A single-center randomized controlled trial compared ciNPT (5-7 days) to SOC dressing (1-2 days) in obese women (body mass index [BMI] ≥ 35), undergoing cesarean delivery between 2012 and 2014. Participants were randomized 1:1 and monitored 42 ± 10 days postoperatively. The primary outcome SSOs included unanticipated local inflammation, wound infection, seroma, hematoma, dehiscence, and need for surgical or antibiotic intervention.Results Of the 92 randomized patients, 82 completed the study. ciNPT and SOC groups had similar baseline characteristics. Mean BMI was 46.5 ± 6.5 and no treatment-related serious adverse events. Compared with SOC, the ciNPT group had fewer SSOs (7/43 [16.3%] vs. 2/39 [5.1%], respectively;p = 0.16); significantly fewer participants with less incisional pain both at rest (39/46 [84.8%] vs. 20/46 [43.5%];p < 0.001) and with incisional pressure (42/46 [91.3%] vs. 25/46 [54.3%];p < 0.001); and a 30% decrease in total opioid use (79.1 vs. 55.9 mg morphine equivalents,p = 0.036).Conclusion A trend in SSO reduction and a statistically significant reduction in postoperative pain and narcotic use was observed in women using ciNPT.Item Open Access Coronavirus disease 2019 vaccines in pregnancy.(American journal of obstetrics & gynecology MFM, 2020-12-10) Craig, Amanda M; Hughes, Brenna L; Swamy, Geeta KAs of December 1, 2020, nearly 64 million people have been infected with the severe acute respiratory syndrome coronavirus 2 worldwide with nearly 1.5 million global deaths. The impact of this virus has continued to overwhelm hospital infrastructure and demanded remodeling of healthcare systems. With rising concerns for a third, and possibly the largest, wave of individuals infected with the virus, national leaders are continuing to seek avenues by which we can further limit disease transmission and prevent infection with the use of vaccination. To our knowledge, no clinical trial evaluating vaccines to prevent coronavirus disease 2019 has included pregnant women. In December 2020, it was anticipated that the Food and Drug Administration will approve at least 1 or 2 mRNA-based coronavirus disease 2019 vaccine under the Emergency Use Authorization based on phase 3 clinical trial efficacy data. Both Pfizer and Moderna have manufactured mRNA-based vaccines with 95% and 94.1% efficacy against the severe acute respiratory syndrome coronavirus 2. AstraZeneca has manufactured a vaccine using a viral vector demonstrating early efficacy as well, and this next-generation platform has previously been utilized with the Ebola vaccine and safely administered during pregnancy with an acceptable safety profile. Approval of these vaccines will have a tremendous impact on the ongoing pandemic, yet there remains a lack of data for use of coronavirus disease 2019 vaccine in pregnant women. In this article, we seek to discuss the available data regarding treatment and prevention of coronavirus disease 2019 in pregnancy and address the growing questions regarding how best to approach vaccine access and administration in the pregnant population.Item Open Access Efficacy and safety of azithromycin versus placebo to treat lower respiratory tract infections associated with low procalcitonin: a randomised, placebo-controlled, double-blind, non-inferiority trial.(The Lancet. Infectious diseases, 2023-04) Tsalik, Ephraim L; Rouphael, Nadine G; Sadikot, Ruxana T; Rodriguez-Barradas, Maria C; McClain, Micah T; Wilkins, Dana M; Woods, Christopher W; Swamy, Geeta K; Walter, Emmanuel B; El Sahly, Hana M; Keitel, Wendy A; Mulligan, Mark J; Tuyishimire, Bonifride; Serti, Elisavet; Hamasaki, Toshimitsu; Evans, Scott R; Ghazaryan, Varduhi; Lee, Marina S; Lautenbach, Ebbing; TRAP-LRTI Study Group; Antibacterial Resistance Leadership GroupBackground
Lower respiratory tract infections are frequently treated with antibiotics, despite a viral cause in many cases. It remains unknown whether low procalcitonin concentrations can identify patients with lower respiratory tract infection who are unlikely to benefit from antibiotics. We aimed to compare the efficacy and safety of azithromycin versus placebo to treat lower respiratory tract infections in patients with low procalcitonin.Methods
