93 results on '"Beigi RH"'
Search Results
2. Clinical review: Considerations for the triage of maternity care during an influenza pandemic - one institution's approach
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Beigi, RH, Hodges, J, Baldisseri, M, English, D, Beigi, RH, Hodges, J, Baldisseri, M, and English, D
- Abstract
The ongoing pandemic of 2009 H1N1 swine-origin influenza A has heightened the world's attention to the reality of influenza pandemics and their unpredictable nature. Currently, the 2009 H1N1 influenza strain appears to cause mild clinical disease for the majority of those infected. However, the risk of severe disease from this strain or other future strains remains an ongoing concern and is noted in specific patient populations. Pregnant women represent a unique patient population that historically has been disproportionately affected by both seasonal and pandemic influenza outbreaks. Data thus far suggest that the current 2009 H1N1 outbreak is following this same epidemiologic tendency among pregnant women. The increased predilection to worse clinical outcomes among pregnant women has potential to produce an acute demand for critical care resources that may overwhelm supply in facilities providing maternity care. The ability of healthcare systems to optimize maternal-child health outcomes during an influenza pandemic or other biologic disaster may therefore depend on the equitable allocation of these limited resources. Triage algorithms for resource allocation have been delineated in the general medical population. However, no current guidance considers the unique aspects of pregnant women and their unborn fetuses. An approach is suggested that may help guide facilities faced with these challenges. © 2010 BioMed Central Ltd. more...
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- 2010
Catalog
3. Preparedness planning for pandemic influenza among large US maternity hospitals
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Beigi, RH, primary, Davis, G, additional, Hodges, J, additional, and Akers, A, additional
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- 2009
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4. Antiviral medications for pregnant women for pandemic and seasonal influenza: an economic computer model.
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Lee BY, Bailey RR, Wiringa AE, Assi TM, Beigi RH, Lee, Bruce Y, Bailey, Rachel R, Wiringa, Ann E, Assi, Tina-Marie, and Beigi, Richard H
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- 2009
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5. Factors associated with absence of H2O2-producing lactobacillus among women with bacterial vaginosis.
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Beigi RH, Wiesenfeld HC, Hillier SL, Straw T, and Krohn MA
- Abstract
BACKGROUND: Women with bacterial vaginosis have different microbiological profiles. Our objective was to identify risk factors for an absence of H(2)O(2)-producing lactobacilli among women with bacterial vaginosis. METHODS: We performed a retrospective analysis of 947 women with bacterial vaginosis who were enrolled in prospective studies investigating vaginal colonization and genital-tract infections. RESULTS: Women were categorized into 2 groups: those with H(2)O(2)-producing lactobacilli present (n=191; 20.2%) and those with H(2)O(2)-producing lactobacilli absent (n=756; 79.8%). Multivariate logistic regression demonstrated that douching >/=2 times during the past month (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.1-6.0) and having >/=3 sex partners during the past year (OR, 4.5; 95% CI, 1.8-11.7) were predictive of an absence of H(2)O(2)-producing lactobacilli. CONCLUSION: Among women with bacterial vaginosis, H(2)O(2)-producing lactobacillus colonization is influenced by sexual activity and douching habits. These findings may have important implications for response to treatment, relapse rate, and risk for sexually-transmitted-disease acquisition among women with bacterial vaginosis. Copyright © 2005 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR] more...
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- 2005
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6. Vaginal yeast colonization in nonpregnant women: a longitudinal study.
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Beigi RH, Meyn LA, Moore DM, Krohn MA, and Hillier SL
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OBJECTIVE: We sought to investigate the prevalence and risk factors for vaginal yeast colonization over a 1-year period. METHODS: We conducted a longitudinal cohort study of 1,248 asymptomatic young women by collecting demographic and behavioral data at baseline, 4, 8, and 12 months. RESULTS: Seventy percent of women were colonized by vaginal yeast at one or more visits, but only 4% were colonized at all 4 visits. Using an adjusted generalized estimating equation model, factors associated with vaginal yeast colonization were marijuana use in the previous 4 months, depomedroxyprogesterone acetate use in the past 4 months, sexual intercourse in the previous 5 days, and concurrent colonization with lactobacilli and group B streptococcus. Symptoms of pruritus and vulvovaginal burning were associated with yeast colonization, but antifungal use was not. CONCLUSION: Recent sexual intercourse and use of injection contraceptives are risk factors for yeast colonization. Rates of antifungal use did not show an association with yeast colonization. The reporting of antifungal use by women lacking yeast colonization suggests that self-diagnosis is inaccurate. LEVEL OF EVIDENCE: II-2. [ABSTRACT FROM AUTHOR] more...
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- 2004
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7. COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn.
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Munoz FM, Posavad CM, Richardson BA, Badell ML, Bunge KE, Mulligan MJ, Parameswaran L, Kelly CW, Olson-Chen C, Novak RM, Brady RC, Pasetti MF, Defranco EA, Gerber JS, Shriver MC, Suthar MS, Coler RN, Berube BJ, Kim SH, Piper JM, Miller AM, Cardemil CV, Neuzil KM, and Beigi RH more...
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- Infant, Newborn, Female, Pregnancy, Humans, Antibodies, Neutralizing, COVID-19 Vaccines, Cohort Studies, Prospective Studies, SARS-CoV-2, Antibodies, Blocking, Antibodies, Viral, Vaccination, COVID-19 prevention & control, Pregnancy Complications, Infectious prevention & control
- Abstract
The immune response to COVID-19 booster vaccinations during pregnancy for mothers and their newborns and the functional response of vaccine-induced antibodies against Omicron variants are not well characterized. We conducted a prospective, multicenter cohort study of participants vaccinated during pregnancy with primary or booster mRNA COVID-19 vaccines from July 2021 to January 2022 at 9 academic sites. We determined SARS-CoV-2 binding and live virus and pseudovirus neutralizing antibody (nAb) titers pre- and post-vaccination, and at delivery for both maternal and infant participants. Immune responses to ancestral and Omicron BA.1 SARS-CoV-2 strains were compared between primary and booster vaccine recipients in maternal sera at delivery and in cord blood, after adjusting for days since last vaccination. A total of 240 participants received either Pfizer or Moderna mRNA vaccine during pregnancy (primary 2-dose series: 167; booster dose: 73). Booster vaccination resulted in significantly higher binding and nAb titers, including to the Omicron BA.1 variant, in maternal serum at delivery and in cord blood compared to a primary 2-dose series (range 0.44-0.88 log
10 higher, p < 0.0001 for all comparisons). Live virus nAb to Omicron BA.1 were present at delivery in 9 % (GMT ID50 12.7) of Pfizer and 22 % (GMT ID50 14.7) of Moderna primary series recipients, and in 73 % (GMT ID50 60.2) of mRNA boosted participants (p < 0.0001), although titers were significantly lower than to the D614G strain. Transplacental antibody transfer was efficient for all regimens with median transfer ratio range: 1.55-1.77 for IgG, 1.00-1.78 for live virus nAb and 1.79-2.36 for pseudovirus nAb. COVID-19 mRNA vaccination during pregnancy elicited robust immune responses in mothers and efficient transplacental antibody transfer to the newborn. A booster dose during pregnancy significantly increased maternal and cord blood binding and neutralizing antibody levels, including against Omicron BA.1. Findings support the use of a booster dose of COVID-19 vaccine during pregnancy., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: F.M.M. is an investigator of pediatric studies of COVID-19 vaccines for Pfizer and for a pediatric remdesivir study conducted by Gilead Sciences, Inc; serves as investigator on projects supported by an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as member of the Data Safety monitoring Board (DSMB) for clinical trials conducted by Pfizer, Moderna, Meissa Vaccines, Virometix, and the NIH; and is a member of the American Academy of Pediatrics Section of Infectious Diseases (SOID), the Immunization Expert Group of the American College of Obstetrics and Gynecology (ACOG), and was co-Chair of the COVAX-CEPI Maternal Immunization Working Group. K.M.N. is a member of the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization, serves as co-investigator on an NIH contract for a Vaccine Treatment and Evaluation Unit (VTEU), serves as Co-Chair of the NIH COVID Prevention Network (CoVPN), and served as an investigator for Phase I/II Pfizer COVID-19 vaccine grant, with a grant to the institution, but no salary support. M.J.M. conducts laboratory research and clinical trials with contract funding for vaccines or MABs vs SARS-CoV-2 with Lilly, Pfizer, and Sanofi and receives personal fees for Scientific Advisory Board service from Merck, Meissa Vaccines, Inc. and Pfizer. M.S.S. served as an advisor for Moderna (ended December 2021) and is currently serving as an advisor for Ocugen, Inc. B.A.R. currently holds a position on a DSMB for clinical trials at Gilead Sciences, Inc. R.C.B. at Cincinnati Children’s Hospital receives research grant support for clinical trials from PATH, Astra Zeneca and Pfizer on which she serves as co-investigator. B.B. owns shares in HDT Bio Corp. J.S.G. receives research funds from NIH for Moderna KidCOVE study. R.M.N. is a paid advisor to Gilead and an investigator on NIH-funded trials of Moderna, Pfizer and Janssen vaccines. J.R-K is a medical speaker for Abbott Nutrition with the UIC team. A.R.F. holds research grants from Pfizer, Janssen, Merck, Cyanvac, Biofire Diagnostics and serves on the DSMB for Novavax. N.R. receives funds to conduct industry trials from Pfizer, Merck, and Sanofi-Pasteur and serves as a safety consultant for EMMES and ICON. R.W.F. Jr., MD has received funds to conduct industry trials from Pfizer, Moderna and Astra Zeneca, serves on advisory boards for Merck, Sanofi-Pasteur, Johnson and Johnson and Seqirus and serves on an ICON-sponsored DSMB for a C difficile study., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.) more...- Published
- 2023
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8. Prospective Evaluation of Coronavirus Disease 2019 (COVID-19) Vaccine Responses Across a Broad Spectrum of Immunocompromising Conditions: the COVID-19 Vaccination in the Immunocompromised Study (COVICS).
