Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons.

BACKGROUND: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.

Birth Outcomes Among People with Hepatitis C in Pregnancy - Three U.S. States, 2018-2021.

INTRODUCTION: There are limited and conflicting data regarding the impact of hepatitis C in pregnancy on adverse birth outcomes. METHODS: Using the Surveillance for Emerging Threats to Pregnant People and Infants Network (SET-NET), a large surveillance cohort, we describe birth outcomes among a cohort of people with HCV in pregnancy in total and by reported substance use. RESULTS: Among 1418 infants, 89% were born to people with reported substance use during pregnancy. The proportion born preterm was 20%, 13% were small-for-gestational age and 34% of term infants required intensive care. CONCLUSIONS: Assessments of recent changes to recommendations for HCV screening in pregnancy should evaluate the impact on maternal access to care for both HCV treatment as well as comorbidities such as substance use disorder which may contribute to adverse birth outcomes.

Alcohol Use, Screening, and Brief Intervention Among Pregnant Persons - 24 U.S. Jurisdictions, 2017 and 2019.

Alcohol use during pregnancy is a major preventable cause of adverse alcohol-related outcomes, including birth defects and developmental disabilities.* Alcohol screening and brief intervention (ASBI) is an evidence-based primary care tool that has been shown to prevent or reduce alcohol consumption during pregnancy; interventions have resulted in an increase in the proportion of pregnant women reporting abstinence (odds ratio = 2.26; 95% CI = 1.43-3.56) (1). Previous national estimates have not characterized ASBI in populations of pregnant persons. Using 2017 and 2019 Behavioral Risk Factor Surveillance System (BRFSS) data, CDC examined prevalence of ASBI and characteristics of pregnant persons and nonpregnant women aged 18-49 years (reproductive-aged women) residing in jurisdictions that participated in the BRFSS ASBI module. During their most recent health care visit within the past 2 years, approximately 80% of pregnant persons reported being asked about their alcohol use; however, only 16% of pregnant persons who self-reported current drinking at the time of the survey (at least one alcoholic beverage in the past 30 days) were advised by a health care provider to quit drinking or reduce their alcohol use. Further, the prevalence of screening among pregnant persons who did not graduate from high school was lower than that among those who did graduate from high school or had at least some college education. This gap between screening and brief intervention, along with disparities in screening based on educational level, indicate missed opportunities to reduce alcohol use during pregnancy. Strategies to enhance ASBI during pregnancy include integrating screenings into electronic health records, increasing reimbursement for ASBI services, developing additional tools, including electronic ASBI, that can be implemented in a variety of settings (2,3).

Systematic Review: Polysubstance Prevalence Estimates Reported during Pregnancy, US, 2009-2020.

INTRODUCTION: The objective of this systematic review is to describe polysubstance studies and their prevalence estimates among pregnant people in the US. METHODS: This review was not subject to protocol preparation or registration with the International Prospective Register of Systematic Reviews (PROSPERO) because outcome data were not reported. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Checklist was followed. Four scientific literature databases were used to identify articles published from January 1, 2009 to June 3, 2020 reporting prenatal exposure to two or more substances in the US. A standardized process of title and abstract screening followed by a two-phase full-text review was used to assess study eligibility. RESULTS: A total of 119 studies were included: 7 case-control studies, 7 clinical trials, 76 cohort studies, and 29 cross-sectional studies. Studies varied with respect to study design, time period, region, sampling and participant selection, substances assessed, and method of exposure ascertainment. Commonly reported polysubstance prevalence estimates among studies of pregnant people included combinations with alcohol, marijuana, and/or tobacco/nicotine. The range of prevalence estimates was wide (alcohol 1-99%; marijuana 3-95%; tobacco/nicotine 2-95%). DISCUSSION: Polysubstance use during pregnancy is common, especially with alcohol, marijuana, and/or tobacco/nicotine. Future research to assess polysubstance use during pregnancy could help better describe patterns and ultimately help mitigate its effects on maternal and infant health outcomes.

Screening and Brief Interventions for Alcohol Use During Pregnancy: Practices Among US Primary Care Clinicians, DocStyles 2019.