We conducted a randomised, placebo-controlled, double-blind, non-inferiority trial at five health centres in the USA. Adults aged 18 years or older with clinically suspected non-pneumonia lower respiratory tract infection and symptom duration from 24 h to 28 days were eligible for enrolment. Participants with a procalcitonin concentration of 0·25 ng/mL or less were randomly assigned (1:1), in blocks of four with stratification by site, to receive over-encapsulated oral azithromycin 250 mg or matching placebo (two capsules on day 1 followed by one capsule daily for 4 days). Participants, non-study clinical providers, investigators, and study coordinators were masked to treatment allocation. The primary outcome was efficacy of azithromycin versus placebo in terms of clinical improvement at day 5 in the intention-to-treat population. The non-inferiority margin was -12·5%. Solicited adverse events (abdominal pain, vomiting, diarrhoea, allergic reaction, or yeast infections) were recorded as a secondary outcome. This trial is registered with ClinicalTrials.gov, NCT03341273.Findings
Between Dec 8, 2017, and March 9, 2020, 691 patients were assessed for eligibility and 499 were enrolled and randomly assigned to receive azithromycin (n=249) or placebo (n=250). Clinical improvement at day 5 was observed in 148 (63%, 95% CI 54 to 71) of 238 participants with full data in the placebo group and 155 (69%, 61 to 77) of 227 participants with full data in the azithromycin group in the intention-to-treat analysis (between-group difference -6%, 95% CI -15 to 2). The 95% CI for the difference did not meet the non-inferiority margin. Solicited adverse events and the severity of solicited adverse events were not significantly different between groups at day 5, except for increased abdominal pain associated with azithromycin (47 [23%, 95% CI 18 to 29] of 204 participants) compared with placebo (35 [16%, 12 to 21] of 221; between-group difference -7% [95% CI -15 to 0]; p=0·066).Interpretation
Placebo was not non-inferior to azithromycin in terms of clinical improvement at day 5 in adults with lower respiratory tract infection and a low procalcitonin concentration. After accounting for both the rates of clinical improvement and solicited adverse events at day 5, it is unclear whether antibiotics are indicated for patients with lower respiratory tract infection and a low procalcitonin concentration.Funding
National Institute of Allergy and Infectious Diseases, bioMérieux.Item Open Access Efficacy of Non-Beta-lactam Antibiotics for Prevention of Cesarean Delivery Surgical Site Infections.(AJP reports, 2019-04-30) Harris, Benjamin S; Hopkins, Maeve K; Villers, Margaret S; Weber, Jeremy M; Pieper, Carl; Grotegut, Chad A; Swamy, Geeta K; Hughes, Brenna L; Heine, R PhillipsObjective To examine the association between perioperative Beta ( β ))-lactam versus non- β -lactam antibiotics and cesarean delivery surgical site infection (SSI). Study Design Retrospective cohort of women undergoing cesarean delivery from January 1 to December 31, 2014. All women undergoing cesarean after 34 weeks with a postpartum visit were included. Prevalence of SSI was compared between women receiving β -lactam versus non- β -lactam antibiotics. Bivariate analyses were performed using Pearson's Chi-square, Fisher's exact, or Wilcoxon's rank-sum tests. Logistic regression models were fit controlling for possible confounders. Results Of the 929 women included, 826 (89%) received β -lactam prophylaxis and 103 (11%) received a non- β -lactam. Among the 893 women who reported a non-type I (low risk) allergy, 819 (92%) received β -lactam prophylaxis. SSI occurred in 7% of women who received β -lactam antibiotics versus 15% of women who received a non- β -lactam ( p = 0.004). β -Lactam prophylaxis was associated with lower odds of SSI compared with non- β -lactam antibiotics (odds ratio [OR] = 0.43; 95% confidence interval [CI] = 0.22-0.83; p = 0.01) after controlling for chorioamnionitis in labor, postlabor cesarean, endometritis, tobacco use, and body mass index (BMI). Conclusion β -Lactam perioperative prophylaxis is associated with lower odds of a cesarean delivery surgical site infection compared with non- β -lactam antibiotics.Item Open Access Engaging patients throughout the health system: A landscape analysis of cold-call policies and recommendations for future policy change.