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Background: Bipolar radiofrequency (RF) ablation strategies are increasingly used, mainly to target deep myocardial reentrant circuits responsible for ventricular tachycardia that cannot be extinguished with traditional unipolar RF ablation. Because this strategy is novel, factors that affect lesion geometry and steam pop formation require further investigation. Objective: To assess the effect of contact force, power, and time on the resulting lesion geometry and the risk of steam pop formation during bipolar RF ablation of thick myocardial tissue. Methods: A custom ex vivo bipolar ablation model was used to assess lesion formation. A combination of parallel and perpendicular configurations of ablation catheters was used to create lesions by varying force (20g, 30g, or 40g), power (30 or 40 W), and time (20, 30, 45, or 60 seconds). Lesion dimensions and the incidence of steam pops were recorded and then analyzed with binary logistic regression and multiple linear regression. Results: In bipolar ablation, lesion transmurality was most affected by the amount of time RF energy was applied. Durations longer than 20 seconds resulted in lesions deeper than half the tissue thickness. Steam pop formation was more frequent in thinner tissue, at longer ablation times, and at higher powers. Conclusion: The parameters assessed in this ex vivo model could be used as guidelines for future in vivo work and clinical evaluation of interventricular septal bipolar ablation.

Sexual size dimorphism is thought to contribute to the greater mortality and morbidity of men compared with women. However, the timing of onset of sexual size dimorphism remains uncertain. The authors determined whether human fetuses exhibit sexual size dimorphism in the first trimester of pregnancy. Using a prospective cohort study, conducted in 1999-2002 in the United States, they identified 27,655 women who conceived spontaneously and 1,008 whose conception was assisted by in vitro fertilization or intrauterine insemination and for whom a first-trimester measurement of fetal crown-rump length was available. First-trimester size was expressed as the difference between the observed and expected size of the fetus, expressed as equivalence to days of gestational age. The authors evaluated the association between fetal sex, first-trimester size, and birth weight. Eight to 12 weeks after conception, males were larger than females (mean difference: assisted conception = 0.4 days, 95% confidence interval (CI): 0.1, 0.7, p = 0.008; spontaneous conception = 0.3 days, 95% CI: 0.2, 0.4, p < 0.00001). The size discrepancy remained significant at birth (mean birth weight difference: assisted conception = 90 g, 95% CI: 22, 159, p = 0.009; spontaneous conception = 120 g, 95% CI: 107, 132, p < 0.00001). These data demonstrate that human fetuses exhibit sexual size dimorphism in the first trimester of pregnancy. [ABSTRACT FROM AUTHOR]

Background: While medications for anxiety and depression are commonly used in the United States, it is unclear to what degree they are continued during pregnancy. Methods: We used a large administrative database to determine whether psychiatric medications are continued during pregnancy and predictors of continued medication treatment. Results: Of 2,672,656 women included in our analysis, 86,454 (3.1%) filled a pre-pregnancy prescription for an anxiolytic or antidepressant medication within 3 months of estimated conception. Of women who filled a pre-pregnancy prescription, 49.4%, 26.1%, and 20.1% filled subsequent prescriptions in the 1st, 2nd, and 3rd trimesters. Discontinuation rates ranged by pharmaceutical agent, from 16% for fluoxetine to 71% for alprazolam. White women and women over 25 were more likely to continue anxiolytic and antidepressant treatment during pregnancy. Conclusion: Because untreated and under-treated mental health conditions are linked to adverse maternal outcomes, high discontinuation rates may have important implications for maternal health.

Importance: Reducing rates of unnecessary cesarean deliveries is both a national and a global health objective. However, there are limited national US data on trends in indications for low-risk cesarean delivery., Objective: To determine temporal trends in and indications for cesarean delivery among patients at low risk for the procedure over a 20-year period., Design, Setting, and Participants: This cross-sectional study analyzed 2000 to 2019 delivery hospitalizations using the National Inpatient Sample. Births at low risk for cesarean delivery were identified using a definition from the Society for Maternal-Fetal Medicine and additional criteria. Temporal trends in cesarean birth were analyzed using joinpoint regression to estimate the average annual percentage change (AAPC) with 95% CIs. Data analysis was performed from August 2022 to January 2023., Exposure: This analysis evaluated cesarean birth trends in a population at low risk for this procedure over a 20-year period., Main Outcomes and Measures: In addition to overall cesarean birth risk, cesarean deliveries for nonreassuring fetal status and labor arrest were individually analyzed., Results: Of an estimated 76.7 million delivery hospitalizations, 21.5 million were excluded according to the Society for Maternal-Fetal Medicine definition, and 14.7 million were excluded according to additional criteria. Of the estimated 40 517 867 deliveries included, 12.1% (4 885 716 deliveries) were by cesarean delivery. Cesarean deliveries among patients at low risk for the procedure increased from 9.7% to 13.9% between 2000 and 2009, plateaued, and then decreased from 13.0% to 11.1% between 2012 and 2019. The AAPC for cesarean delivery was 6.4% (95% CI, 5.2% to 7.6%) from 2000 to 2005, 1.2% from 2005 to 2009 (95% CI, -1.2% to 3.7%), and -2.2% from 2009 to 2019 (95% CI, -2.7% to -1.8%). Cesarean delivery for nonreassuring fetal status increased from 3.4% of all deliveries in 2000 to 5.1% in 2019 (AAPC, 2.1%; 95% CI, 1.7% to 2.5%). Cesarean delivery for labor arrest increased from 3.6% in 2000 to a peak of 4.8% in 2009 before decreasing to 2.7% in 2019. Cesarean deliveries for labor arrest increased during the first half of the study (2000-2009) for the active phase (from 1.5% to 2.1%), latent phase (from 1.1% to 1.5%), and second stage (from 0.9% to 1.3%) and then decreased from 2010 to 2019, from 2.1% to 1.7% for the active phase, from 1.5% to 1.2% for the latent phase, and from 1.2% to 0.9% for the second stage., Conclusions and Relevance: Cesarean deliveries among patients at low risk for cesarean birth appeared to decrease over the latter years of the study period, with cesarean deliveries for labor arrest becoming less common.