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Haidar G, Agha M, Bilderback A, Lukanski A, Linstrum K, Troyan R, Rothenberger S, McMahon DK, Crandall MD, Sobolewksi MD, Nathan Enick P, Jacobs JL, Collins K, Klamar-Blain C, Macatangay BJC, Parikh UM, Heaps A, Coughenour L, Schwartz MB, Dueker JM, Silveira FP, Keebler ME, Humar A, Luketich JD, Morrell MR, Pilewski JM, McDyer JF, Pappu B, Ferris RL, Marks SM, Mahon J, Mulvey K, Hariharan S, Updike GM, Brock L, Edwards R, Beigi RH, Kip PL, Wells A, Minnier T, Angus DC, and Mellors JW more...
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- Adult, Antibodies, Viral, BNT162 Vaccine, COVID-19 Vaccines, Humans, Immunocompromised Host, Prospective Studies, SARS-CoV-2, Vaccination, COVID-19 prevention & control, HIV Infections complications
- Abstract
Background: We studied humoral responses after coronavirus disease 2019 (COVID-19) vaccination across varying causes of immunodeficiency., Methods: Prospective study of fully vaccinated immunocompromised adults (solid organ transplant [SOT], hematologic malignancy, solid cancers, autoimmune conditions, human immunodeficiency virus [HIV]) versus nonimmunocompromised healthcare workers (HCWs). The primary outcome was the proportion with a reactive test (seropositive) for immunoglobulin G to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain. Secondary outcomes were comparisons of antibody levels and their correlation with pseudovirus neutralization titers. Stepwise logistic regression was used to identify factors associated with seropositivity., Results: A total of 1271 participants enrolled: 1099 immunocompromised and 172 HCW. Compared with HCW (92.4% seropositive), seropositivity was lower among participants with SOT (30.7%), hematological malignancies (50.0%), autoimmune conditions (79.1%), solid tumors (78.7%), and HIV (79.8%) (P < .01). Factors associated with poor seropositivity included age, greater immunosuppression, time since vaccination, anti-CD20 monoclonal antibodies, and vaccination with BNT162b2 (Pfizer) or adenovirus vector vaccines versus messenger RNA (mRNA)-1273 (Moderna). mRNA-1273 was associated with higher antibody levels than BNT162b2 or adenovirus vector vaccines after adjusting for time since vaccination, age, and underlying condition. Antibody levels were strongly correlated with pseudovirus neutralization titers (Spearman r = 0.89, P < .0001), but in seropositive participants with intermediate antibody levels, neutralization titers were significantly lower in immunocompromised individuals versus HCW., Conclusions: Antibody responses to COVID-19 vaccines were lowest among SOT and anti-CD20 monoclonal recipients, and recipients of vaccines other than mRNA-1273. Among those with intermediate antibody levels, pseudovirus neutralization titers were lower in immunocompromised patients than HCWs. Additional SARS-CoV-2 preventive approaches are needed for immunocompromised persons, which may need to be tailored to the cause of immunodeficiency., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.) more...
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- 2022
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9. Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol.
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Munoz FM, Beigi RH, Posavad CM, Richardson BA, Chu HY, Bok K, Campbell J, Cardemil C, DeFranco E, Frenck RW, Makhene M, Piper JM, Sheffield J, Miller A, and Neuzil KM
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- Female, Humans, Infant, Infant, Newborn, Lactation, Multicenter Studies as Topic, Observational Studies as Topic, Pregnancy, Prospective Studies, COVID-19 prevention & control, COVID-19 Vaccines adverse effects
- Abstract
Background: Pregnant women were excluded from investigational trials of COVID-19 vaccines. Limited data are available to inform pregnant and postpartum women on their decisions to receive a COVID-19 vaccine., Methods: The goal of this observational, prospective cohort study is to evaluate the immunogenicity and safety of various Emergency Use Authorization (EUA) or licensed COVID-19 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in mothers and infants. The study is adaptive, allowing additional groups to be added as new vaccines or vaccine regimens are authorized. Up to 20 clinical research institutions in the United States (U.S.) will be included. Approximately 200 pregnant women and 65 postpartum women will be enrolled per EUA or licensed COVID-19 vaccine formulation in the U.S. This study will include pregnant and postpartum women of all ages with and without chronic medical conditions. Their infants will be enrolled and followed beginning at birth in the pregnant cohort and beginning at the earliest possible time point in the postpartum cohort. Blood samples will be collected for immunogenicity outcomes and pregnancy and birth outcomes assessed among women and infants. Primary analyses will be descriptive and done by vaccine type and/or platform., Discussion: Given the long-standing and legitimate challenges of enrolling pregnant individuals into clinical trials early in the vaccine development pipeline, this study protocol describes our current study and provides a template to inform the collection of data for pregnant individuals receiving COVID-19 or other vaccines., Trial Registration: NCT05031468 ., (© 2022. The Author(s).) more...
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- 2022
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10. Vaccine package inserts and prescribing habits of obstetricians-gynecologists for maternal vaccination.
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Saini J, Ellingson MK, Beigi RH, MacDonald NE, Top KA, Carroll S, and Omer SB
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- Cross-Sectional Studies, Female, Habits, Humans, Pregnancy, Product Labeling, United States, Vaccination, Diphtheria-Tetanus-acellular Pertussis Vaccines, Influenza Vaccines, Whooping Cough
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Despite ample evidence of the safety and efficacy of the influenza vaccine and the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine during pregnancy, two-thirds of pregnant women do not receive these vaccines. Providers have a significant role in increasing prenatal vaccine uptake. It is important to understand how different sources of vaccine prescribing information, such as Food and Drug Administration package inserts, influence provider recommendations. We aimed to examine the role of vaccine package inserts in provider recommendations and perceptions of safety and effectiveness of vaccines during pregnancy. A cross-sectional survey was mailed to a random, weighted sample of American College of Obstetricians and Gynecologists Fellows living in the United States in March 2019. Providers were asked about their attitudes toward package inserts, and to evaluate sample package insert statements following two different labeling rules. Their evaluations of each rule were then compared. Of the 321 respondents, the majority (90%, 288/321) recommended and/or administered maternal vaccinations. Few respondents (7.8%, 25/321) read package inserts for information regarding vaccination. Respondents were less likely to recommend sample vaccines with Pregnancy and Lactation Labeling Rule-complying inserts (46.1%, 148/321) than vaccines with Pregnancy Category inserts (87.5%, 282/321). Although most providers did not actively utilize vaccine package inserts to inform recommendations, the previous Pregnancy Categories rule was preferred compared to the Pregnancy and Lactation Labeling Rule. Collaborative efforts to update inserts with current clinical practices for pregnancy would be valuable in reducing apprehensiveness around package inserts to generate safer and more cogent recommendations for pregnant women. more...
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- 2021
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11. Should women undergoing in vitro fertilization treatment or who are in the first trimester of pregnancy be vaccinated immediately against COVID-19.
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Snook ML, Beigi RH, Legro RS, and Paules CI
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- Animals, COVID-19 complications, Female, Fetus drug effects, Humans, Pregnancy, Pregnancy Complications, Infectious virology, Pregnancy Trimester, First, Risk Factors, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Fertilization in Vitro, Pregnancy Complications, Infectious prevention & control, SARS-CoV-2 immunology
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- 2021
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12. Prioritization of pregnant individuals in state plans for coronavirus disease 2019 vaccination.
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Crane MA, Jaffe E, Beigi RH, Karron RA, Krubiner CB, Wonodi CB, and Faden RR
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- Female, Health Priorities, Humans, Pregnancy, United States, COVID-19 prevention & control, COVID-19 Vaccines supply & distribution, Pregnancy Complications, Infectious prevention & control
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- 2021
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13. Clinical Effectiveness and Safety of Antivirals for Influenza in Pregnancy.
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Chow EJ, Beigi RH, Riley LE, and Uyeki TM
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Seasonal influenza epidemics result in substantial health care burden annually. Early initiation of antiviral treatment of influenza has been shown to reduce the risk of complications and duration of illness. Pregnant and postpartum women may be at increased risk for influenza-associated complications; however, pregnant women have been generally excluded from clinical trials of antiviral treatment of influenza. In this review, we summarize the available evidence on the clinical effectiveness and safety of antiviral treatment of pregnant women with influenza. Observational data show a reduction of severe outcomes when pregnant and postpartum women are treated with oseltamivir and other neuraminidase inhibitors without increased risk of adverse maternal, fetal, or neonatal outcomes. Due to lack of safety and efficacy data for baloxavir treatment of pregnant and postpartum women, baloxavir is currently not recommended for use in these populations., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2021.) more...
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- 2021
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14. Management of Viral Complications of Pregnancy: Pharmacotherapy to Reduce Vertical Transmission.
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Rogan SC and Beigi RH
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- Adult, Antiviral Agents therapeutic use, COVID-19 therapy, COVID-19 transmission, Cytomegalovirus Infections therapy, Cytomegalovirus Infections transmission, Female, HIV Infections therapy, HIV Infections transmission, Hepatitis B therapy, Hepatitis B transmission, Hepatitis C therapy, Hepatitis C transmission, Herpes Simplex therapy, Herpes Simplex transmission, Humans, Infant, Pregnancy, Pregnancy Complications, Infectious virology, SARS-CoV-2, Infectious Disease Transmission, Vertical, Pregnancy Complications, Infectious therapy, Virus Diseases therapy, Virus Diseases transmission
- Abstract
Viral infections are common complications of pregnancy. Although some infections have maternal sequelae, many viral infections can be perinatally transmitted to cause congenital or chronic infection in fetuses or infants. Treatments of such infections are geared toward reducing maternal symptoms and complications and toward preventing maternal-to-child transmission of viruses. The authors review updates in the treatment of herpes simplex virus, cytomegalovirus, hepatitis B and C viruses, human immunodeficiency virus, and COVID-19 during pregnancy., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.) more...
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- 2021
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15. The need for inclusion of pregnant women in COVID-19 vaccine trials.
