Data Revues 00029378 Unassign S0002937814010631, Jul 11, 2014
were utilized to analyze the frequency of certain perinatal risk factors that were associated wit... more were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP.
Planned home birth is a paradigmatic case study of the importance of ethics and professionalism i... more Planned home birth is a paradigmatic case study of the importance of ethics and professionalism in contemporary perinatology. In this article we provide a summary of recent analyses of the Centers for Disease Control database on attendants and birth outcomes in the United States. This summary documents the increased risks of neonatal mortality and morbidity of planned home birth as well as bias in Apgar scoring. We then describe the professional responsibility model of obstetric ethics, which is based on the professional medical ethics of two major figures in the history of medical ethics, Drs. John Gregory of Scotland and Thomas Percival of England. This model emphasizes the identification and careful balancing of the perinatologist's ethical obligations to pregnant, fetal, and neonatal patients. This model stands in sharp contrast to one-dimensional maternal-rights-based reductionist model of obstetric ethics, which is based solely on the pregnant woman's rights. We then identify the implications of the professional responsibility model for the perinatologist's role in directive counseling of women who express an interest in or ask about planned home birth. Perinatologists should explain the evidence of the increased, preventable perinatal risks of planned home birth, recommend against it, and recommend planned hospital birth. Perinatologists have the professional responsibility to create and sustain a strong culture of safety committed to a home-birth-like experience in the hospital. By routinely fulfilling these professional responsibilities perinatologists can help to prevent the documented, increased risks planned home birth.
American journal of obstetrics and gynecology, 2015
We analyzed the perinatal risks of midwife-attended planned home births in the United States from... more We analyzed the perinatal risks of midwife-attended planned home births in the United States from 2010 through 2012 and compared them with recommendations from the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) for planned home births. Data from the US Centers for Disease Control and Prevention's National Center for Health Statistics birth certificate data files from 2010 through 2012 were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP. Midwife-attended planned home births in t...
Background: The Apgar score is used worldwide to assess the newborn infant shortly after birth. A... more Background: The Apgar score is used worldwide to assess the newborn infant shortly after birth. Apgar scores, including mean scores and those with high cut-off scores, have been used to support claims that planned home birth is as safe as hospital birth. The purpose of this study was to determine the distribution of 5 min Apgar scores among different birth settings and providers in the USA. Methods: We obtained data from the National Center for Health Statistics of the US Centers for Disease Control birth certificate data for 2007-2010 for all singleton, term births of infants weighing ≥2500 g (n=13,830,531). Patients were then grouped into six categories by birth setting and birth attendant: hospital-based physician, hospital-based midwife, freestanding birth center with either certified nurse midwife and/or other midwife, and home-based delivery with either certified nurse midwife or other midwife. The distribution of each Apgar score from 0 to 10 was assessed for each group. Resu...
ABSTRACT Data from 103 litters of albino rats were analyzed for the effects of the number of fetu... more ABSTRACT Data from 103 litters of albino rats were analyzed for the effects of the number of fetuses in the litter and in each uterine horn, resorptions, and intra-uterine position on variations in fetal weight. The right uterine horn tended to contain more fetuses than the left. There ...
ABSTRACT This study was conducted to determine if there is a greater variation in fetal weight an... more ABSTRACT This study was conducted to determine if there is a greater variation in fetal weight and/or placental weight among litters of rat fetuses than within a single litter. Three hundred and twenty-seven litters comprising 1,979 fetal and placental weights were analyzed using ...
Assessing the risk profiles of potentially sensitive populations requires a ''tool chest'' of met... more Assessing the risk profiles of potentially sensitive populations requires a ''tool chest'' of methodological approaches to adequately characterize and evaluate these populations. At present, there is an extensive body of literature on methodologies that apply to the evaluation of the pediatric population. The Health and Environmental Sciences Institute Subcommittee on Risk Assessment of Sensitive Populations evaluated key references in the area of pediatric risk to identify a spectrum of methodological approaches. These approaches are considered in this article for their potential to be extrapolated for the identification and assessment of other sensitive populations. Recommendations as to future research needs and/or alternate methodological considerations are also made.