(Journal of clinical and translational science, 2018-12) McHugh, Kelly R; Swamy, Geeta K; Hernandez, Adrian FHealthcare institutions may often prohibit "cold-calling" or direct contact with a potential research participant when the person initiating contact is unknown to the patient. This policy aims to maintain patient privacy, but may have unintended consequences as a result of physician gatekeeping. In this review, we discuss recruitment policies at the top academic institutions. We propose an ethical framework for evaluating cold-call policies based on three principles of research ethics. In order to maximize engagement of potential research participants, while maintaining patient privacy and autonomy, we then propose several alternative solutions to restrictive cold-call policies, including opt-in or opt-out platforms, a team-based approach, electronic solutions, and best practices for recruitment. As healthcare has evolved with more collaborative, patient-centered, data-driven care, the engagement of potential research participants should similarly evolve.Item Open Access EngagINg the COmmunity to Reduce Preterm birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3): intervention development and future pilot study design.(The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2022-12) Wheeler, Sarahn M; Jackson, Maya; Massengale, Kelley EC; Ramey-Collier, Khaila; Østbye, Truls; Corneli, Amy; Bosworth, Hayden B; Swamy, Geeta KObjective
Non-Hispanic Black birthing individuals are at increased risk of preterm birth compared to other racial and ethnic groups. In our clinical setting, we offer a tailored package of recommendations to reduce the risk of preterm birth known as an individualized prematurity prevention plan (IP3). Patient-centered, community engaged interventions that address patient-perceived barriers to preterm birth prevention are urgently needed.Materials and methods
We engaged a group of stakeholders to develop a mutli-level (patient-centered and community-involved) intervention that will increase adherence to an individualized prematurity prevention plan (IP3) by addressing barriers identified during our prior qualitative studies.Results
The intervention includes trained doulas from a community-led, Black owned doula group. The doulas will moderate group prenatal social support sessions. In between the group sessions, participants will be encouraged to continue interacting with one another and the doulas using a private Facebook™ group page. We will pilot test the intervention in a cohort of pregnant, self-identified non-Hispanic Black patients with a history of prior preterm birth.Conclusion
We present a novel, patient-centered, community engaged intervention to reduce preterm birth in high-risk non-Hispanic Black birthing individuals. If the intervention is feasible based on the pilot study findings, we anticipate conducting an appropriately powered study to determine whether the intervention achieves our goal of reducing preterm birth.Item Open Access Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy.(The Journal of pediatrics, 2014-05) Cotten, C Michael; Murtha, Amy P; Goldberg, Ronald N; Grotegut, Chad A; Smith, P Brian; Goldstein, Ricki F; Fisher, Kimberley A; Gustafson, Kathryn E; Waters-Pick, Barbara; Swamy, Geeta K; Rattray, Benjamin; Tan, Siddhartha; Kurtzberg, JoanneObjective
To assess feasibility and safety of providing autologous umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE).Study design
We enrolled infants in the intensive care nursery who were cooled for HIE and had available UCB in an open-label study of non-cyropreserved autologous volume- and red blood cell-reduced UCB cells (up to 4 doses adjusted for volume and red blood cell content, 1-5 × 10(7) cells/dose). We recorded UCB collection and cell infusion characteristics, and pre- and post-infusion vital signs. As exploratory analyses, we compared cell recipients' hospital outcomes (mortality, oral feeds at discharge) and 1-year survival with Bayley Scales of Infant and Toddler Development, 3rd edition scores ≥85 in 3 domains (cognitive, language, and motor development) with cooled infants who did not have available cells.Results
Twenty-three infants were cooled and received cells. Median collection and infusion volumes were 36 and 4.3 mL. Vital signs including oxygen saturation were similar before and after infusions in the first 48 postnatal hours. Cell recipients and concurrent cooled infants had similar hospital outcomes. Thirteen of 18 (74%) cell recipients and 19 of 46 (41%) concurrent cooled infants with known 1-year outcomes survived with scores >85.Conclusions