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Beigi RH, Krubiner C, Jamieson DJ, Lyerly AD, Hughes B, Riley L, Faden R, and Karron R
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- Female, Humans, Pregnancy, Pregnant People, Risk Factors, Vaccination ethics, Vaccination legislation & jurisprudence, Vaccination standards, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, Clinical Trials as Topic, Pregnancy Complications, Infectious prevention & control
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Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. more...
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- 2021
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16. Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response.
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Krubiner CB, Faden RR, Karron RA, Little MO, Lyerly AD, Abramson JS, Beigi RH, Cravioto AR, Durbin AP, Gellin BG, Gupta SB, Kaslow DC, Kochhar S, Luna F, Saenz C, Sheffield JS, and Tindana PO
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- Child, Female, Humans, Pregnancy, Pregnant People, Vaccination, Epidemics, Hemorrhagic Fever, Ebola, Influenza Vaccines, Vaccines, Zika Virus, Zika Virus Infection epidemiology, Zika Virus Infection prevention & control
- Abstract
Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group - a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy - in consultation with a variety of external experts and stakeholders., Competing Interests: Conflict of interest disclosure RAK has received grants from the Bill and Melinda Gates Foundation and PATH as well as personal fees from MERCK, outside the submitted work. JSA served as the Chair of the Global Alliance for Vaccines and Immunizations (Gavi) Vaccine Investment Strategic (VIS) Steering Committee (June 2017 – present) as well as the Co-chair of the Vaccine Innovation Prioritization Strategy Alliance (Gavi, WHO, UNICEF, Gates and PATH) Steering Committee (July 2018 – present) during the conduct of this work. BGG is President, Global Immunization at the Sabin Vaccine Institute. Sabin receives support from the Bill and Melinda Gates Foundation, Gavi, the National Philanthropic Trust, and private philanthropy. In addition, Sabin receives project-specific support from GlaxoSmithKline, Merck & Co., Pfizer, Sanofi Pasteur, Takeda Vaccines, Inc. None of this support is related to the focus of the PREVENT Working Group or the published Guidance. DCK has grant support from the Bill and Melinda Gates Foundation for work outside the scope of this Guidance. DCK oversees PATH's Center for Vaccine Innovation and Access (CVIA), which has grants from by the Bill and Melinda Gates Foundation for related work, including Advancing Maternal Immunization. The other authors do not have conflicts of interest to declare., (Copyright © 2019 Pan American Health Organization. Published by Elsevier Ltd.. All rights reserved.) more...
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- 2021
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17. Racial Differences in Postpartum Blood Pressure Trajectories Among Women After a Hypertensive Disorder of Pregnancy.
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Hauspurg A, Lemon L, Cabrera C, Javaid A, Binstock A, Quinn B, Larkin J, Watson AR, Beigi RH, and Simhan H
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- Adult, Black or African American statistics & numerical data, Cohort Studies, Female, Humans, Needs Assessment, Preventive Health Services, Risk Assessment methods, Risk Assessment statistics & numerical data, Risk Factors, United States epidemiology, White People statistics & numerical data, Blood Pressure physiology, Blood Pressure Determination methods, Blood Pressure Determination statistics & numerical data, Hypertension, Pregnancy-Induced diagnosis, Hypertension, Pregnancy-Induced ethnology, Hypertension, Pregnancy-Induced physiopathology, Postpartum Period physiology
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Importance: Maternal morbidity and mortality are increasing in the United States, most of which occur post partum, with significant racial disparities, particularly associated with hypertensive disorders of pregnancy. Blood pressure trajectory after a hypertensive disorder of pregnancy has not been previously described., Objectives: To describe the blood pressure trajectory in the first 6 weeks post partum after a hypertensive disorder of pregnancy and to evaluate whether blood pressure trajectories differ by self-reported race., Design, Setting, and Participants: This prospective cohort study included deliveries between January 1, 2018, and December 31, 2019. Women with a clinical diagnosis of a hypertensive disorder of pregnancy were enrolled in a postpartum remote blood pressure monitoring program at the time of delivery and were followed up for 6 weeks. Statistical analysis was performed from April 6 to 17, 2020., Main Outcomes and Measures: Mixed-effects regression models were used to display blood pressure trajectories in the first 6 weeks post partum., Results: A total of 1077 women were included (mean [SD] age, 30.2 [5.6] years; 804 of 1017 White [79.1%] and 213 of 1017 Black [20.9%]). Systolic and diastolic blood pressures were found to decrease rapidly in the first 3 weeks post partum, with subsequent stabilization (at 6 days post partum: mean [SD] peak systolic blood pressure, 146 [13] mm Hg; mean [SD] peak diastolic blood pressure, 95 [10] mm Hg; and at 3 weeks post partum: mean [SD] peak systolic blood pressure, 130 [12] mm Hg; mean [SD] peak diastolic blood pressure, 85 [9] mm Hg). A significant difference was seen in blood pressure trajectory by race, with both systolic and diastolic blood pressure decreasing more slowly among Black women compared with White women (mean [SD] peak systolic blood pressure at 1 week post partum: White women, 143 [14] mm Hg vs Black women, 146 [13] mm Hg; P = .01; mean [SD] peak diastolic blood pressure at 1 week post partum: White women, 92 [9] mm Hg vs Black women, 94 [9] mm Hg; P = .02; and mean [SD] peak systolic blood pressure at 3 weeks post partum: White women, 129 [11] mm Hg vs Black women, 136 [15] mm Hg; P < .001; mean [SD] peak diastolic blood pressure at 3 weeks post partum: White women, 84 [8] mm Hg vs Black women, 91 [13] mm Hg; P < .001). At the conclusion of the program, 126 of 185 Black women (68.1%) compared with 393 of 764 White women (51.4%) met the criteria for stage 1 or stage 2 hypertension (P < .001)., Conclusions and Relevance: This study found that, in the postpartum period, blood pressure decreased rapidly in the first 3 weeks and subsequently stabilized. The study also found that, compared with White women, Black women had a less rapid decrease in blood pressure, resulting in higher blood pressure by the end of a 6-week program. Given the number of women with persistent hypertension at the conclusion of the program, these findings also appear to support the importance of ongoing postpartum care beyond the first 6 weeks after delivery. more...
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- 2020
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18. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial.
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Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, Grassano L, Buffi G, Dreisbach A, Margarit I, Karsten A, Henry O, Lattanzi M, and Bebia Z
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- Adolescent, Adult, Female, Humans, Immunization, Immunogenicity, Vaccine, Infant, Pregnancy, Pregnant People, Streptococcus agalactiae, Young Adult, Streptococcal Infections prevention & control, Streptococcal Vaccines
- Abstract
Background: This study evaluated the safety and immunogenicity of an investigational trivalent group B streptococcus (GBS) vaccine in US pregnant women, transplacental serotype-specific antibody transfer and persistence in infants, and serotype-specific antibodies in breast milk., Methods: This randomized, observer-blind, placebo-controlled trial administered one dose of trivalent GBS vaccine (n = 49) or placebo (n = 26) to healthy pregnant 18-40-year-old women at 24
0/7 -346/7 weeks' gestation. Women were enrolled from March 2014 to August 2015. Safety follow-up continued through postpartum day 180. Primary immunogenicity objectives were to evaluate serotype Ia/Ib/III-specific immunoglobulin G (IgG) levels in sera from women on day 1 (pre-vaccination), day 31, delivery and postpartum days 42 and 90, and from infants at birth (cord blood), days 42 and 90. Antibody transfer ratios (cord blood/maternal sera at delivery) and serotype-specific secretory immunoglobulin A (sIgA) and IgG in breast milk after delivery and on postpartum days 42 and 90 were evaluated. The planned sample size was not based on statistical assumptions for this descriptive study., Results: Baseline characteristics were similar between groups. Serious adverse events were reported for 16% of GBS-vaccinated women and 15% of their infants, and 15% of placebo recipients and 12% of their infants; none were fatal or deemed vaccine-related. Serotype-specific IgG geometric mean concentrations (GMCs) were 13-23-fold higher in vaccine vs placebo recipients on day 31 and persisted until postpartum day 90. Median antibody concentrations were substantially higher in women with detectable pre-vaccination antibody concentrations. Antibody transfer ratios in the vaccine group were 0.62-0.82. Infant IgG GMCs and breast milk sIgA GMCs were higher in the vaccine vs the placebo group at all timepoints., Conclusions: Maternal immunization with the trivalent GBS vaccine in US women had a favorable safety profile, elicited antibodies that were transplacentally transferred and persisted in infants for a minimum of 3 months., Clinical Trial Registration: Clinicaltrials.gov, NCT02046148., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Z Bebia, M Lattanzi, O Henry, A Karsten, I Margarit, G Buffi and L Grassano are employees of the GSK group of companies. M Lattanzi, O Henry, A Karsten and I Margarit hold shares in the GSK group of companies. A Dreisbach was an employee of the GSK group of companies. GK Swamy, KM Edwards and JD Campbell report funding from the GSK group of companies for the work under consideration. TD Metz reports that her institution received funding from the GSK group of companies for the work under consideration. Outside the submitted work, GK Swamy is an advisor and chair of IDMCs for the GSK group of companies for RSV vaccine trials in pregnant women and chair of IDMCs for Pfizer for GBS vaccine trials in pregnant and nonpregnant women. Outside the submitted work, KM Edwards is an advisor to Bionet, X4 Pharmaceuticals, Merck, and IBM, and is on DSMBs for Moderna, Roche, Sanofi Pasteur and Sequiras. KM Edwards also reports grants from the CDC and the NIH. RH Beigi and DE Soper report no potential conflicts., (Copyright © 2020 GlaxoSmithKline Biologicals S.A. Published by Elsevier Ltd.. All rights reserved.) more...- Published
- 2020
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19. Trichomonas vaginalis , endometritis and sequelae among women with clinically suspected pelvic inflammatory disease.