There is significant public concern about the potential health effects of exposure to mercury vap... more There is significant public concern about the potential health effects of exposure to mercury vapour (Hg(0)) released from dental amalgam restorations. The purpose of this article is to provide information about the toxicokinetics of Hg(0), evaluate the findings from the recent scientific and medical literature, and identify research gaps that when filled may definitively support or refute the hypothesis that dental amalgam causes adverse health effects. Dental amalgam is a widely used restorative dental material that was introduced over 150 years ago. Most standard dental amalgam formulations contain approximately 50% elemental mercury. Experimental evidence consistently demonstrates that Hg(0) is released from dental amalgam restorations and is absorbed by the human body. Numerous studies report positive correlations between the number of dental amalgam restorations or surfaces and urine mercury concentrations in non-occupationally exposed individuals. Although of public concern, it is currently unclear what adverse health effects are caused by the levels of Hg(0) released from this restoration material. Historically, studies of occupationally exposed individuals have provided consistent information about the relationship between exposure to Hg(0) and adverse effects reflecting both nervous system and renal dysfunction. Workers are usually exposed to substantially higher Hg(0) levels than individuals with dental amalgam restorations and are typically exposed 8 hours per day for 20-30 years, whereas persons with dental amalgam restorations are exposed 24 hours per day over some portion of a lifetime. This review has uncovered no convincing evidence pointing to any adverse health effects that are attributable to dental amalgam restorations besides hypersensitivity in some individuals.
a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected ... more a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers "mere opinion" as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.
Birth defects are an urgent global health priority. They affect millions of births worldwide. But... more Birth defects are an urgent global health priority. They affect millions of births worldwide. But their prevalence and impact are largely under-ascertained, particularly in middle- and low-income countries. Fortunately, a large proportion of birth defects can be prevented. This review examines the global prevalence and primary prevention methods for major preventable birth defects: congenital rubella syndrome, folic acid-preventable spina bifida and anencephaly, fetal alcohol syndrome, Down syndrome, rhesus hemolytic disease of the fetus and the newborn; and those associated with maternal diabetes, and maternal exposure to valproic acid or iodine deficiency during pregnancy. Challenges to prevention efforts are reviewed. The aim of this review is to bring to the forefront the urgency of birth defects prevention, surveillance, and prenatal screening and counseling; and to help public health practitioners develop population-based birth defects surveillance and prevention programs, and policy-makers to develop and implement science-based public health policies.
Industry and government institutions need a credible approach for evaluating and responding to em... more Industry and government institutions need a credible approach for evaluating and responding to emerging public health issues. Representatives of industry, government, and academia met under the auspices of the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) to develop successful strategies for dealing with emerging issues based on historical case studies. The case studies chosen for evaluation were (1) tampon use and toxic shock syndrome; (2) hazardous waste and childhood cancer risk in Toms River, New Jersey; (3) fenfluramine and phentermine use and valvular heart disease; (4) silicone breast implants and cancer and auto-immune disease; and (5) progestational drugs and birth defects. We identified eight lessons from these case studies. Foremost, we recommend that public and private institutions not defer action until an issue is scientifically resolved and stress that cooperation among issue stakeholders is critical for effective issue resolution. We suggest establishing a research program as an effective way to assure that good science is included in resolution of the issue. We further recommend frequent and timely communication with all stakeholders, and the development of research approaches to fill gaps when the scientific data on an issue are limited.
... that child bed fever (puerperal fever) was a contagious disease that could be markedly reduce... more ... that child bed fever (puerperal fever) was a contagious disease that could be markedly reduced by having the physicians wash their hands ... Godfrey P. Oakley, Jr, MD, MSPM Department of Epidemiology Rollins School of Public Health of Emory University Atlanta, GA 30322 ...
Data Revues 00029378 Unassign S0002937814010631, Jul 11, 2014
were utilized to analyze the frequency of certain perinatal risk factors that were associated wit... more were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP.