INTRODUCTION: Alcohol use during pregnancy can cause birth defects and developmental disabilities. From 2018 through 2020, 13.5% of pregnant women reported current drinking. The US Preventive Services Task Force recommends evidence-based tools (eg, AUDIT-C and SASQ) for implementing screening and brief interventions to reduce excessive alcohol use among adults, including pregnant people, for whom any alcohol use is considered excessive. METHODS: We used DocStyles 2019 data to conduct a cross-sectional analysis to examine current screening and brief intervention practices that primary care clinicians conduct among pregnant patients; clinicians' confidence levels in conducting screening, brief interventions, and referral to treatment; and the documentation of brief interventions in the medical record. RESULTS: A total of 1,500 US adult medicine clinicians completed the entire survey. Among the respondents who conduct screening (N = 1,373) and brief interventions (N = 1,357) in their practice, nearly all reported implementing screening (94.6%) and brief interventions (94.9%) with their pregnant patients for alcohol use, but fewer than half felt confident about conducting their screening practices (46.5%). Two-thirds (64%) reported using a tool that met the criteria recommended by the US Preventive Services Task Force (USPSTF). Over half documented brief interventions in electronic health record notes (51.7%) or designated space (50.7%). CONCLUSION: Pregnancy presents a unique opportunity for clinicians to incorporate screening into routine obstetric care and encourage behavior change among patients. Most providers reported always screening their pregnant patients for alcohol use, but fewer used evidence-based USPSTF-recommended screening tools. Increased clinician confidence in screening and brief intervention, the use of standardized screening tools tailored to pregnant people, and maximal use of electronic health record technology may enhance the benefits of their application to alcohol use, which ultimately can reduce adverse outcomes associated with alcohol use during pregnancy.

Alcohol Consumption and Binge Drinking During Pregnancy Among Adults Aged 18-49 Years - United States, 2018-2020.

There is no known safe amount of alcohol consumption during pregnancy; drinking alcohol during pregnancy can cause fetal alcohol spectrum disorders and might increase the risk for miscarriage and stillbirth (1). The prevalence of drinking among pregnant women increased slightly during 2011-2018; however, more recent estimates are not yet reported (2). CDC estimated the prevalence of self-reported current drinking (at least one alcoholic drink in the past 30 days) and binge drinking (consuming four or more drinks on at least one occasion in the past 30 days) among pregnant adults aged 18-49 years, overall and by selected characteristics, using 2018-2020 Behavioral Risk Factor Surveillance System (BRFSS) data. During 2018-2020, 13.5% of pregnant adults reported current drinking and 5.2% reported binge drinking: both measures were 2 percentage points higher than during 2015-2017. Pregnant adults with frequent mental distress were 2.3 and 3.4 times as likely to report current and binge drinking, respectively, compared with those without frequent mental distress. In addition, pregnant adults without a usual health care provider were 1.7 times as likely to report current drinking as were those with a current provider. Alcohol consumption during pregnancy continues to be a serious problem. Integration of mental health services into clinical care and improving access to care might help address alcohol consumption and mental distress during pregnancy to prevent associated adverse outcomes (3).

Longitudinal changes in glucose metabolism in women with gestational diabetes, from late pregnancy to the postpartum period.