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Wiringa AE, Ness RB, Darville T, Beigi RH, and Haggerty CL
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- Adult, Chlamydia Infections epidemiology, Chlamydia trachomatis, Female, Gonorrhea epidemiology, Humans, Live Birth epidemiology, Mycoplasma Infections epidemiology, Mycoplasma genitalium, Pelvic Inflammatory Disease drug therapy, Pregnancy, Recurrence, Risk Factors, Trichomonas vaginalis, United States epidemiology, Vaginosis, Bacterial epidemiology, Endometritis epidemiology, Infertility, Female epidemiology, Pelvic Inflammatory Disease epidemiology, Pregnancy Rate, Trichomonas Vaginitis epidemiology
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Objective: To ascertain the prevalence of Trichomonas vaginalis and investigate associations between trichomoniasis, endometritis and sequelae among women with pelvic inflammatory disease (PID)., Methods: We assessed the prevalence of trichomoniasis identified via wet mount and its association with histologically confirmed endometritis, infertility and recurrent PID among 647 women in the PID Evaluation and Clinical Health (PEACH) study. Participants were treated for clinically suspected PID and followed for a mean of 84 months for incident sequelae. Analyses were adjusted for age, race, Chlamydia trachomatis , Neisseria gonorrhoeae , Mycoplasma genitalium and bacterial vaginosis. Additional adjustments were incorporated for history of infertility (models of pregnancy and infertility), history of PID (recurrent PID), and self-reported partner treatment and intercourse between baseline and 30-day follow-up (persistent endometritis)., Results: T. vaginalis was present in the vagina of 12.8% of women. The odds of having endometritis at baseline were twice as high among women with trichomoniasis as compared with those without (adjusted OR (AOR): 1.9, 95% CI 1.0 to 3.3). Persistent endometritis was highly prevalent at 30 days (52.1%) and more common among women with baseline trichomoniasis (AOR: 2.6, 95% CI 0.7 to 10.1), although non-significantly. Infertility and recurrent PID were more common among women with trichomoniasis, while rates of pregnancy and live birth were lower., Conclusions: T. vaginalis was frequently isolated from the vagina of women with PID in the PEACH cohort. Wet mount microscopy for the identification of motile trichomonads was standard practice at the time of the PEACH study, but likely resulted in an underestimation of true T. vaginalis prevalence. Our findings of modest, although non-significant, prospective associations between trichomoniasis and sequelae are novel and underscore the need for additional investigation into whether T. vaginalis may play an aetiological role in adverse reproductive and gynaecological outcomes., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.) more...
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- 2020
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20. A cost-minimization analysis of treatment options for postmenopausal women with dysuria.
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Bradley MS, Beigi RH, and Shepherd JP
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- Costs and Cost Analysis, Decision Trees, Drug Combinations, Female, Fosfomycin economics, Fosfomycin therapeutic use, Humans, Nitrofurantoin economics, Nitrofurantoin therapeutic use, Sulfamethizole economics, Sulfamethizole therapeutic use, Trimethoprim economics, Trimethoprim therapeutic use, Urinary Tract Infections drug therapy, Urinary Tract Infections microbiology, Anti-Bacterial Agents economics, Anti-Bacterial Agents therapeutic use, Dysuria economics, Postmenopause, Urinalysis economics, Urinary Tract Infections diagnosis
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Background: Empiric therapy for urinary tract infection is difficult in postmenopausal women because of the higher rates of confounding lower urinary tract symptoms and differential resistance profiles of uropathogens in this population., Objective: The objective of the study was to determine the least costly strategy for treatment of postmenopausal women with the primary complaint of dysuria., Study Design: We performed a cost minimization analysis modeling the following clinical options: (1) empiric antibiotic therapy followed by urine culture, (2) urinalysis with empiric antibiotic therapy only if positive nitrites and leukocyte esterase, or (3) waiting for culture prior to initiating antibiotics. For all strategies we included nitrofurantoin, trimethoprim/sulfamethoxazole, fosfomycin, ciprofloxacin, or cephalexin. Pathogens included Escherichia coli, Enterococcus faecalis, Klebsiella pneumonaie, or Proteus mirabalis. Pathogens, resistance, treatment success, and medication side effects were specific to postmenopausal women., Results: Cost minimization modeling with TreeAge Pro assumed 73.4% of urinary tract infections were caused by Escherichia coli with 24.4% resistance to nitrofurantoin, trimethoprim/sulfamethoxazole. With our assumptions, empiric antibiotics with nitrofurantoin, trimethoprim/sulfamethoxazole was the least costly approach ($89.64/patient), followed by waiting for urine culture ($97.04/patient). Except for empiric antibiotics with fosfomcyin, empiric antibiotics was always less costly than using urinalysis to discriminate antibiotic use. This is due to the cost of urinalysis ($38.23), high rate of both urinary tract infection (91%), and positive urinalysis (69.3%) with dysuria in postmenopausal women and resultant high rate of antibiotic use with or without urinalysis. Options with fosfomycin were the most expensive because of the highest drug costs ($98/dose), and tornado analyses showed fosfomycin cost was the most impactful variable for model outcomes. Sensitivity analyses showed empiric fosfomycin became the least costly option if drug costs were $25.80, a price still more costly than almost all modeled baseline drug costs. This outcome was largely predicated on low resistance to fosfomycin. Conversely, ciprofloxacin was never the least costly option because of higher resistance and side effect cost, even if the drug cost was $0. We modeled 91% positive urine culture rate in postmenopausal women with dysuria; waiting for the urine culture prior to treatment would be the least costly strategy in a population with a predicted positive culture rate of <65%., Conclusion: The least costly strategy was empiric antibiotics with nitrofurantoin and trimethoprim/sulfamethoxazole, followed by waiting on culture results. Local resistance patterns will have an impact on cost minimization strategies. Empiric fosfomycin would be least costly with reduced drug costs, even at a level at which drug costs were higher than almost all other antibiotics. In a population with high posttest probability of positive urine culture, urinalysis adds unnecessary cost. Antibiotic stewardship programs should continue efforts to decrease fluoroquinolone use because of high resistance, side effects, and increased cost., (Copyright © 2019 Elsevier Inc. All rights reserved.) more...
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- 2019
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21. A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level.
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Hauspurg A, Lemon LS, Quinn BA, Binstock A, Larkin J, Beigi RH, Watson AR, and Simhan HN
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- Adult, Blood Pressure, Blood Pressure Determination methods, Feasibility Studies, Female, Humans, Hypertension, Pregnancy-Induced therapy, Postnatal Care methods, Postpartum Period, Pregnancy, Quality Improvement, Telemedicine methods, Blood Pressure Determination standards, Clinical Protocols standards, Hypertension therapy, Postnatal Care standards, Telemedicine standards
- Abstract
Objective: To evaluate the feasibility, acceptability, and compliance of a remote blood pressure monitoring protocol implemented as a quality improvement measure at the hospital level for management of hypertension in postpartum women after hospital discharge., Methods: This is an ongoing quality improvement project that included women admitted to the postpartum unit of a single tertiary care hospital. We designed nursing call center-driven blood pressure management and treatment algorithms, which were initiated after hospital discharge until 6 weeks postpartum. Women are eligible to participate if they have a diagnosis of chronic hypertension, superimposed preeclampsia, gestational hypertension, preeclampsia, or postpartum hypertension and have access to a text messaging-enabled smartphone device. After identification by an obstetric care provider, women are enrolled into the program, which is automatically indicated in the electronic medical record. Maternal, obstetric, and sociodemographic data were obtained from the electronic medical record., Results: Between February 2018 and January 2019, we enrolled 499 patients. Here we report on the first 409 enrolled patients. Participants include 168 (41%) with gestational hypertension, 179 (44%) with preeclampsia with no history of chronic hypertension, 49 (12%) with chronic hypertension with superimposed preeclampsia, and 13 (3%) with postpartum preeclampsia. One hundred seventy-one (42%) participants had antihypertensives initiated or titrated through the program. Three hundred forty women (83%) continued the program beyond 3 weeks postpartum, and 360 (88%) attended an in-person 6-week postpartum visit. Two hundred thirty-five out of 250 women who completed a postprogram survey (94%) reported satisfaction with the program., Conclusion: In this study, we detail results from an ongoing remote blood pressure monitoring program. We demonstrate high compliance, retention, and patient satisfaction with the program. This is a feasible, scalable remote monitoring program connected to the electronic medical record. more...
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- 2019
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22. Treatment of Viral Infections During Pregnancy.
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Rogan SC and Beigi RH
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- Female, Humans, Infant, Newborn, Maternal-Fetal Exchange, Pregnancy, Antiviral Agents therapeutic use, Cytomegalovirus Infections drug therapy, HIV Infections drug therapy, Hepatitis B, Chronic drug therapy, Hepatitis C, Chronic drug therapy, Herpes Simplex drug therapy, Infectious Disease Transmission, Vertical prevention & control, Pregnancy Complications, Infectious drug therapy
- Abstract
Viral infections are common complications of pregnancy. Although some infections have maternal sequelae, many viral infections can be perinatally transmitted to cause congenital or chronic infection in fetuses or infants. Treatments of such infections are geared toward reducing maternal symptoms and complications and toward preventing maternal-to-child transmission of viruses. This article reviews the treatment of herpes simplex virus, cytomegalovirus, hepatitis B and C viruses, and human immunodeficiency virus during pregnancy., (Copyright © 2019 Elsevier Inc. All rights reserved.) more...
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- 2019
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23. Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring.