Planned home birth is a paradigmatic case study of the importance of ethics and professionalism i... more Planned home birth is a paradigmatic case study of the importance of ethics and professionalism in contemporary perinatology. In this article we provide a summary of recent analyses of the Centers for Disease Control database on attendants and birth outcomes in the United States. This summary documents the increased risks of neonatal mortality and morbidity of planned home birth as well as bias in Apgar scoring. We then describe the professional responsibility model of obstetric ethics, which is based on the professional medical ethics of two major figures in the history of medical ethics, Drs. John Gregory of Scotland and Thomas Percival of England. This model emphasizes the identification and careful balancing of the perinatologist's ethical obligations to pregnant, fetal, and neonatal patients. This model stands in sharp contrast to one-dimensional maternal-rights-based reductionist model of obstetric ethics, which is based solely on the pregnant woman's rights. We then identify the implications of the professional responsibility model for the perinatologist's role in directive counseling of women who express an interest in or ask about planned home birth. Perinatologists should explain the evidence of the increased, preventable perinatal risks of planned home birth, recommend against it, and recommend planned hospital birth. Perinatologists have the professional responsibility to create and sustain a strong culture of safety committed to a home-birth-like experience in the hospital. By routinely fulfilling these professional responsibilities perinatologists can help to prevent the documented, increased risks planned home birth.
American journal of obstetrics and gynecology, 2015
We analyzed the perinatal risks of midwife-attended planned home births in the United States from... more We analyzed the perinatal risks of midwife-attended planned home births in the United States from 2010 through 2012 and compared them with recommendations from the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) for planned home births. Data from the US Centers for Disease Control and Prevention's National Center for Health Statistics birth certificate data files from 2010 through 2012 were utilized to analyze the frequency of certain perinatal risk factors that were associated with planned midwife-attended home births in the United States and compare them with deliveries performed in the hospital by certified nurse midwives. Home birth deliveries attended by others were excluded; only planned home births attended by midwives were included. Hospital deliveries attended by certified nurse midwives served as the reference. Perinatal risk factors were those established by ACOG and AAP. Midwife-attended planned home births in t...
Background: The Apgar score is used worldwide to assess the newborn infant shortly after birth. A... more Background: The Apgar score is used worldwide to assess the newborn infant shortly after birth. Apgar scores, including mean scores and those with high cut-off scores, have been used to support claims that planned home birth is as safe as hospital birth. The purpose of this study was to determine the distribution of 5 min Apgar scores among different birth settings and providers in the USA. Methods: We obtained data from the National Center for Health Statistics of the US Centers for Disease Control birth certificate data for 2007-2010 for all singleton, term births of infants weighing ≥2500 g (n=13,830,531). Patients were then grouped into six categories by birth setting and birth attendant: hospital-based physician, hospital-based midwife, freestanding birth center with either certified nurse midwife and/or other midwife, and home-based delivery with either certified nurse midwife or other midwife. The distribution of each Apgar score from 0 to 10 was assessed for each group. Resu...
ABSTRACT Data from 103 litters of albino rats were analyzed for the effects of the number of fetu... more ABSTRACT Data from 103 litters of albino rats were analyzed for the effects of the number of fetuses in the litter and in each uterine horn, resorptions, and intra-uterine position on variations in fetal weight. The right uterine horn tended to contain more fetuses than the left. There ...
ABSTRACT This study was conducted to determine if there is a greater variation in fetal weight an... more ABSTRACT This study was conducted to determine if there is a greater variation in fetal weight and/or placental weight among litters of rat fetuses than within a single litter. Three hundred and twenty-seven litters comprising 1,979 fetal and placental weights were analyzed using ...
Assessing the risk profiles of potentially sensitive populations requires a ''tool chest'' of met... more Assessing the risk profiles of potentially sensitive populations requires a ''tool chest'' of methodological approaches to adequately characterize and evaluate these populations. At present, there is an extensive body of literature on methodologies that apply to the evaluation of the pediatric population. The Health and Environmental Sciences Institute Subcommittee on Risk Assessment of Sensitive Populations evaluated key references in the area of pediatric risk to identify a spectrum of methodological approaches. These approaches are considered in this article for their potential to be extrapolated for the identification and assessment of other sensitive populations. Recommendations as to future research needs and/or alternate methodological considerations are also made.