Importance: The associations of B vitamin status with metabolic syndrome (MetS) incidence among the US population remain unclear., Objective: To investigate intakes and serum concentrations of folate, vitamin B6, and vitamin B12 in association with MetS risk in a large US cohort., Design, Setting, and Participants: This prospective study included Black and White young adults in the US who were enrolled from 1985 to 1986 and studied until 2015 to 2016. Diet was assessed using a validated diet history at examination years 0, 7, and 20. Serum concentrations of folate, vitamin B6, and vitamin B12 were assayed at examination years 0, 7, and 15 in a subset of 1430 participants. MetS was ascertained by clinic and laboratory measurements and self-reported medication use. Data were analyzed between January and July 2021., Exposures: Intakes and serum levels of folate, vitamin B6, and vitamin B12., Main Outcomes and Measures: Multivariable Cox proportional hazards regression models were used to calculate hazard ratios (HRs) and 95% CIs for the associations of energy-adjusted B vitamin intakes or serum B vitamin levels with incident MetS., Results: The study included 4414 participants, with 2225 Black individuals (50.4%) and 2331 women (52.8%). The mean (SD) age at baseline was 24.9 (3.6) years. A total of 1240 incident MetS cases occurred during the 30 years (mean [SD], 22.1 [9.5] years) of follow-up. Compared with the lowest quintile of each energy-adjusted B vitamin intake, the HRs for incident MetS in the highest quintile were 0.39 (95% CI, 0.31-0.49) for folate (P for trend < .001), 0.61 (95% CI, 0.46-0.81) for vitamin B6 (P for trend = .002), and 0.74 (95% CI, 0.58-0.95) for vitamin B12 (P for trend = .008) after adjustment for potential confounders. Similarly, significant inverse associations were observed in the subset with serum data on these B vitamins (folate: HR, 0.23; 95% CI, 0.17-0.33; P for trend < .001; vitamin B6: HR, 0.48; 95% CI, 0.34-0.67; P for trend < .001; and vitamin B12: HR, 0.70; 95% CI, 0.51-0.96; P for trend = .01)., Conclusions and Relevance: This prospective cohort study found that intakes and serum concentrations of folate, vitamin B6, and vitamin B12 were inversely associated with incident MetS among Black and White young adults in the US.

Introduction: We examined the associations of baseline telomere length (TL) and TL change with cognitive function over time in older US adults, as well as differences by sex and race., Methods: A total of 1820 cognitively healthy individuals (median baseline age: 63 years) were included. Telomere length was measured using qPCR-based method at baseline and among 614 participants in the follow-up examination 10 years later. Cognitive function was assessed by a four-test battery every 2 years., Results: In multivariable-adjusted linear mixed models, longer baseline TL and smaller attrition/lengthening of TL over time were associated with better Animal Fluency Test score. Longer baseline TL was also linearly associated with better Letter Fluency Test score. The observed associations were consistently more pronounced in women than men and in Black compared to White participants., Discussion: Telomere length may be a biomarker that predicts long-term verbal fluency and executive function, particularly in women and Black Americans.

Context: Interpretation of thyroid function tests during pregnancy is limited by the generalizability of reference intervals between cohorts due to inconsistent methodology., Objective: (1) To provide an overview of published reference intervals for thyrotropin (TSH) and free thyroxine (FT4) in pregnancy, (2) to assess the consequences of common methodological between-study differences by combining raw data from different cohorts., Methods: (1) Ovid MEDLINE, EMBASE, and Web of Science were searched until December 12, 2021. Studies were assessed in duplicate. (2) The individual participant data (IPD) meta-analysis was performed in participating cohorts in the Consortium on Thyroid and Pregnancy., Results: (1) Large between-study methodological differences were identified, 11 of 102 included studies were in accordance with current guidelines; (2) 22 cohorts involving 63 198 participants were included in the meta-analysis. Not excluding thyroid peroxidase antibody-positive participants led to a rise in the upper limits of TSH in all cohorts, especially in the first (mean +17.4%; range +1.6 to +30.3%) and second trimester (mean +9.8%; range +0.6 to +32.3%). The use of the 95th percentile led to considerable changes in upper limits, varying from -10.8% to -21.8% for TSH and -1.2% to -13.2% for FT4. All other additional exclusion criteria changed reference interval cut-offs by a maximum of 3.5%. Applying these findings to the 102 studies included in the systematic review, 48 studies could be used in a clinical setting., Conclusion: We provide an overview of clinically relevant reference intervals for TSH and FT4 in pregnancy. The results of the meta-analysis indicate that future studies can adopt a simplified study setup without additional exclusion criteria., (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.)