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Noguchi LM, Hoesley C, Kelly C, Scheckter R, Bunge K, Nel A, Marzinke MA, Hendrix CW, Dezzutti CS, Hillier SL, Bogen DL, Piper JM, and Beigi RH
- Subjects
- Administration, Intravaginal, Adult, Anti-HIV Agents blood, Female, Humans, Lactation metabolism, Pyrimidines blood, Young Adult, Anti-HIV Agents pharmacokinetics, HIV Infections prevention & control, Milk, Human chemistry, Pyrimidines pharmacokinetics
- Abstract
Breastfeeding (BF) women are an important population for biomedical HIV prevention strategies, but they are rarely included in trials. The 25-mg dapivirine vaginal ring (VR) reduced women's risk of sexually transmitted HIV infection in two phase 3 trials conducted in Africa. We conducted a phase 1, open-label study (MTN-029/IPM 039) of dapivirine VR use among lactating women in Pittsburgh, PA, and Birmingham, AL, USA. MTN-029/IPM 039 enrolled 16 healthy adult women who had already weaned their infants but were still able to express breast milk. Women were instructed to use the VR continuously for 14 days and provided milk, plasma, and cervicovaginal fluid (CVF) samples for pharmacological analysis. No infants were exposed to the drug, but infant dosage was estimated according to FDA guidance. Adverse events (AEs) were collected at all contacts. The study was completed with 100% participant retention. Median dapivirine concentrations were 676 pg/ml in breast milk, 327 pg/ml in plasma (milk/plasma ratio ∼2.0), and 36.25 ng/mg in CVF. Six participants experienced 10 total AEs, none of which required VR discontinuation. The estimated mean daily infant dosage was 74.3 ng/kg/day. In this first study of dapivirine exposure during lactation, dapivirine VR use was associated with lower concentrations of detectable dapivirine in milk and plasma than in CVF samples and a favorable safety profile. Estimated daily levels of infant dapivirine exposure were also low. Additional studies are needed to evaluate longer periods of dapivirine VR use among BF mother-infant pairs living in regions with higher incidence of sexually transmitted HIV infection. (This study has been registered at ClinicalTrials.gov under registration no. NCT02808949.)., (Copyright © 2019 American Society for Microbiology.) more...
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- 2019
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24. Key steps forward for maternal immunization: Policy making in action.
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Beigi RH, Omer SB, and Thompson KM
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- Female, Humans, Pregnancy, Research, United States, Vaccination legislation & jurisprudence, Vaccination methods, Health Policy, Immunization legislation & jurisprudence, Immunization methods, Maternal Health Services legislation & jurisprudence, Policy Making
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- 2018
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25. Emerging Infectious Diseases in Pregnancy.
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Beigi RH
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- Communicable Diseases, Emerging etiology, Communicable Diseases, Emerging prevention & control, Disease Outbreaks, Female, Global Health, Hemorrhagic Fever, Ebola epidemiology, Hemorrhagic Fever, Ebola etiology, Hemorrhagic Fever, Ebola prevention & control, Humans, Influenza A Virus, H1N1 Subtype, Influenza, Human epidemiology, Influenza, Human etiology, Influenza, Human prevention & control, Maternal Health Services organization & administration, Pregnancy, Pregnancy Complications, Infectious etiology, Pregnancy Complications, Infectious prevention & control, Prenatal Care, Zika Virus Infection epidemiology, Zika Virus Infection etiology, Zika Virus Infection prevention & control, Communicable Diseases, Emerging epidemiology, Pregnancy Complications, Infectious epidemiology
- Abstract
It has been recognized for centuries that pregnant women have unique susceptibilities to many infectious diseases that predispose them to untoward outcomes compared with the general adult population. It is thought a combination of adaptive alterations in immunity to allow for the fetal allograft combined with changes in anatomy and physiology accompanying pregnancy underlie these susceptibilities. Emerging infectious diseases are defined as those whose incidence in humans has increased in the past two decades or threaten to increase in the near future. The past decade alone has witnessed many such outbreaks, each with its own unique implications for pregnant women and their unborn fetuses as well as lessons for the health care community regarding response and mitigation. Examples of such outbreaks include, but are not limited to, severe acute respiratory syndrome, the 2009 H1N1 pandemic influenza, Ebola virus, and, most recently, the Zika virus. Although each emerging pathogen has unique features requiring specific considerations, there are many underlying principles that are shared in the recognition, communication, and mitigation of such infectious outbreaks. Some of these key principles include disease-specific delineation of transmission dynamics, understanding of pathogen-specific effects on both mothers and fetuses, and advance planning and contemporaneous management that prioritize communication among public health experts, clinicians, and patients. The productive and effective working collaboration among the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine has been a key partnership in the successful communication and management of such outbreaks for women's health care providers and patients alike. Going forward, the knowledge gained over the past decade will undoubtedly continue to inform future responses and will serve to optimize the education and care given to pregnant women in the face of current and future emerging infectious disease outbreaks. more...
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- 2017
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26. Treatment of infections during pregnancy: Progress and challenges.
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Noguchi LM and Beigi RH
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- Adult, Child, Preschool, Communicable Disease Control trends, Communicable Diseases therapy, Female, Humans, Infant, Infant, Newborn, Malaria prevention & control, Mosquito Vectors, Pregnancy, Pregnancy Outcome epidemiology, Treatment Outcome, Zika Virus pathogenicity, Communicable Disease Control methods, Pregnancy Complications, Infectious etiology, Pregnancy Complications, Infectious therapy
- Abstract
Background: Emergence of Zika virus as a pathogen with important implications for perinatal outcomes highlights the need to identify safe and effective strategies for prevention and treatment of maternal infections., Methods: While substantial progress has been made in this area in recent years, significant regulatory and health systems barriers must still be overcome to identify and deliver evidence-based drug therapies for pregnant women., Results: We review progress and outstanding challenges associated with the identification and implementation of new treatment options for maternal infections., Conclusion: We describe several strategies in use to optimize the application of existing evidence.Birth Defects Research 109:387-390, 2017.© 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.) more...
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- 2017
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27. Text messages for influenza vaccination among pregnant women: A randomized controlled trial.
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Yudin MH, Mistry N, De Souza LR, Besel K, Patel V, Blanco Mejia S, Bernick R, Ryan V, Urquia M, Beigi RH, Moniz MH, and Sgro M
- Subjects
- Adult, Female, Gestational Age, Humans, Income statistics & numerical data, Influenza, Human immunology, Influenza, Human virology, Likelihood Functions, Marital Status statistics & numerical data, Patient Satisfaction statistics & numerical data, Pregnancy, Vaccination psychology, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Pregnant People psychology, Reminder Systems, Text Messaging, Vaccination statistics & numerical data
- Abstract
Objective: To evaluate if text message reminders increase the likelihood of receiving the influenza vaccine among pregnant women., Methods: Pregnant women were randomized to either receive or not receive weekly text messages. Women were told the messages would be about health-related behavior in pregnancy. Those randomized to the intervention group received two messages weekly for four consecutive weeks reinforcing that the influenza vaccine is recommended for all pregnant women and safe during pregnancy and breastfeeding. Women were contacted six weeks postpartum to determine if they had received the vaccine. Sample size calculation determined that 108 women were required in both groups to see a 75% increase in vaccination rates over baseline in the text message group compared to the control group., Results: Recruitment began November 4, 2013, and 317 women were randomized. The mean gestational age at recruitment was 22weeks. There were 40/129 (31%) women in the text message group and 41/152 (27%) women in the control group who received the vaccine (p=0.51). Significant predictors of vaccine acceptance were being married compared to single (95% vs. 67%, p<0.001), having higher household income (55% vs. 39%, p=0.03) and having received the vaccine before (77% vs. 36%, p<0.001). Among women receiving text messages, the majority were satisfied, with only 15/129 (12%) reporting that they did not like receiving the messages, and 24/129 (19%) stating that the information in the messages was not helpful., Conclusion: Weekly text messages reinforcing the recommendation for and safety of the influenza vaccine in pregnancy did not increase the likelihood of actually receiving the vaccine among pregnant women. Overall vaccination rates were low, highlighting the need for patient education and innovative techniques to improve vaccine acceptance. Registered with ClinicalTrials.gov at http://www.clinicaltrials.gov, registration number NCT 02428738., (Copyright © 2016 Elsevier Ltd. All rights reserved.) more...
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- 2017
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28. A randomized safety and pharmacokinetic trial of daily tenofovir 1% gel in term and near-term pregnancy.
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Beigi RH, Noguchi LM, Montgomery E, Biggio J, Hendrix CW, Marzinke MA, Dai JY, Pan J, Kunjara Na Ayudhya R, Schwartz JL, Isaacs K, Piper JM, and Watts DH
- Abstract
Introduction: Vaginal tenofovir (TFV) 1% gel may reduce incident HIV-1 and herpes simplex virus 2 infection. Pregnancy may increase risk of HIV acquisition, and incident HIV in pregnancy potentiates perinatal HIV transmission. Our objective was to investigate the safety and pharmacokinetics of seven days of TFV 1% vaginal gel in term and near-term pregnancy., Methods: Ninety-eight healthy pregnant women, stratified to a term cohort followed by a near-term cohort, were enrolled into a 2:1 randomized, double-blinded, placebo-controlled trial. Women received TFV or placebo gel for seven consecutive days with pharmacokinetic sampling on days 0 and 6. Maternal and cord blood were collected at delivery. Primary end points included laboratory and genital adverse events, adverse pregnancy and neonatal outcomes, and maternal TFV levels., Results: Most adverse events were grade 1 and none of the grade 3 or 4 adverse events were related to study product. There was no significant difference in safety end points between the two pregnancy cohorts ( p= 0.18); therefore, their data were combined. Primary safety end point rates were similar for mothers randomized to the TFV gel vs placebo arm (72.7 and 68.8%, p= 0.81). The same was true for newborns in the TFV gel vs placebo arms (4.5% vs 6.3%, p= 0.66). All women randomized to TFV had quantifiable serum levels within eight hours of dosing, with low overall median (interquartile range) day 0 and day 6 peak values (3.8 (2.0 to 7.0) and 5.8 (2.6 to 9.4) ng/mL, respectively)., Conclusions: Daily TFV 1% vaginal gel use in term and near-term pregnancy appears to be safe and produces low serum drug levels., Competing Interests: No authors have any conflicts of interest to disclose. more...
- Published
- 2016
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29. Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir.