Collection, preparation, and infusion of fresh autologous UCB cells for use in infants with HIE is feasible. A randomized double-blind study is needed.Item Open Access Geographic and Racial Disparities in Infant Hearing Loss.(Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2018-10-09) Lantos, Paul M; Maradiaga-Panayotti, Gabriela; Barber, Xavier; Raynor, Eileen; Tucci, Debara; Hoffman, Kate; Permar, Sallie R; Jackson, Pearce; Hughes, Brenna L; Kind, Amy; Swamy, Geeta KObjective Approximately 1 to 2 of every 1000 American newborns has hearing loss identified by newborn screening. This study was designed to determine if infant hearing loss is more common in socioeconomically disadvantaged communities. Study Design In this retrospective study, we analyzed electronic medical record data using geostatistical models. Setting Infants were residents of Durham County, North Carolina, born in 2 hospitals of the Duke University Health System. This county includes the city of Durham and surrounding suburban and rural communities. Subjects and Methods Subjects were hearing-screened newborns, born between 2005 and 2016, whose residential address was in Durham County, North Carolina. This was a retrospective study using medical record data. We used Bayesian regression models with smoothing of coordinate date to identify both spatial and nonspatial predictors of infant hearing loss. Results We identified 19,348 infants from Durham County, of whom 675 had failed initial hearing screening and 191 had hearing loss confirmed on follow-up. Hearing loss was significantly associated with minority race (odds ratio [OR], 2.45; 95% confidence interval, 1.97-3.06), as well as lower gestational age and maternal sexually transmitted infections. We identified significant geographic heterogeneity, with a higher probability of hearing loss in poorer urban neighborhoods (local OR range, 0.59-1.39). Neighborhood disadvantage was a significant predictor of hearing loss, as was high local seroprevalence of cytomegalovirus (CMV) among pregnant women. Conclusions Urban, low-income neighborhoods have a high prevalence of infant hearing loss compared with more affluent surrounding communities, particularly among minorities. This distribution may be attributable to congenital CMV infection.Item Open Access Group B Streptococcus (GBS) Colonization and Disease among Pregnant Women: A Historical Cohort Study.(Infectious diseases in obstetrics and gynecology, 2019-01) Edwards, James M; Watson, Nora; Focht, Chris; Wynn, Clara; Todd, Christopher A; Walter, Emmanuel B; Heine, R Phillips; Swamy, Geeta KBackground:Maternal GBS colonization is associated with early-onset neonatal sepsis and extensive efforts are directed to preventing this complication. Less is known about maternal risks of GBS colonization. We seek to provide a modern estimate of the incidence and impact of maternal GBS colonization and invasive GBS disease. Methods:A single center historical cohort study of all births between 2003 and 2015 was performed. Data was collected via electronic health record abstraction using an institutional specific tool. Descriptive statistics were performed regarding GBS status. Inferential statistics were performed comparing risk of adverse pregnancy outcomes in cohorts with and without GBS colonization as well as cohorts with GBS colonization and invasive GBS disease. Results:A total of 60,029 deliveries were included for analysis. Overall, 21.6% of the population was GBS colonized and 0.1% had invasive GBS disease. GBS colonization was associated with younger maternal age, Black race, non-Hispanic ethnicity, chronic hypertension, preexisting diabetes, and tobacco use (p<0.01). In the adjusted analyses, there was an increased risk of gestational diabetes (aRR 1.21, 95% CI 1.11-1.32) in colonized pregnancies and a decreased incidence of short cervix (aRR 0.64, 95% CI 0.52-0.79), chorioamnionitis (aRR 0.76, 95% CI 0.66-0.87), wound infection (aRR 0.75, 95% CI 0.64-0.88), and operative delivery (aRR 0.85, 95% CI 0.83-0.88). Conclusions:This modern-day large cohort of all births over a 12-year period demonstrates a GBS colonization rate of 21.6%. This data reflects a need to assess maternal and perinatal outcomes in addition to neonatal GBS sepsis rates to inform decisions regarding the utility of maternal vaccination.Item Open Access IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk.(Health equity, 2022-01) Wheeler, Sarahn M; Massengale, Kelley EC; Fitzgerald, Thelma A; Truong, Tracy; Østbye, Truls; Corneli, Amy; Swamy, Geeta KIntroduction