Background: Previous studies on long-chain n-3 polyunsaturated fatty acids (LCn3PUFAs) and infant neurodevelopment did not consider effect modifications of mercury (Hg) and selenium (Se)., Objectives: To examine the joint association of prenatal LCn3PUFAs, Hg and Se with infant cognitive performance, and to explore whether DNA methylation may explain this potential association., Methods: A total of 484 newborns were enrolled from the Shanghai Birth Cohort with available data on cord blood LCn3PUFA, nail Hg and Se during 2015-2016. Cord blood LCn3PUFA concentrations were assessed by gas chromatography, and nail Hg and Se concentrations were measured using clippings collected within 6 months of birth by inductively coupled plasma mass spectrometry. Five aspects of infant neurodevelopment (communication, gross motor, fine motor, problem-solving, and personal-social skills) were assessed using the Age and Stage Questionnaire (ASQ) at ages 6 and 12 months. Multivariable-adjusted generalized estimating equations models were performed to examine the associations between cord blood LCn3PUFA concentrations and ASQ test scores, and these associations were stratified by nail Hg and Se levels. Epigenome-wide DNA methylation in cord blood was compared in a random subgroup consisting of 19 infants from the highest and 21 from the lowest decile of LCn3PUFA concentrations., Results: LCn3PUFAs were not significantly associated with any ASQ test scores. However, in the subgroup with lower Hg (trend <0.01; P interaction  = 0.03]. Additionally, twenty CpG sites were differentially methylated when comparing high to low LCn3PUFA groups., Conclusion: The association of prenatal LCn3PUFA concentrations with infant neurodevelopment, particularly gross motor skills, may be observed among infants with high Se and low Hg levels., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Previous studies suggest that certain dietary patterns and constituents may be beneficial to brain health. Airborne exposures to fine particulate matter [particulate matter with aerodynamic diameter ≤ 2.5 μ m ( PM 2.5 )] are neurotoxic, but the combined effects of dietary patterns and PM 2.5 have not been investigated., Objectives: We examined whether previously reported association between PM 2.5 exposure and lower white matter volume (WMV) differed between women whose usual diet during the last 3 months before baseline was more or less consistent with a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND)-like diet, a dietary pattern that may slow neurodegenerative changes., Methods: This study included 1,302 U.S. women who were 65-79 y old and free of dementia in the period 1996-1998 (baseline). In the period 2005-2006, structural brain magnetic resonance imaging (MRI) scans were performed to estimate normal-appearing brain volumes (excluding areas with evidence of small vessel ischemic disease). Baseline MIND diet scores were derived from a food frequency questionnaire. Three-year average PM 2.5 exposure prior to MRI was estimated using geocoded participant addresses and a spatiotemporal model., Results: Average total and temporal lobe WMVs were 0.74   cm 3 [95% confidence interval (CI): 0.001, 1.48) and 0.19   cm 3 (95% CI: 0.002, 0.37) higher, respectively, with each 0.5-point increase in the MIND score and were 4.16   cm 3 (95% CI: - 6.99 , - 1.33 ) and 1.46   cm 3 (95% CI: - 2.16 , - 0.76 ) lower, respectively, with each interquartile range (IQR) ( IQR = 3.22   μ g / m 3 ) increase in PM 2.5 . The inverse association between PM 2.5 per IQR and WMV was stronger ( p -interaction < 0.001 ) among women with MIND scores below the median (for total WMV, - 12.47   cm 3 ; 95% CI: - 17.17 , - 7.78 ), but absent in women with scores above the median ( 0.16   cm 3 ; 95% CI: - 3.41 , 3.72), with similar patterns for WMV in the frontal, parietal, and temporal lobes. For total cerebral and hippocampus brain volumes or WMV in the corpus callosum, the associations with PM 2.5 were not significantly different for women with high MIND scores and women with low MIND scores., Discussion: In this cohort of U.S. women, PM 2.5 exposure was associated with lower MRI-based WMV, an indication of brain aging, only among women whose usual diet was less consistent with the MIND-like dietary pattern at baseline. https://doi.org/10.1289/EHP8036.

Objective: To evaluate the performance of first trimester combined screening for the detection of rare chromosomal abnormalities, other than Trisomies 21, 18 or 13 or 45 × ., Study Design: A database containing 36,254 pregnancies was analyzed. These patients were recruited at 15 US centers and included singleton pregnancies from 10 3/7-13 6/7 weeks. All patients had a nuchal translucency (NT) scan and those without a cystic hygroma (N = 36,120) underwent a combined first trimester screening test ('FTS' - NT, PAPP-A and fbHCG). A risk cut-off of 1:300, which was used for defining high risk for Trisomy 21, was also used to evaluate the detection rate for rare chromosomal abnormalities using the combined FTS test., Results: 36,120 patients underwent combined FTS. Of these, 123 were found to have one of the following chromosomal abnormalities: Trisomy 21, Trisomy 18, Trisomy 13 or Turner syndrome. This study focuses on 40 additional patients who were found to have 'other' rare chromosomal abnormalities such as triploidy, structural chromosomal abnormalities, sex chromosome abnormalities or unusual chromosomal abnormalities (e.g. 47XX + 16), giving an incidence of 1.1 in 1000 for these rare chromosomal abnormalities. Of these 40 pregnancies, only 2 (5%) had an NT measurement of ≥3 mm. The detection rate for combined FTS, using a risk cut-off of ≥1:300, was 35 % (14 of 40 cases). Therefore, 65 % of cases of rarer fetal chromosomal abnormalities had a 'normal' combined FTS risk (<1:300) and 95 % had a 'normal' NT (<3 mm)., Conclusion: Traditional FTS methods are unable to identify the vast majority of rare chromosomal abnormalities. Our data do not support the potential detection of rare fetal chromosomal abnormalities as a reason to favour nuchal translucency-based first trimester screening over NIPT., Competing Interests: The authors have no conflicts of interest to declare., (© 2021 The Author(s).)