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Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, Isaacs SK, Schwartz JL, Watts DH, and Beigi RH
- Subjects
- Adult, Breast Feeding, Female, HIV Infections blood, HIV Infections drug therapy, HIV Infections metabolism, HIV-1 drug effects, Humans, Infant, Lactation metabolism, Mothers, Tenofovir therapeutic use, Vaginal Creams, Foams, and Jellies pharmacokinetics, Vaginal Creams, Foams, and Jellies therapeutic use, Young Adult, Anti-HIV Agents blood, Milk, Human metabolism, Tenofovir blood, Tenofovir pharmacokinetics
- Abstract
Lactation studies are necessary evaluations of medications for reproductive-age women. We evaluated pharmacokinetics (PK), pharmacodynamics, safety, and adherence profiles associated with 7 days of 1% tenofovir (TFV) vaginal gel use during lactation. Tenofovir levels (maternal/infant serum, milk) and anti-HIV activity (milk), adverse events (AEs), and adherence were measured for 17 HIV-1-seronegative breast-feeding mother-infant pairs. Tenofovir use was well-tolerated and detected at low levels in maternal serum, milk, and infant serum but demonstrated no anti-HIV activity in milk., (Copyright © 2016, American Society for Microbiology. All Rights Reserved.) more...
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- 2016
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30. Performing Drug Safety Research During Pregnancy and Lactation: Biomedical HIV Prevention Research as a Template.
- Author
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Beigi RH, Noguchi L, Brown G, Piper J, and Watts DH
- Subjects
- Adult, Biomarkers, Pharmacological, Biomedical Research, Breast Feeding, Congresses as Topic, Female, Humans, Pregnancy, Pregnancy Complications, Infectious drug therapy, Anti-HIV Agents therapeutic use, HIV Infections prevention & control, Infectious Disease Transmission, Vertical prevention & control, Lactation, Pregnancy Complications, Infectious prevention & control
- Abstract
Evidence-based guidance regarding use of nearly all pharmaceuticals by pregnant and lactating women is limited. Models for performing research may assist in filling these knowledge gaps. Internationally, reproductive age women are at high risk of human immunodeficiency virus (HIV) acquisition. Susceptibility to HIV infection may be increased during pregnancy, and risk of maternal-child transmission is increased with incident HIV infection during pregnancy and lactation. A multidisciplinary meeting of experts was convened at the United States National Institutes of Health to consider paradigms for drug research in pregnancy and lactation applicable to HIV prevention. This report summarizes the meeting proceedings and describes a framework for research on candidate HIV prevention agent use during pregnancy and lactation that may also have broader applications to other pharmaceutical products. more...
- Published
- 2016
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31. Teratogenic effects of the Zika virus and the role of the placenta.
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Adibi JJ, Marques ETA Jr, Cartus A, and Beigi RH
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- Female, Humans, Microcephaly prevention & control, Pregnancy, Fetus virology, Microcephaly virology, Placenta immunology, Placenta virology, Teratogens, Zika Virus pathogenicity
- Abstract
The mechanism by which the Zika virus can cause fetal microcephaly is not known. Reports indicate that Zika is able to evade the normal immunoprotective responses of the placenta. Microcephaly has genetic causes, some associated with maternal exposures including radiation, tobacco smoke, alcohol, and viruses. Two hypotheses regarding the role of the placenta are possible: one is that the placenta directly conveys the Zika virus to the early embryo or fetus. Alternatively, the placenta itself might be mounting a response to the exposure; this response might be contributing to or causing the brain defect. This distinction is crucial to the diagnosis of fetuses at risk and the design of therapeutic strategies to prevent Zika-induced teratogenesis., (Copyright © 2016 Elsevier Ltd. All rights reserved.) more...
- Published
- 2016
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32. Pregnancy in the Time of Zika: Addressing Barriers for Developing Vaccines and Other Measures for Pregnant Women.
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Omer SB and Beigi RH
- Subjects
- Drug Labeling legislation & jurisprudence, Ethics, Research, Female, Humans, Pregnancy, Pregnancy Complications, Infectious virology, Safety, Zika Virus Infection virology, Pregnancy Complications, Infectious prevention & control, Pregnant People, Viral Vaccines administration & dosage, Viral Vaccines adverse effects, Zika Virus immunology, Zika Virus Infection prevention & control
- Published
- 2016
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33. Vaccination During Pregnancy.
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Moniz MH and Beigi RH
- Subjects
- Evidence-Based Medicine, Female, History, 19th Century, History, 20th Century, History, 21st Century, Humans, Pertussis Vaccine adverse effects, Physician-Patient Relations, Practice Guidelines as Topic, Pregnancy, Vaccination history, Diphtheria-Tetanus-acellular Pertussis Vaccines adverse effects, Influenza Vaccines adverse effects
- Abstract
Active immunization during pregnancy for maternal and neonatal benefit is a remarkably promising strategy to reduce infectious morbidity in both women and infants. The aim of this review is to present current clinical guidelines for vaccination during pregnancy and review evidence-based strategies for the implementation of maternal immunization recommendations. Observational studies, clinical trials, cost-effectiveness analyses, systematic reviews, and meta-analyses were evaluated to generate the evidence base for this review. In addition, recommendations from major national professional and public health organizations were examined. We present current clinical recommendations for vaccination during pregnancy and review medical and public health strategies to implement these guidelines. We also discuss a research agenda to advance the field of maternal immunization and achieve further improvements in maternal and child health. more...
- Published
- 2016
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34. Surgical Site Infection following Cesarean Delivery: Patient, Provider, and Procedure-Specific Risk Factors.
- Author
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Shree R, Park SY, Beigi RH, Dunn SL, and Krans EE
- Subjects
- Adult, Blood Loss, Surgical statistics & numerical data, Female, Humans, Insurance, Health statistics & numerical data, Internship and Residency statistics & numerical data, Logistic Models, Multivariate Analysis, Obstetrics education, Odds Ratio, Pregnancy, Private Practice statistics & numerical data, Retrospective Studies, Risk Factors, United States epidemiology, Uterine Hemorrhage epidemiology, Young Adult, Cesarean Section, Chorioamnionitis epidemiology, Fetal Distress epidemiology, Labor, Obstetric, Medicaid statistics & numerical data, Surgical Wound Infection epidemiology, Tobacco Use epidemiology
- Abstract
Objective: This study aims to identify risk factors for cesarean delivery (CD) surgical site infection (SSI). study design: Retrospective analysis of 2,739 CDs performed at the University of Pittsburgh in 2011. CD SSIs were defined using National Healthcare Safety Network (NHSN) criteria. Chi-square test and t-test were used for bivariate analyses and multivariate logistic regression was used to identify SSI risk factors., Results: Of 2,739 CDs, 178 (6.5%) were complicated by SSI. Patients with a SSI were more likely to have Medicaid, have resident physicians perform the CD, an American Society of Anesthesiologists (ASA) class of ≥ 3, chorioamnionitis, tobacco use, and labor before CD. In multivariable analysis, labor (odds ratio [OR], 2.35; 95% confidence interval [95% CI], 1.65-3.38), chorioamnionitis (OR, 2.24; 95% CI, 1.25-3.83), resident teaching service (OR, 2.15; 95% CI, 1.54-3.00), tobacco use (OR, 1.70; 95% CI, 1.04-2.70), ASA class ≥ 3 (OR, 1.61; 95% CI, 1.06-2.39), and CDs performed for nonreassuring fetal status (OR, 0.43; 95% CI, 0.26-0.67) were significantly associated with CD SSI., Conclusion: Multiple patient, provider, and procedure-specific risk factors contribute to CD SSI risk which may be targeted in infection-control efforts., Competing Interests: Statement: None of the authors have a conflict of interest to report., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.) more...
- Published
- 2016
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35. Maternal benefits of immunization during pregnancy.
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Swamy GK and Beigi RH
- Subjects
- Female, Humans, Immunization methods, Pregnancy, United States, Disease Transmission, Infectious prevention & control, Pregnancy Complications, Infectious prevention & control, Vaccines administration & dosage
- Abstract
The US Centers for Disease Control & Prevention currently recommend routine immunization to prevent 17 vaccine-preventable diseases that occur in infants, children, adolescents, or adults. Pregnant women are at particularly high risk for morbidity and mortality related to several vaccine-preventable diseases. Furthermore, such illnesses are also associated with adverse pregnancy outcomes such as spontaneous abortion, congenital anomalies, preterm birth, and low birthweight. In addition to directly preventing maternal infection, vaccination during pregnancy may offer fetal and infant benefit through passive immunization. Several vaccines aimed at providing passive immunity to neonates are either currently recommended or in development. This article specifically addresses maternal benefits of maternal immunization following (1) vaccines recommended for all pregnant women; (2) vaccines recommended for pregnant women with particular risk factors; and (3) novel vaccines currently under development that primarily aim to at reduce infant morbidity and mortality., (Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.) more...
- Published
- 2015
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36. Population pharmacokinetics of oseltamivir in non-pregnant and pregnant women.
- Author
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Pillai VC, Han K, Beigi RH, Hankins GD, Clark S, Hebert MF, Easterling TR, Zajicek A, Ren Z, Caritis SN, and Venkataramanan R
- Subjects
- Adolescent, Adult, Antiviral Agents blood, Computer Simulation, Female, Humans, Middle Aged, Models, Biological, Oseltamivir blood, Pregnancy, Young Adult, Antiviral Agents pharmacokinetics, Oseltamivir analogs & derivatives, Oseltamivir pharmacokinetics
- Abstract
Aims: Physiological changes in pregnancy are expected to alter the pharmacokinetics of various drugs. The objective of this study was to evaluate systematically the pharmacokinetics of oseltamivir (OS), a drug used in the treatment of influenza during pregnancy., Methods: A multicentre steady-state pharmacokinetic study of OS was performed in 35 non-pregnant and 29 pregnant women. Plasma concentration-time profiles were analyzed using both non-compartmental and population pharmacokinetic modelling (pop PK) and simulation approaches. A one compartment population pharmacokinetic model with first order absorption and elimination adequately described the pharmacokinetics of OS., Results: The systemic exposure of oseltamivir carboxylate (OC, active metabolite of OS) was reduced approximately 30 (19-36)% (P < 0.001) in pregnant women. Pregnancy significantly (P < 0.001) influenced the clearance (CL/F) and volume of distribution (V/F) of OC. Both non-compartmental and population pharmacokinetic approaches documented approximately 45 (23-62)% increase in clearance (CL/F) of OC during pregnancy., Conclusion: Based on the decrease in exposure of the active metabolite, the currently recommended doses of OS may need to be increased modestly in pregnant women in order to achieve comparable exposure with that of non-pregnant women., (© 2015 The British Pharmacological Society.) more...