Preterm birth is a major cause of neonatal morbidity and mortality rate. Non-Hispanic black patients disproportionately experience preterm birth and nonadherence to evidence-based preventive measures. Interventions tailored to non-Hispanic black birthing individuals (NHBBIs) that address barriers to preterm birth preventions are urgently needed.Methods
Together with a community-engaged multidisciplinary stakeholder group, we developed an intervention to improve adherence to preterm birth preventions among black pregnant patients with prior preterm birth. The intervention included the following: (1) preterm birth prevention education, (2) an employment navigation toolkit, and (3) encouragement text messages. We piloted the intervention by recruiting self-identified non-Hispanic black patients at or before 20 weeks of gestation with a prior preterm birth and randomizing them to the intervention or an active control. The primary outcomes were feasibility and acceptability. Our secondary outcomes were preliminary efficacy based on birth outcomes, patient experience, and pregnancy-specific anxiety (PSA). Descriptive statistics, analysis of verbatim survey responses, Wilcoxon signed rank, and Fisher's exact were used to describe and compare quantitative and qualitative data.Results
We identified 53 individuals who met the inclusion criteria, 35 were reachable remotely and 30 were enrolled and randomized. More than 80% (n=26) were retained throughout the study, and 100% of participants identified at least one intervention component as helpful. In this small pilot, there were no detectable differences in adherence to preterm birth preventive recommendations. No difference in preterm births, other pregnancy, or patient experience outcomes was detected between the intervention and active control participants.Discussion
The intervention is feasible and acceptable. Larger, appropriately powered studies are needed to assess whether the intervention will decrease PSA and reduce preterm birth. This trial was registered with ClinicalTrials.gov (NCT04933812).Item Open Access Influenza vaccination of household contacts of newborns: a hospital-based strategy to increase vaccination rates.(Infect Control Hosp Epidemiol, 2010-10) Walter, Emmanuel B; Allred, Norma J; Swamy, Geeta K; Hellkamp, Anne S; Dolor, Rowena JWe implemented a hospital-based influenza vaccination program for household contacts of newborns. Among mothers not vaccinated prenatally, 44.7% were vaccinated through the program, as were 25.7% of fathers. A hospital-based program provided opportunities for vaccination of household contacts of newborns, thereby facilitating better adherence to national vaccination guidelines.Item Open Access Maternal Effects of Respiratory Syncytial Virus Infection during Pregnancy.(Emerg Infect Dis, 2015-11) Wheeler, Sarahn M; Dotters-Katz, Sarah; Heine, R Phillip; Grotegut, Chad A; Swamy, Geeta KGiven the illness and deaths caused by respiratory syncytial virus (RSV) infection during the first year of life, preventing infant RSV infections through maternal vaccination is intriguing. However, little is known about the extent and maternal effects of RSV infection during pregnancy. We describe 3 cases of maternal RSV infection diagnosed at a US center during winter 2014. Case-patient 1 (26 years old, week 33 of gestation) received a diagnosis of RSV infection and required mechanical ventilation. Case-patient 2 (27 years old, week 34 of gestation) received a diagnosis of infection with influenza A(H1N1) virus and RSV and required mechanical ventilation. Case-patient 3 (21 years old, week 32 of gestation) received a diagnosis of group A streptococcus pharyngitis and RSV infection and was monitored as an outpatient. Clarifying the effects of maternal RSV infection could yield valuable insights into potential maternal and fetal benefits of an effective RSV vaccination program.Item Open Access Non-reassuring fetal status: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.(Vaccine, 2016-12-01) Gravett, Courtney; Eckert, Linda O; Gravett, Michael G; Dudley, Donald J; Stringer, Elizabeth M; Mujobu, Tresor Bodjick Muena; Lyabis, Olga; Kochhar, Sonali; Swamy, Geeta K; Brighton Collaboration Non-reassuring fetal status Working GroupItem Open Access Postnatal cytomegalovirus exposure in infants of antiretroviral-treated and untreated HIV-infected mothers.