Introduction: Cardiovascular and cerebrovascular diseases (CCVDs) are the leading cause of maternal mortality in the first year after delivery. Women whose pregnancies were complicated by pre-eclampsia are at particularly high risk for adverse events. In addition, women with a history of pre-eclampsia have higher risk of CCVD later in life. The physiological mechanisms that contribute to increased CCVD risk in these women are not well understood, and the optimal clinical pathways for postpartum CCVD risk reduction are not yet defined., Methods and Analysis: The Motherhealth Study (MHS) is a prospective cohort study at Columbia University Irving Medical Center (CUIMC), a quaternary care academic medical centre serving a multiethnic population in New York City. MHS began recruitment on 28 September 2018 and will enrol 60 women diagnosed with pre-eclampsia with severe features in the antepartum or postpartum period, and 40 normotensive pregnant women as a comparison cohort. Clinical data, biospecimens and measures of vascular function will be collected from all participants at the time of enrolment. Women in the pre-eclampsia group will complete an additional three postpartum study visits over 12-24 months. Visits will include additional detailed cardiovascular and cerebrovascular phenotyping. As this is an exploratory, observational pilot study, only descriptive statistics are planned. Data will be used to inform power calculations for future planned interventional studies., Ethics and Dissemination: The CUIMC Institutional Review Board approved this study prior to initiation of recruitment. All participants signed informed consent prior to enrolment. Results will be disseminated to the clinical and research community, along with the public, on completion of analyses. Data will be shared on reasonable request., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Accumulating evidence indicates that maternal diets are important for optimizing maternal and offspring health. Existing research lacks comprehensive profiles of maternal diets throughout pregnancy, especially in a racially/ethnically diverse obstetrical population., Objective: The aim was to characterize diets in a longitudinal US pregnancy cohort by trimester, race/ethnicity, and prepregnancy BMI., Methods: Data were obtained from pregnant women in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies-Singleton cohort (2009-2013). A food-frequency questionnaire (FFQ) at 8-13 wk of gestation assessed periconception and first-trimester diet ( n  = 1615). Automated, self-administered, 24-h dietary recalls targeted at 16-22, 24-29, 30-33, and 34-37 wk of gestation assessed second- and third-trimester diets ( n  = 1817 women/6791 recalls). The Healthy Eating Index-2010 (HEI-2010) assessed diet quality (i.e., adherence to US Dietary Guidelines). Variations in weighted energy-adjusted means for foods and nutrients were examined by trimester, self-identified race/ethnicity, and self-reported prepregnancy BMI., Results: Mean (95% CI) HEI-2010 was 65.9 (64.9, 67.0) during periconception to the first trimester assessed with an FFQ and 51.6 (50.8, 52.4) and 51.5 (50.7, 52.3) during the second trimester and third trimester, respectively, assessed using 24-h recalls. No significant differences were observed between the second and third trimester in macronutrients, micronutrients, foods, or HEI-2010 components ( P  ≥ 0.05). Periconception to first-trimester HEI-2010 was highest among Asian/Pacific Islander [67.2 (65.9, 68.6)] and lowest among non-Hispanic Black [58.7 (57.5, 60.0)] women and highest among women with normal weight [67.2 (66.1, 68.4)] and lowest among women with obesity [63.5 (62.1, 64.9)]. Similar rankings were observed in the second/third trimesters., Conclusions: Most pregnant women in this cohort reported dietary intakes that, on average, did not meet US Dietary Guidelines for nonpregnant individuals. Also, diet differed across race/ethnic groups and by prepregnancy BMI, with the lowest overall dietary quality in all trimesters among non-Hispanic Black women and women with obesity. No meaningful changes in dietary intake were observed between the second and third trimesters., (Published by Oxford University Press on behalf of the American Society for Nutrition 2020.)