There is significant public concern about the potential health effects of exposure to mercury vap... more There is significant public concern about the potential health effects of exposure to mercury vapour (Hg(0)) released from dental amalgam restorations. The purpose of this article is to provide information about the toxicokinetics of Hg(0), evaluate the findings from the recent scientific and medical literature, and identify research gaps that when filled may definitively support or refute the hypothesis that dental amalgam causes adverse health effects. Dental amalgam is a widely used restorative dental material that was introduced over 150 years ago. Most standard dental amalgam formulations contain approximately 50% elemental mercury. Experimental evidence consistently demonstrates that Hg(0) is released from dental amalgam restorations and is absorbed by the human body. Numerous studies report positive correlations between the number of dental amalgam restorations or surfaces and urine mercury concentrations in non-occupationally exposed individuals. Although of public concern, it is currently unclear what adverse health effects are caused by the levels of Hg(0) released from this restoration material. Historically, studies of occupationally exposed individuals have provided consistent information about the relationship between exposure to Hg(0) and adverse effects reflecting both nervous system and renal dysfunction. Workers are usually exposed to substantially higher Hg(0) levels than individuals with dental amalgam restorations and are typically exposed 8 hours per day for 20-30 years, whereas persons with dental amalgam restorations are exposed 24 hours per day over some portion of a lifetime. This review has uncovered no convincing evidence pointing to any adverse health effects that are attributable to dental amalgam restorations besides hypersensitivity in some individuals.
a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected ... more a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet standards of evidence-based reasoning, makes undocumented claims, treats as settled matters what are, instead, ongoing controversies, offers "mere opinion" as a substitute for argument, and makes contradictory claims. The Letter of Concern is a case study in unethical transgressive bioethics. We call on fetaldex.org to withdraw the letter and for co-signatories to withdraw their approval of it.
Birth defects are an urgent global health priority. They affect millions of births worldwide. But... more Birth defects are an urgent global health priority. They affect millions of births worldwide. But their prevalence and impact are largely under-ascertained, particularly in middle- and low-income countries. Fortunately, a large proportion of birth defects can be prevented. This review examines the global prevalence and primary prevention methods for major preventable birth defects: congenital rubella syndrome, folic acid-preventable spina bifida and anencephaly, fetal alcohol syndrome, Down syndrome, rhesus hemolytic disease of the fetus and the newborn; and those associated with maternal diabetes, and maternal exposure to valproic acid or iodine deficiency during pregnancy. Challenges to prevention efforts are reviewed. The aim of this review is to bring to the forefront the urgency of birth defects prevention, surveillance, and prenatal screening and counseling; and to help public health practitioners develop population-based birth defects surveillance and prevention programs, and policy-makers to develop and implement science-based public health policies.
Industry and government institutions need a credible approach for evaluating and responding to em... more Industry and government institutions need a credible approach for evaluating and responding to emerging public health issues. Representatives of industry, government, and academia met under the auspices of the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) to develop successful strategies for dealing with emerging issues based on historical case studies. The case studies chosen for evaluation were (1) tampon use and toxic shock syndrome; (2) hazardous waste and childhood cancer risk in Toms River, New Jersey; (3) fenfluramine and phentermine use and valvular heart disease; (4) silicone breast implants and cancer and auto-immune disease; and (5) progestational drugs and birth defects. We identified eight lessons from these case studies. Foremost, we recommend that public and private institutions not defer action until an issue is scientifically resolved and stress that cooperation among issue stakeholders is critical for effective issue resolution. We suggest establishing a research program as an effective way to assure that good science is included in resolution of the issue. We further recommend frequent and timely communication with all stakeholders, and the development of research approaches to fill gaps when the scientific data on an issue are limited.
... that child bed fever (puerperal fever) was a contagious disease that could be markedly reduce... more ... that child bed fever (puerperal fever) was a contagious disease that could be markedly reduced by having the physicians wash their hands ... Godfrey P. Oakley, Jr, MD, MSPM Department of Epidemiology Rollins School of Public Health of Emory University Atlanta, GA 30322 ...
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