- Published
- 2015
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37. The importance of studying antimicrobials in pregnancy.
- Author
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Beigi RH
- Subjects
- Adult, Anti-Infective Agents pharmacokinetics, Biomedical Research, Clinical Trials as Topic, Drug Approval, Drug Labeling, Drug Resistance, Viral, Evidence-Based Medicine, Female, Humans, Pregnancy, Pregnancy Complications, Infectious prevention & control, United States, Anti-Infective Agents administration & dosage, Infectious Disease Transmission, Vertical prevention & control, Pregnancy Complications, Infectious drug therapy, Pregnant People
- Abstract
Pregnant women and their unborn fetuses are a population with unique and heightened risks from a variety of infectious conditions. Sizable percentages of pregnant women receive antimicrobials during pregnancy for various indications. Despite this, many of the available antimicrobials in current use have inadequate data to fully inform evidence-based dosage recommendations to optimize clinical impact. Because of non-inclusion of pregnant women in clinical trials this situation exists and challenges the obstetric providers' ability to provide evidence-based treatment. Examples of the impact of the current status of exclusion of pregnant women from participation in clinical trials will be highlighted. In addition, successful models of research permitting safe and informative investigations of various antimicrobials in pregnancy will be discussed., (Copyright © 2015 Elsevier Inc. All rights reserved.) more...
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- 2015
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38. Text Messaging to Improve Preventive Health Attitudes and Behaviors During Pregnancy: A Prospective Cohort Analysis.
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Moniz MH, Meyn LA, and Beigi RH
- Subjects
- Adult, Breast Feeding, Cohort Studies, Condoms statistics & numerical data, Female, Humans, Intention, Pregnancy, Prospective Studies, Seat Belts statistics & numerical data, Smoking therapy, Smoking Cessation, Vitamins therapeutic use, Young Adult, Attitude to Health, Health Behavior, Pregnancy Complications prevention & control, Text Messaging
- Abstract
Objective: To delineate the effects of text messages sent to pregnant women to promote preventive health beliefs and behaviors., Study Design: A prospective cohort analysis was performed among women who participated in a randomized, controlled trial aimed at improving preventive health. Participants (158 pregnant women enrolled from 2010-2012) received 12 weekly text messages encouraging preventive health behaviors (tobacco cessation, condom use for disease prevention, nutrition optimization, seat belt use, breastfeeding). Pre- and postintervention surveys assessed preventive health beliefs and practices., Results: At follow-up, participants agreed that receiving text messages changed their beliefs about targeted preventive health behaviors: smoking (50%), sexually transmitted disease prevention (72%), prenatal vitamins (83%), seat belt use (68%), nutritious foods (84%), and breastfeeding (68%). Many participants reported more frequent engagement in target behaviors at follow-up than at baseline: decreased tobacco use (among 41% of smokers), more consistent condom use (among 7% of sexually active participants), more prenatal vitamin intake (32%), more frequent seatbelt use (32%), more frequent healthy food intake (41%), and intention to breastfeed longer (21%)., Conclusion: Pregnant women receiving text messages promoting preventive health reported improvements in targeted beliefs and behaviors, suggesting that text messaging may be used for health promotion during pregnancy. more...
- Published
- 2015
39. Risks Associated With Smallpox Vaccination in Pregnancy: A Systematic Review and Meta-analysis.
- Author
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Badell ML, Meaney-Delman D, Tuuli MG, Rasmussen SA, Petersen BW, Sheffield JS, Beigi RH, Damon IK, and Jamieson DJ
- Subjects
- Abortion, Spontaneous epidemiology, Congenital Abnormalities epidemiology, Female, Fetal Diseases virology, Humans, Pregnancy, Pregnancy Trimesters, Premature Birth epidemiology, Risk Assessment, Risk Factors, Smallpox Vaccine administration & dosage, Stillbirth epidemiology, Vaccinia virology, Smallpox Vaccine adverse effects
- Abstract
Objective: To estimate the maternal and fetal risks of smallpox vaccination during pregnancy., Data Sources: MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014., Methods of Study Selection: We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia)., Tabulations, Integration, and Results: The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76-1.41), stillbirth (pooled RR 1.03, CI 0.75-1.40), or preterm birth (pooled RR 0.84, CI 0.62-1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99-1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4% compared with 1.5%, pooled RR 1.34, CI 1.02-1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived., Conclusion: The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss. more...
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- 2015
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40. Clinical guidance for smallpox vaccine use in a postevent vaccination program.
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Petersen BW, Damon IK, Pertowski CA, Meaney-Delman D, Guarnizo JT, Beigi RH, Edwards KM, Fisher MC, Frey SE, Lynfield R, and Willoughby RE
- Subjects
- Biohazard Release, Bioterrorism, Disaster Planning, Humans, United States, Immunization Programs standards, Practice Guidelines as Topic, Smallpox prevention & control, Smallpox Vaccine administration & dosage
- Abstract
This report outlines recommendations for the clinical use of the three smallpox vaccines stored in the U.S. Strategic National Stockpile for persons who are exposed to smallpox virus or at high risk for smallpox infection during a postevent vaccination program following an intentional or accidental release of the virus. No absolute contraindications exist for smallpox vaccination in a postevent setting. However, several relative contraindications exist among persons with certain medical conditions. CDC recommendations for smallpox vaccine use were developed in consideration of the risk for smallpox infection, risk for an adverse event following vaccination, and benefit from vaccination. Smallpox vaccines are made from live vaccinia viruses that protect against smallpox disease. They do not contain variola virus, the causative agent of smallpox. The three smallpox vaccines stockpiled are ACAM2000, Aventis Pasteur Smallpox Vaccine (APSV), and Imvamune. Surveillance and containment activities including vaccination with replication-competent smallpox vaccine (i.e., vaccine viruses capable of replicating in mammalian cells such as ACAM2000 and APSV) will be the primary response strategy for achieving epidemic control. Persons exposed to smallpox virus are at high risk for developing and transmitting smallpox and should be vaccinated with a replication-competent smallpox vaccine unless severely immunodeficient. Because of a high likelihood of a poor immune response and an increased risk for adverse events, smallpox vaccination should be avoided in persons with severe immunodeficiency who are not expected to benefit from vaccine, including bone marrow transplant recipients within 4 months of transplantation, persons infected with HIV with CD4 cell counts <50 cells/mm3, and persons with severe combined immunodeficiency, complete DiGeorge syndrome, and other severely immunocompromised states requiring isolation. If antivirals are not immediately available, it is reasonable to consider the use of Imvamune in the setting of a smallpox virus exposure in persons with severe immunodeficiency. Persons without a known smallpox virus exposure might still be at high risk for developing smallpox infection depending on the magnitude of the outbreak and the effectiveness of the public health response. Such persons will be defined by public health authorities and should be screened for relative contraindications to smallpox vaccination. Relative contraindications include atopic dermatitis (eczema), HIV infection (CD4 cell counts of 50-199 cells/mm3), other immunocompromised states, and vaccine or vaccine-component allergies. Persons with relative contraindications should be vaccinated with Imvamune when available and authorized for use by the Food and Drug Administration. These recommendations will be updated as new data on smallpox vaccines become available and further clinical guidance for other medical countermeasures including antivirals is developed. more...
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- 2015
41. Reply letter regarding terminology in 'Maternal Immunization: Clinical experiences, challenges and opportunities in vaccine acceptance'.
- Author
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Moniz MH and Beigi RH
- Subjects
- Female, Humans, Pregnancy, Bacterial Vaccines administration & dosage, Immunity, Maternally-Acquired, Immunization methods, Immunization statistics & numerical data, Influenza Vaccines administration & dosage, Patient Acceptance of Health Care, Pregnancy Complications, Infectious prevention & control
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- 2015
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42. Maternal immunization: opportunities for scientific advancement.
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Beigi RH, Fortner KB, Munoz FM, Roberts J, Gordon JL, Han HH, Glenn G, Dormitzer PR, Gu XX, Read JS, Edwards K, Patel SM, and Swamy GK
- Subjects
- Clinical Trials as Topic, Female, Humans, Immunity, Maternally-Acquired, Immunization Programs, Infant, Influenza Vaccines, Influenza, Human prevention & control, Pregnancy, Tetanus prevention & control, United States, Whooping Cough prevention & control, Communicable Disease Control, Immunization, Pregnancy Complications, Infectious prevention & control, Vaccines administration & dosage, Vaccines adverse effects, Vaccines immunology
- Abstract
Maternal immunization is an effective strategy to prevent and/or minimize the severity of infectious diseases in pregnant women and their infants. Based on the success of vaccination programs to prevent maternal and neonatal tetanus, maternal immunization has been well received in the United States and globally as a promising strategy for the prevention of other vaccine-preventable diseases that threaten pregnant women and infants, such as influenza and pertussis. Given the promise for reducing the burden of infectious conditions of perinatal significance through the development of vaccines against relevant pathogens, the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH) sponsored a series of meetings to foster progress toward clinical development of vaccines for use in pregnancy. A multidisciplinary group of stakeholders convened at the NIH in December 2013 to identify potential barriers and opportunities for scientific advancement in maternal immunization., (© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.) more...
- Published
- 2014
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43. Oseltamivir for influenza in pregnancy.