Background: Cardio-obstetrics refers to a team-based approach to maternal care that includes multidisciplinary collaboration among maternal fetal medicine, cardiology, and others., Objectives: This study sought to describe clinical characteristics, maternal and fetal outcomes, and cardiovascular readmissions in a cohort of pregnant women with underlying cardiovascular disease (CVD) followed by a cardio-obstetrics team., Methods: We identified patients evaluated by our cardio-obstetrics team from January 1, 2010, through December 31, 2019, at a quaternary care hospital in New York City. Information was collected regarding demographics, comorbidities, underlying CVD, medications, maternal and fetal outcomes, and cardiovascular readmissions. Each patient was assigned a Cardiac Disease in Pregnancy (CARPREG) II score based on her clinical characteristics and underlying CVD., Results: During the study period, 306 pregnant women (median age 29 years, 52.9% Hispanic or Latino) with CVD were seen. Most women (74.2%) were insured through Medicaid. The most common forms of CVD included arrhythmia (n = 88, 28.8%), congenital heart disease (n = 72, 23.5%), and cardiomyopathy (n = 72, 23.5%). The median CARPREG II score was 3; 130 patients (42.5%) had a CARPREG II score ≥4. Gestational diabetes occurred in 11.4%, gestational hypertension in 9.5%, and preeclampsia in 12.1% of women. Intensive care unit admission was required for 27 patients (8.8%) during delivery. Median gestational age for delivery was 38 weeks (interquartile range: 37 to 39). Live birth occurred in 98% of pregnancies. One maternal death occurred within a year of delivery in a woman with Eisenmenger syndrome. Following delivery, 30-day readmission rate was 2% and the rate of readmission from 30 to 90 days postpartum was 4.6%. Median follow-up was 2.6 years., Conclusions: In a population of primarily Medicaid-insured pregnant women managed by a cardio-obstetrics team, maternal outcomes were encouraging and readmission rates following delivery were low. Prospective studies are needed to evaluate the impact of cardio-obstetric models of care on maternal outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Racial disparities contribute to maternal morbidity in the United States. Hypertension is associated with poor maternal outcomes, including stroke. Disparities in hypertension might contribute to maternal strokes. Methods and Results Using billing data from the Healthcare Cost and Utilization Project's National Inpatient Sample, we analyzed the effect of race/ethnicity on stroke during delivery admission in women aged 18 to 54 years delivering in US hospitals from January 1, 1998, through December 31, 2014. We categorized hypertension as normotensive, chronic hypertension, or pregnancy-induced hypertension. Adjusted risk ratios (aRRs) and 95% CIs were calculated using log-linear Poisson regression models, testing for interactions between race/ethnicity and hypertensive status. A total of 65 286 425 women were admitted for delivery during the study period, of whom 7764 were diagnosed with a stroke (11.9 per 100 000 deliveries). Hypertension modified the effect of race/ethnicity ( P <0.0001 for interaction). Among women with pregnancy-induced hypertension, black and Hispanic women had higher stroke risk compared with non-Hispanic whites (blacks: aRR, 2.07; 95% CI, 1.86-2.30; Hispanics: aRR, 2.19; 95% CI, 1.98-2.43). Among women with chronic hypertension, all minority women had higher stroke risk (blacks: aRR, 1.71; 95% CI, 1.30-2.26; Hispanics: aRR, 1.75; 95% CI, 2.32-5.63; Asian/Pacific Islanders: aRR, 3.62; 95% CI, 2.32-5.63). Among normotensive women, only blacks had increased stroke risk (aRR, 1.17; 95% CI, 1.07-1.28). Conclusions Pregnant US women from minority groups had higher stroke risk during delivery admissions, compared with non-Hispanic whites. The effect of race/ethnicity was larger in women with chronic hypertension or pregnancy-induced hypertension. Targeting blood pressure management in pregnancy may help reduce maternal stroke risk in minority populations.

Obstetric venous thromboembolism is a leading cause of severe maternal morbidity and mortality. Maternal death from thromboembolism is amenable to prevention, and thromboprophylaxis is the most readily implementable means of systematically reducing the maternal death rate. Observational data support the benefit of risk-factor-based prophylaxis in reducing obstetric thromboembolism. This bundle, developed by a multidisciplinary working group and published by the National Partnership for Maternal Safety under the guidance of the Council on Patient Safety in Women's Health Care, supports routine thromboembolism risk assessment for obstetric patients, with appropriate use of pharmacologic and mechanical thromboprophylaxis. Safety bundles outline critical clinical practices that should be implemented in every maternity unit. The safety bundle is organized into four domains: Readiness, Recognition, Response, and Reporting and Systems Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged.

The infant mortality rate (IMR) of 6.0 per 1000 live births in the United States in 2013 is nearly the highest among developed countries. Moreover, the IMR among blacks is >twice that among whites-11.11 versus 5.06 deaths per 1000 live births.This higher IMR and racial disparity in IMR is due to a higher preterm birth rate (11.4% of live births in 2013) and higher IMR among term infants. The United States also ranks near the bottom for maternal mortality and life expectancy among the developed nations-despite ranking highest in the proportion of gross national product spent on health care. This suggests that factors other than health care contribute to the higher IMR and racial disparity in IMR. One factor is disadvantaged socioeconomic status. All of the actionable determinates that negatively impact health-personal behavior, social factors, heath-care access and quality and the environment-disproportionately affect the poor. Addressing disadvantaged socioeconomic status by improving access to quality health care and increasing social expenditures would have the greatest impact on the USA's IMR and racial disparity in IMR.

Despite substantial research, the early diagnosis of preeclampsia remains elusive. Lipids are now recognized to be involved in regulation and pathophysiology of some disease. Shotgun lipidomic studies were undertaken to determine whether serum lipid biomarkers exist that predict preeclampsia later in the same in pregnancy. A discovery study was performed using sera collected at 12-14 weeks pregnancy from 27 controls with uncomplicated pregnancies and 29 cases that later developed preeclampsia. Lipids were extracted and analyzed by direct infusion into a TOF mass spectrometer. MS signals, demonstrating apparent differences were selected, their abundances determined, and statistical differences tested. Statistically significant lipid markers were reevaluated in a second confirmatory study having 43 controls and 37 preeclampsia cases. Multi-marker combinations were developed using those lipid biomarkers confirmed in the second study. The initial study detected 45 potential preeclampsia markers. Of these, 23 markers continued to be statistically significant in the second confirmatory set. Most of these markers, representing several lipid classes, were chemically characterized, typically providing lipid class and potential molecular components using MS(2) Several multi-marker panels with areas under the curve >0.85 and high predictive values were developed. Developed panels of serum lipidomic biomarkers appear to be able to identify most women at risk for preeclampsia in a given pregnancy at 12-14 weeks gestation., (Copyright © 2016 by the American Society for Biochemistry and Molecular Biology, Inc.)