(Infect Dis Obstet Gynecol, 2014) Meyer, Sarah A; Westreich, Daniel J; Patel, Emily; Ehlinger, Elizabeth P; Kalilani, Linda; Lovingood, Rachel V; Denny, Thomas N; Swamy, Geeta K; Permar, Sallie RHIV-1 and CMV are important pathogens transmitted via breastfeeding. Furthermore, perinatal CMV transmission may impact growth and disease progression in HIV-exposed infants. Although maternal antiretroviral therapy reduces milk HIV-1 RNA load and postnatal transmission, its impact on milk CMV load is unclear. We examined the relationship between milk CMV and HIV-1 load (4-6 weeks postpartum) and the impact of antiretroviral treatment in 69 HIV-infected, lactating Malawian women and assessed the relationship between milk CMV load and postnatal growth in HIV-exposed, breastfed infants through six months of age. Despite an association between milk HIV-1 RNA and CMV DNA load (0.39 log(10) rise CMV load per log(10) rise HIV-1 RNA load, 95% CI 0.13-0.66), milk CMV load was similar in antiretroviral-treated and untreated women. Higher milk CMV load was associated with lower length-for-age (-0.53, 95% CI: -0.96, -0.10) and weight-for-age (-0.40, 95% CI: -0.67, -0.13) Z-score at six months in exposed, uninfected infants. As the impact of maternal antiretroviral therapy on the magnitude of postnatal CMV exposure may be limited, our findings of an inverse relationship between infant growth and milk CMV load highlight the importance of defining the role of perinatal CMV exposure on growth faltering of HIV-exposed infants.Item Open Access Pregnant Women's Knowledge and Beliefs about the Safety and Outcomes of Delivery at Various Gestational Ages.(AJP Rep, 2018-01) Baldwin, Melody A; Swamy, Geeta K; Wheeler, Sarahn MObjectives Despite the morbidity associated with late preterm and early-term births, there is limited data on pregnant women's perception of neonatal risk based on gestational age (GA). Therefore, our objective was to determine pregnant women's perception of neonatal risks at varying GAs. Method Through an anonymous 24-question survey, pregnant women were asked to designate the GA at delivery that is desirable, safe, and defined as full term. Responses were compared based on race, history of preterm birth, and medical comorbidities. Results Among the 233 survey respondents, the majority (62.9%) desired delivery at 36 to 39 weeks' gestation. Black women were more likely to desire delivery at 28 to 35 weeks compared with other racial/ethnic groups ( p = 0.005). Women with a history of preterm birth or medical complications were less likely to desire delivery at 40 weeks. More than 40% of respondents thought delivery at 8 months of pregnancy was safe and 40.3% responded that 37 weeks' gestation is considered term. Conclusion Misconceptions surrounding the definition of a term pregnancy are pervasive and vary by race, obstetric history, and medical comorbidities. Our findings highlight the need for patient education about appropriate gestational length, especially in minority and high-risk populations.Item Open Access Re: COVID-19 vaccine in pregnant women: not so far! The importance of counselling and the need for evidence-based data.(American journal of obstetrics & gynecology MFM, 2021-02) Craig, Amanda M; Hughes, Brenna L; Swamy, Geeta KItem Open Access Supporting researchers through full-service hotline and consultation services: Success in simplicity, customization, and staffing.(Journal of clinical and translational science, 2020-02) Brouwer, Rebecca Namenek; Miller, Emily; Patil, Sunita; Swamy, Geeta K; Moen, Rebbecca; McMillan, Amanda; Boulware, L EbonyNavigating the research domain at an academic medical center can be challenging, even for seasoned investigators. To address this, Duke University launched two initiatives: (1) a research navigation "hotline" to provide brief assistance with a variety of research questions; and (2) researcher onboarding and consultation, a one-to-one tailored offering to ensure that researchers are equipped to navigate research resources and processes effectively. The services are provided by the myRESEARCHnavigators (MRN) team, funded by Duke's CTSA. The diverse scientific backgrounds of the six team members align well with those of the research community, allowing for a good match between the researcher and MRN team member. The MRN team answers approximately 30 questions per month, and has provided consultations to almost 400 researchers. Both services receive high satisfaction ratings (4 or 5 stars [out of 5 stars] given to 90% of hotline answers, and 99% of researcher onboarding/consultation sessions). As of July 2019, the School of Medicine has determined that the consultations are critical to their mission and have made them a requirement for new research faculty. The team will continue marketing both services to encourage adoption.Item Open Access The Excess Burden of Cytomegalovirus in African American Communities: A Geospatial Analysis.