- Author
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Beigi RH, Venkataramanan R, and Caritis SN
- Subjects
- Female, Humans, Pregnancy, Antiviral Agents therapeutic use, Influenza, Human drug therapy, Oseltamivir therapeutic use, Pregnancy Complications, Infectious drug therapy
- Abstract
Pregnancy predisposes women to disproportionate morbidity and mortality from influenza infections. This is true for both seasonal epidemics as well as occasional pandemics. Inactivated yearly influenza vaccines are the best available method of disease prevention and are recommended for all pregnant women in any trimester of pregnancy and postpartum. Oseltamivir (Tamiflu(®)) is currently the first-line recommended and most commonly used pharmaceutical agent for influenza prophylaxis and treatment. Oseltamivir has been demonstrated to prevent disease among exposed individuals, as well as to shorten the duration of illness and lessen the likelihood of complications among those infected. The physiologic adaptations of pregnancy may alter the pharmacokinetics and pharmacodynamics of this important drug. Updated evidence regarding these potential alterations, current knowledge gaps, and future investigative directions is discussed., (Copyright © 2014 Elsevier Inc. All rights reserved.) more...
- Published
- 2014
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44. Prevention and management of influenza in pregnancy.
- Author
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Beigi RH
- Subjects
- Adult, Female, Humans, Infant, Small for Gestational Age, Influenza, Human epidemiology, Influenza, Human immunology, Pregnancy, Pregnancy Complications, Infectious epidemiology, Pregnancy Complications, Infectious immunology, Premature Birth epidemiology, Premature Birth immunology, Prenatal Care, Risk Factors, Treatment Outcome, Chemoprevention methods, Infectious Disease Transmission, Vertical prevention & control, Influenza Vaccines administration & dosage, Influenza, Human prevention & control, Pregnancy Complications, Infectious prevention & control, Premature Birth prevention & control, Vaccination
- Abstract
Influenza infections are an important global source of morbidity and mortality. Pregnant and postpartum women are at increased risk for serious disease, related complications, and death from influenza infection. This increased risk is thought to be mostly caused by the altered physiologic and immunologic specifics of pregnancy. The morbidity of influenza infection during pregnancy is compounded by the potential for adverse obstetric, fetal, and neonatal outcomes. Importantly, influenza vaccination to prevent or minimize the severity of influenza infection during pregnancy (and the neonatal period) is recommended for all women who are or will be pregnant during influenza season., (Copyright © 2014 Elsevier Inc. All rights reserved.) more...
- Published
- 2014
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45. AN INTERVIEW TOOL TO PREDICT DISRUPTIVE PHYSICIAN BEHAVIOR.
- Author
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Sandy EA 2nd, Beigi RH, Cohel C, and Nash KC
- Subjects
- Humans, Pilot Projects, Professional Misconduct, Behavior, Interprofessional Relations, Personnel Selection methods, Physicians psychology
- Published
- 2014
46. Maternal immunization. Clinical experiences, challenges, and opportunities in vaccine acceptance.
- Author
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Moniz MH and Beigi RH
- Subjects
- Bacterial Vaccines immunology, Diphtheria prevention & control, Female, Humans, Influenza Vaccines immunology, Influenza, Human prevention & control, Pregnancy, Tetanus prevention & control, Whooping Cough prevention & control, Bacterial Vaccines administration & dosage, Immunity, Maternally-Acquired, Immunization methods, Immunization statistics & numerical data, Influenza Vaccines administration & dosage, Patient Acceptance of Health Care, Pregnancy Complications, Infectious prevention & control
- Abstract
Maternal immunization holds tremendous promise to improve maternal and neonatal health for a number of infectious conditions. The unique susceptibilities of pregnant women to infectious conditions, as well as the ability of maternally-derived antibody to offer vital neonatal protection (via placental transfer), together have produced the recent increased attention on maternal immunization. The Advisory Committee on Immunization Practices (ACIP) currently recommends 2 immunizations for all pregnant women lacking contraindication, inactivated Influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). Given ongoing research the number of vaccines recommended during pregnancy is likely to increase. Thus, achieving high vaccination coverage of pregnant women for all recommended immunizations is a key public health enterprise. This review will focus on the present state of vaccine acceptance in pregnancy, with attention to currently identified barriers and determinants of vaccine acceptance. Additionally, opportunities for improvement will be considered. more...
- Published
- 2014
- Full Text
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47. A multicenter cohort study of pregnancy outcomes among women with laboratory-confirmed H1N1 influenza.
- Author
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Naresh A, Fisher BM, Hoppe KK, Catov J, Xu J, Hart J, Lynch AM, Gibbs R, Eschenbach D, Gravett M, and Beigi RH
- Subjects
- Case-Control Studies, Cohort Studies, Female, Humans, Pregnancy, Pregnancy Complications, Premature Birth epidemiology, Influenza A Virus, H1N1 Subtype, Influenza, Human complications, Pregnancy Complications, Infectious, Pregnancy Outcome
- Abstract
Objective: To evaluate associations between laboratory-confirmed 2009 H1N1 influenza infection and obstetric and neonatal outcomes., Study Design: A multicenter cohort study was performed comparing laboratory-confirmed cases of 2009 H1N1 infection during pregnancy (N=142) with matched controls (N=710). Subanalysis was also performed comparing severely infected (hospitalized) women with controls., Result: No outcome differences were noted in comparing all women with H1N1 with controls. Women with severe infection had a higher incidence of delivering a small for gestational age (SGA) infant: 18.8% (6/32) versus 7.4% (52/707), adjusted odds ratio 2.35 (95% confidence interval 1.03, 5.36, P=0.02). Mean birth weight was 3013.0 g among severely infected women and 3223.3 g in controls (P=0.08), and incidence of preterm delivery was 25.0% (8/32) and 11.6% (82/710) (P=0.08), respectively., Conclusion: Pregnant women with mild clinical illness secondary to 2009 H1N1 were not at a greater risk of adverse pregnancy outcomes. However, severely infected women were more likely to deliver SGA infants. more...
- Published
- 2013
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48. Prophylaxis and treatment of anthrax in pregnant women.
- Author
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Meaney-Delman D, Rasmussen SA, Beigi RH, Zotti ME, Hutchings Y, Bower WA, Treadwell TA, and Jamieson DJ
- Subjects
- Female, Humans, Infant, Newborn, Pregnancy, Prenatal Exposure Delayed Effects, Abnormalities, Drug-Induced etiology, Anthrax prevention & control, Anti-Infective Agents pharmacology, Infant, Newborn, Diseases chemically induced, Pregnancy Complications, Infectious prevention & control
- Abstract
Objective: To review the safety and pharmacokinetics of antimicrobials recommended for anthrax postexposure prophylaxis and treatment in pregnant women., Data Sources: Articles were identified in the PubMed database from inception through December 2012 by searching the keywords (["pregnancy]" and [generic antibiotic drug name]). Additionally, we searched clinicaltrials.gov and conducted hand searches of references from REPROTOX, TERIS, review articles, and Briggs' Drugs in Pregnancy and Lactation., Methods of Study Selection: Articles included in the review contain primary data related to the safety and pharmacokinetics among pregnant women of 14 antimicrobials recommended for anthrax postexposure prophylaxis and treatment (amoxicillin, ampicillin, chloramphenicol, clindamycin, ciprofloxacin, doripenem, doxycycline, levofloxacin, linezolid, meropenem, moxifloxacin, penicillin, rifampin, and vancomycin)., Tabulation, Integration, and Results: The PubMed search identified 3,850 articles for review. Reference hand searching yielded nine additional articles. In total, 112 articles met the inclusion criteria., Conclusions: Overall, safety and pharmacokinetic information is limited for these antimicrobials. Although small increases in risks for certain anomalies have been observed with some antimicrobials recommended for prophylaxis and treatment of anthrax, the absolute risk of these antimicrobials appears low. Given the high morbidity and mortality associated with anthrax, antimicrobials should be dosed appropriately to ensure that antibiotic levels can be achieved and sustained. Dosing adjustments may be necessary for the β-lactam antimicrobials and the fluoroquinolones to achieve therapeutic levels in pregnant women. Data indicate that the β-lactam antimicrobials, the fluoroquinolones, and, to a lesser extent, clindamycin enter the fetal compartment, an important consideration in the treatment of anthrax, because these antimicrobials may provide additional fetal benefit in the second and third trimesters of pregnancy. more...
- Published
- 2013
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- View/download PDF
49. Research on vaccines during pregnancy: protocol design and assessment of safety.
- Author
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Munoz FM, Sheffield JS, Beigi RH, Read JS, Swamy GK, Jevaji I, Rasmussen SA, Edwards KM, Fortner KB, Patel SM, Spong CY, Ault K, Heine RP, and Nesin M
- Subjects
- Female, Humans, Infant, Newborn, Infant, Newborn, Diseases prevention & control, Pregnancy, Pregnancy Complications, Infectious prevention & control, Vaccination, Vaccines adverse effects, Vaccines therapeutic use, Clinical Trials as Topic methods, Research Design
- Abstract
The Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health organized a series of conferences, entitled "Enrolling Pregnant Women in Clinical Trials of Vaccines and Therapeutics", to discuss study design and the assessment of safety in clinical trials conducted in pregnant women. A panel of experts was charged with developing guiding principles for the design of clinical trials and the assessment of safety of vaccines during pregnancy. Definitions and a grading system to evaluate local and systemic reactogenicity, adverse events, and other events associated with pregnancy and delivery were developed. The purpose of this report is to provide investigators interested in vaccine research in pregnancy with a basic set of tools to design and implement maternal immunization studies which may be conducted more efficiently using consistent definitions and grading of adverse events to allow the comparison of safety reports from different trials. These guidelines and safety assessment tools may be modified to meet the needs of each particular protocol based on evidence collected as investigators use them in clinical trials in different settings and share their findings and expertise., (Copyright © 2013 Elsevier Ltd. All rights reserved.) more...
- Published
- 2013
- Full Text
- View/download PDF
50. Research on vaccines and antimicrobials during pregnancy: challenges and opportunities.
- Author
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Beigi RH, Goldkind SF, and Jevaji I
- Subjects
- Female, Humans, Infant, Newborn, Infant, Newborn, Diseases prevention & control, Pregnancy, Pregnancy Complications, Infectious prevention & control, Anti-Infective Agents therapeutic use, Vaccines therapeutic use
- Published
- 2013
- Full Text
- View/download PDF
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