Several studies have now reported associations between gestational diabetes mellitus (GDM) and low free thyroxine (fT4) during the second and third trimesters, but not in the first trimester. The present study further examines relationships between low fT4, maternal weight, and GDM among women in the FaSTER (First and Second Trimester Evaluation of Risk) trial, in an effort to determine the extent to which thyroid hormones might contribute to causality. The FaSTER cohort includes 9351 singleton, euthyroid women; 272 of these women were subsequently classified as having GDM. Thyrotropin (TSH), fT4, and thyroid antibodies were measured at 11-14 weeks' gestation (first trimester) and 15-18.9 weeks' gestation (second trimester). An earlier report of this cohort documented an inverse relationship between fT4 in the second trimester and maternal weight. In the current analysis, women with GDM were significantly older (32 vs. 28 years) and weighed more (75 vs. 64.5 kg). Maternal weight and age (but not TSH) were significantly associated univariately with fT4 (dependent variable), in the order listed. Second trimester fT4 odds ratios (OR) for GDM were 2.06 [95% CI 1.37-3.09] (unadjusted); and 1.89 [95% CI 1.26-2.84] (adjusted). First trimester odds ratios were not significant: OR 1.45 [95%CI 0.97-2.16] (unadjusted) and 1.11 [95% CI 0.74-1.62] (adjusted). The second trimester fT4/GDM relationship thus appeared to strengthen as gestation progressed. In FaSTER, high maternal weight was associated with both low fT4 and a higher GDM rate in the second trimester. Peripheral deiodinase activity is known to increase with high caloric intake (represented by high weight). We speculate that weight-related low fT4 (the metabolically inactive prohormone) is a marker for deiodinase activity, serving as a substrate for conversion of fT4 to free triiodothyronine (fT3), the active hormone responsible for glucose-related metabolic activity.

Fetomaternal hemorrhage (FMH) can be associated with significant perinatal mortality. Our review of the literature did not identify any cases of FMH following placement of an intrauterine pressure catheter (IUPC). In our case, an IUPC was inserted in a patient undergoing induction of labor at term. Fetal bradycardia ensued shortly after placement, warranting an emergent cesarean delivery. Severe neonatal anemia was identified, and evaluation of maternal blood was consistent with massive FMH. This is the first reported association between FMH and IUPC placement. If this relationship is validated in future reports, appropriate changes in clinical practice may be warranted.

Context: Lower birth weight has been reported in conjunction with high maternal free T4 (FT4) in euthyroid pregnancies, raising concerns for suboptimal outcomes., Objective: The objective of the study was to explore the relationships between high maternal FT4 and pregnancy complications in euthyroid women and to further examine the relationships among maternal size, FT4, and birth weight., Design: This was an observational multicenter cohort study., Setting: The study was conducted at prenatal clinics., Study Subjects: A total of 9209 euthyroid women with singleton pregnancies participated in the study., Interventions: There were no interventions., Main Outcome Measures: Relationships between second-trimester high maternal FT4 and pregnancy/delivery complications and, among FT4, maternal weight and birth weight were measured., Results: Women in the highest FT4 quintile are younger and weigh less than women in quintiles 1-4; gestational diabetes and preeclampsia occur less often (P = < .001, P < .001, P < .001, and P = .05, respectively). Lowest median birth weight occurs among women in the highest FT4 quintile (P = < .001), but deliveries less than 37 weeks' gestation are not increased. Labor/delivery complications do not differ by FT4 quintile. Restricting analyses to maternal weight-adjusted small-for-gestational-age deliveries yields similar results, except for preeclampsia. In the highest maternal weight decile, adjusted median birth weight is 266 g higher (8.3%) than in the lowest weight decile; adjusted median FT4 is 0.91 pmol/L lower (6.8%). Among women in the highest FT4 decile, adjusted median birth weight is 46 g lower (1.3%) than in the lowest FT4 decile. All three relationships are statistically significant (P < .001, P < .001, and P = .004, respectively)., Conclusions: Lower median birth weight among euthyroid women with high FT4 is not associated with adverse pregnancy outcomes. Further investigation is indicated to determine how the variations in thyroid hormone concentration influence birth weight.

Background: Previous studies have shown that woman's risk of breast cancer in later life is associated with her infants birth weights. The objective of this study was to determine if this association is independent of breast cancer risk factors, mother's own birth weight and to evaluate association between infants birth weight and hormonal environment during pregnancy. Independent association would have implications for understanding the mechanism, but also for prediction and prevention of breast cancer., Methods and Findings: Risk of breast cancer in relation to a first infant's birth weight, mother's own birth weight and breast cancer risk factors were evaluated in a prospective cohort of 410 women in the Framingham Study. Serum concentrations of estriol (E3), anti-estrogen alpha-fetoprotein (AFP), and pregnancy-associated plasma protein-A (PAPP-A) were measured in 23,824 pregnant women from a separate prospective cohort, the FASTER trial. During follow-up (median, 14 years) 31 women (7.6%) were diagnosed with breast cancer. Women with large birth weight infants (in the top quintile) had a higher breast cancer risk compared to other women (hazard ratio (HR), 2.5; 95% confidence interval (CI), 1.2-5.2; P = 0.012). The finding was not affected by adjustment for birth weight of the mother and traditional breast cancer risk factors (adjusted HR, 2.5; 95% CI, 1.2-5.6; P = 0.021). An infant's birth weight had a strong positive relationship with the mother's serum E3/AFP ratio and PAPP-A concentration during pregnancy. Adjustment for breast cancer risk factors did not have a material effect on these relationships., Conclusions: Giving birth to an infant with high birth weight was associated with increased breast cancer risk in later life, independently of mother's own birth weight and breast cancer risk factors and was also associated with a hormonal environment during pregnancy favoring future breast cancer development and progression.