(Open Forum Infect Dis, 2015-12) Lantos, Paul M; Permar, Sallie R; Hoffman, Kate; Swamy, Geeta KBackground. Cytomegalovirus (CMV) is a common cause of birth defects and hearing loss in infants and opportunistic infections in the immunocompromised. Previous studies have found higher CMV seroprevalence rates among minorities and among persons with lower socioeconomic status. No studies have investigated the geographic distribution of CMV and its relationship to age, race, and poverty in the community. Methods. We identified patients from 6 North Carolina counties who were tested in the Duke University Health System for CMV immunoglobulin G. We performed spatial statistical analyses to analyze the distributions of seropositive and seronegative individuals. Results. Of 1884 subjects, 90% were either white or African American. Cytomegalovirus seropositivity was significantly more common among African Americans (73% vs 42%; odds ratio, 3.31; 95% confidence interval, 2.7-4.1), and this disparity persisted across the life span. We identified clusters of high and low CMV odds, both of which were largely explained by race. Clusters of high CMV odds were found in communities with high proportions of African Americans. Conclusions. Cytomegalovirus seropositivity is geographically clustered, and its distribution is strongly determined by a community's racial composition. African American communities have high prevalence rates of CMV infection, and there may be a disparate burden of CMV-associated morbidity in these communities.Item Open Access Varicella zoster immune globulin (VARIZIG) administration up to 10 days after varicella exposure in pregnant women, immunocompromised participants, and infants: Varicella outcomes and safety results from a large, open-label, expanded-access program.(PloS one, 2019-01) Levin, Myron J; Duchon, Jennifer M; Swamy, Geeta K; Gershon, Anne AINTRODUCTION:Despite vaccination, there were more than 100,000 annual cases of varicella in the United States in 2013-2014. Individuals at highest risk of developing severe or complicated varicella include immunocompromised people, preterm infants, and pregnant women. Varicella zoster immune globulin (human) (VARIZIG) is recommended by the CDC for postexposure prophylaxis to prevent or attenuate varicella-zoster virus infection in high-risk individuals. Contemporary information on administration of VARIZIG is limited. METHODS:This open-label, expanded-access program provided VARIZIG to physician-identified, high-risk participants exposed to varicella. Participants included immunocompromised children/adults, infants (preterm, newborns whose mothers had varicella onset within 5 days before or 2 days after delivery, and those aged <1 year), and pregnant women. VARIZIG (125 IU/10 kg [up to 625 IU]) was administered intramuscularly, ideally within 96 hours, but up to 10 days, postexposure. Incidence of varicella rash and severity (>100 pox, pneumonia, or encephalitis) were assessed up to 42 days after administration. RESULTS:The varicella outcome population (n = 507) included 263 immunocompromised participants (32 adults, 231 children), 137 pregnant women, 105 infants, and 2 healthy adults with no history of varicella. Varicella incidence was 4.5% in immunocompromised participants, 7.3% in pregnant women, and 11.5% in infants. The incidence of varicella was similar when comparing VARIZIG administration ≤ 96 hours vs > 96 hours (up to 10 days) postexposure in the entire population (6.2% vs. 9.4%, respectively), and also in each subgroup. Of 34 participants with varicella, 5 developed > 100 pox and 1 developed pneumonia and encephalitis. There were no product-related deaths and only 1 serious adverse event (serum sickness) considered probably related to VARIZIG. CONCLUSION:Postexposure administration of VARIZIG was associated with low rates of varicella in high-risk participants, regardless of when administered within 10 days postexposure. VARIZIG was well-tolerated and safe in high-risk participants.