Background: Low plasma folate concentrations in pregnancy are associated with preterm birth. Here we show an association between preconceptional folate supplementation and the risk of spontaneous preterm birth., Methods and Findings: In a cohort of 34,480 low-risk singleton pregnancies enrolled in a study of aneuploidy risk, preconceptional folate supplementation was prospectively recorded in the first trimester of pregnancy. Duration of pregnancy was estimated based on first trimester ultrasound examination. Natural length of pregnancy was defined as gestational age at delivery in pregnancies with no medical or obstetrical complications that may have constituted an indication for delivery. Spontaneous preterm birth was defined as duration of pregnancy between 20 and 37 wk without those complications. The association between preconceptional folate supplementation and the risk of spontaneous preterm birth was evaluated using survival analysis. Comparing to no supplementation, preconceptional folate supplementation for 1 y or longer was associated with a 70% decrease in the risk of spontaneous preterm delivery between 20 and 28 wk (41 [0.27%] versus 4 [0.04%] spontaneous preterm births, respectively; HR 0.22, 95% confidence interval [CI] 0.08-0.61, p = 0.004) and a 50% decrease in the risk of spontaneous preterm delivery between 28 and 32 wk (58 [0.38%] versus 12 [0.18%] preterm birth, respectively; HR 0.45, 95% CI 0.24-0.83, p = 0.010). Adjustment for maternal characteristics age, race, body mass index, education, marital status, smoking, parity, and history of prior preterm birth did not have a material effect on the association between folate supplementation for 1 y or longer and spontaneous preterm birth between 20 and 28, and 28 to 32 wk (adjusted HR 0.31, 95% CI 0.11-0.90, p = 0.031 and 0.53, 0.28-0.99, p = 0.046, respectively). Preconceptional folate supplementation was not significantly associated with the risk of spontaneous preterm birth beyond 32 wk. The association between shorter duration (<1 y) of preconceptional folate supplementation and the risk of spontaneous preterm birth was not significant after adjustment for maternal characteristics. However, the risk of spontaneous preterm birth decreased with the duration of preconceptional folate supplementation (test for trend of survivor functions, p = 0.01) and was the lowest in women who used folate supplementation for 1 y or longer. There was also no significant association with other complications of pregnancy studied after adjustment for maternal characteristics., Conclusions: Preconceptional folate supplementation is associated with a 50%-70% reduction in the incidence of early spontaneous preterm birth. The risk of early spontaneous preterm birth is inversely proportional to the duration of preconceptional folate supplementation. Preconceptional folate supplementation was specifically related to early spontaneous preterm birth and not associated with other complications of pregnancy.

Objective: To evaluate nuchal translucency measurement quality assurance techniques in a large-scale study., Methods: From 1999 to 2001, unselected patients with singleton gestations between 10 + 3 weeks and 13 + 6 weeks were recruited from 15 centers. Sonographic nuchal translucency measurement was performed by trained technicians. Four levels of quality assurance were employed: (1) a standardized protocol utilized by each sonographer; (2) local-image review by a second sonographer; (3) central-image scoring by a single physician; and (4) epidemiological monitoring of all accepted nuchal translucency measurements cross-sectionally and over time., Results: Detailed quality assessment was available for 37 018 patients. Nuchal translucency measurement was successful in 96.3% of women. Local reviewers rejected 0.8% of images, and the single central physician reviewer rejected a further 2.9%. Multivariate analysis indicated that higher body mass index, earlier gestational age and transvaginal probe use were predictors of failure of nuchal translucency measurement and central image rejection (P = 0.001). Epidemiological monitoring identified a drift in measurements over time., Conclusion: Despite initial training and continuous image review, changes in nuchal translucency measurements occur over time. To maintain screening accuracy, ongoing quality assessment is needed.

Objective: The objective of the study was to further explore relationships between human chorionic gonadotropin (hCG), TSH, and free T4 in pregnant women at 11 through 18 wk gestation., Study Design: The design of the study was to analyze hCG in comparison with TSH and free T4, in paired first- and second-trimester sera from 9562 women in the First and Second Trimester Evaluation of Risk for Fetal Aneuploidy trial study., Results: hCG is strongly correlated with body mass index, smoking, and gravidity. Correlations with selected maternal covariates also exist for TSH and free T4. As hCG deciles increase, body mass index and percent of women who smoke both decrease, whereas the percent of primigravid women increases (P < 0.0001). hCG/TSH correlations are weak in both trimesters (r2 = 0.03 and r2 = 0.02). TSH concentrations at the 25th and fifth centiles become sharply lower at higher hCG levels, whereas 50th centile and above TSH concentrations are only slightly lower. hCG/free T4 correlations are weak in both trimesters (r2 = 0.06 and r2 = 0.003). At 11-13 wk gestation, free T4 concentrations rise uniformly at all centiles, as hCG increases (test for trend, P < 0.0001), but not at 15-18 wk gestation. Multivariate analyses with TSH and free T4 as dependent variables and selected maternal covariates and hCG as independent variables do not alter these observations., Conclusions: In early pregnancy, a woman's centile TSH level appears to determine susceptibility to the TSH being suppressed at any given hCG level, suggesting that hCG itself may be the primary analyte responsible for stimulating the thyroid gland. hCG affects lower centile TSH values disproportionately.

Objective: To determine if first trimester fetal growth is associated with birth weight, duration of pregnancy, and the risk of delivering a small for gestational age infant., Design: Prospective cohort study of 38 033 pregnancies between 1999 and 2003., Setting: 15 centres representing major regions of the United States., Participants: 976 women from the original cohort who conceived as the result of assisted reproductive technology, had a first trimester ultrasound measurement of fetal crown-rump length, and delivered live singleton infants without evidence of chromosomal or congenital abnormalities. First trimester growth was expressed as the difference between the observed and expected size of the fetus, expressed as equivalence to days of gestational age., Main Outcome Measures: Birth weight, duration of pregnancy, and risk of delivering a small for gestational age infant., Results: For each one day increase in the observed size of the fetus, birth weight increased by 28.2 (95% confidence interval 14.6 to 41.2) g. The association was substantially attenuated by adjustment for duration of pregnancy (adjusted coefficient 17.1 (6.6 to 27.5) g). Further adjustments for maternal characteristics and complications of pregnancy did not have a significant effect. The risk of delivering a small for gestational age infant decreased with increasing size in the first trimester (odds ratio for a one day increase 0.87, 0.81 to 0.94). The association was not materially affected by adjustment for maternal characteristics or complications of pregnancy., Conclusion: Variation in birth weight may be determined, at least in part, by fetal growth in the first 12 weeks after conception through effects on timing of delivery and fetal growth velocity.

Objective: The purpose of this study was to describe the cost implications of converting an established videotape review network for obstetric ultrasonography to one based on telemedicine technology., Design: Retrospective review of fixed and non-fixed costs associated with interpreting obstetric ultrasound examinations using both videotape and telemedicine transmission., Subjects: A network of three community offices transmitting 600 obstetric ultrasound examinations per month to a central tertiary level facility., Methods: Sonographers at the community offices record ultrasound examinations onto videotape, which are then sent by courier to a central facility for interpretation. At the completion of this videotaped examination, sonographers repeat the ultrasound scan while transmitting real-time images over a telemedicine link to the central facility. Costs associated with the videotape review technique that can be avoided by converting to telemedicine interpretation were derived and compared with the fixed and non-fixed costs associated with establishing the telemedicine network., Results: For this network, the fixed costs for establishing telemedicine are $101,750. Monthly non-fixed cost savings by eliminating videotape review include $1620 to $2700 for printing still images, $1200 for courier charges and $7000 for fewer repeat ultrasound examinations. Monthly non-fixed costs for the telemedicine network are $2415. Net monthly savings in non-fixed costs for a telemedicine network are therefore $7405 to $8585, which may pay for the initial fixed costs in 12 to 14 months., Conclusions: The high cost of a telemedicine network may be offset by possible savings in non-fixed costs compared with alternative systems for interpreting obstetric ultrasonography.

There are no published guidelines on how to assess fetal well-being during hemodialysis. We have developed a specific protocol of renal and obstetric interventions to ensure that hemodialysis is associated with minimal changes in fetal status. We tested this protocol serially over a 9-week period in a pregnant patient who was undergoing chronic hemodialysis for end-stage renal disease. Testing involved serial assessments of uterine and umbilical artery blood flow with Doppler velocimetry and continuous fetal heart rate tracings, before, during and after each hemodialysis session. We found that, by strict adherence to these guidelines, there were no significant alterations in maternal mean arterial blood pressure, continuous fetal heart rate tracings, uterine artery systolic/diastolic ratios, or umbilical artery systolic/diastolic ratios. We conclude that stable uteroplacental and fetal perfusion can be maintained during chronic hemodialysis in pregnancy by adhering to a specific set of precautions.

Since its introduction in the 1950s, ultrasonography in pregnancy has been helpful in determining gestational age, detecting multiple pregnancies, locating placentas, diagnosing fetal anomalies, evaluating fetal well-being, and guiding obstetricians with in utero treatment. We review current standards and controversies regarding the indications, safety, accuracy, and limitations of ultrasonography in pregnancy.

Objectives: Our objectives were to characterize by transesophageal echocardiography the normal appearance of the Starr-Edwards prosthetic heart valve and to compare the utility of transesophageal and transthoracic echocardiography in detection of valve abnormality., Background: The Starr-Edwards prosthetic heart valve, the first mechanical valve to be used, has demonstrated excellent durability., Methods: Fifty transthoracic and transesophageal echocardiographic studies on 37 patients with 47 Starr-Edwards prosthetic valves were analyzed retrospectively. Six cases of surgically confirmed infective endocarditis were studied., Results: Vegetation or abscess formation, or both, was identified by transesophageal echocardiography in all six cases of infective endocarditis but was found in only one of these cases by transthoracic echocardiography. Thrombus was detected by transesophageal echocardiography in 9 of 11 patients with transient ischemic attacks or stroke and in 2 patients by transthoracic echocardiography with 3 confirmed at surgery. In 26 of the 30 patients with a mitral Starr-Edwards valve, the valve demonstrated a trivial or mild "closing volume" early systolic or holosystolic leak on transesophageal echocardiography alone. Transthoracic evaluation identified significant mitral regurgitation in six of the eight patients who had this finding on transesophageal echocardiography. Serial studies were performed to assess response to treatment or need for surgical intervention in eight patients. Seventeen valves have been implanted for 12 years; six of these had significant leakage without apparent cause, a finding not observed more recently implanted valves., Conclusions: These observations demonstrated the unique utility of transesophageal echocardiography in patients with Starr-Edwards prosthetic valve dysfunction, endocarditis or thrombus formation, and of the clear superiority of transesophageal echocardiography over transthoracic echocardiography in these situations.