AIMS/HYPOTHESIS: This study aimed to determine, in women with gestational diabetes (GDM), the changes in insulin sensitivity (Matsuda Insulin Sensitivity Index; ISOGTT), insulin response and disposition index (DI) from late pregnancy (34-37 weeks gestation, T1), to early postpartum (1-5 days, T2) and late postpartum (6-12 weeks, T3). A secondary aim was to correlate the longitudinal changes in maternal lipids, adipokines, cytokines and weight in relation to the changes in ISOGTT, insulin response and DI. METHODS: ISOGTT, insulin response and DI were calculated at the three time points (T1, T2 and T3) using the results of a 75 g OGTT. Adipokines, cytokines and lipids were measured prior to each OGTT. Linear mixed-effects models were used to compare changes across each time point. Changes in ISOGTT, insulin response and DI were correlated with changes in maternal adipokines, cytokines and lipids at each time point. RESULTS: A total of 27 women completed all assessments. Compared with T1, ISOGTT was 11.20 (95% CI 8.09, 14.31) units higher at 1-5 days postpartum (p < 0.001) and was 5.49 (95% CI 2.38, 8.60) units higher at 6-12 weeks postpartum (p < 0.001). Compared with T1, insulin response values were 699.6 (95% CI 957.5, 441.6) units lower at T2 (p < 0.001) and were 356.3 (95% CI 614.3, 98.3) units lower at T3 (p = 0.004). Compared with T1, the DI was 6434.1 (95% CI 2486.2, 10,381.0) units higher at T2 (p = 0.001) and was 4262.0 (95% CI 314.6, 8209.3) units higher at T3 (p = 0.03). There was a decrease in mean cholesterol, triacylglycerol, LDL-cholesterol and VLDL-cholesterol from T1 to T2 (all p < 0.001), and an increase in mean C-reactive protein, IL-6 and IL-8 from T1 to T2 (all p < 0.001). Mean leptin decreased from T1 to T2 (p = 0.001). There was no significant change in mean adiponectin (p = 0.99) or TNF-α (p = 0.81) from T1 to T2. The mean maternal BMI decreased from T1 to T2 (p = 0.001) and T3 (p < 0.001). There were no significant correlations between any measure of change in ISOGTT, insulin response and DI and change in maternal cytokines, adipokines, lipids or weight from T1 to T2. CONCLUSIONS/INTERPRETATION: In women with GDM, delivery was associated with improvement in both insulin sensitivity and insulin production within the first few days. Improvement in insulin production persisted for 6-12 weeks, but insulin sensitivity deteriorated slightly. These changes in glucose metabolism were not associated to changes in lipids, leptin, inflammation markers or body weight. TRIAL REGISTRATION: ClinicalTrials.gov NCT02082301.

Should women with gestational diabetes be screened at delivery hospitalization for type 2 diabetes?

BACKGROUND: Less than one-half of women with gestational diabetes mellitus are screened for type 2 diabetes postpartum. Other approaches to postpartum screening need to be evaluated, including the role of screening during the delivery hospitalization. OBJECTIVE: To assess the performance of an oral glucose tolerance test administered during the delivery hospitalization compared with the oral glucose tolerance test administered at a 4- to 12-week postpartum visit. STUDY DESIGN: We conducted a combined analysis of patient-level data from 4 centers (6 clinical sites) assessing the utility of an immediate postpartum 75-g oral glucose tolerance test during the delivery hospitalization (PP1) for the diagnosis of type 2 diabetes compared with a routine 4- to 12-week postpartum oral glucose tolerance test (PP2). Eligible women underwent a 75-g oral glucose tolerance test at both PP1 and PP2. Sensitivity, specificity, and negative and positive predictive values of the PP1 test were estimated for diagnosis of type 2 diabetes, impaired fasting glucose, or impaired glucose tolerance. RESULTS: In total, 319 women completed a PP1 screening, with 152 (47.6%) lost to follow-up for the PP2 oral glucose tolerance test. None of the women with a normal PP1 oral glucose tolerance test (n=73) later tested as having type 2 diabetes at PP2. Overall, 12.6% of subjects (n=21) had a change from normal to impaired fasting glucose/impaired glucose tolerance or a change from impaired fasting glucose/impaired glucose tolerance to type 2 diabetes. The PP1 oral glucose tolerance test had 50% sensitivity (11.8-88.2), 95.7% specificity (91.3-98.2%) with a 98.1% (94.5-99.6%) negative predictive value and a 30% (95% confidence interval, 6.7-65.3) positive predictive value for type 2 diabetes vs normal/impaired fasting glucose/impaired glucose tolerance result. The negative predictive value of having type 2 diabetes at PP2 compared with a normal oral glucose tolerance test (excluding impaired fasting glucose/impaired glucose tolerance) at PP1 was 100% (95% confidence interval, 93.5-100) with a specificity of 96.5% (95% confidence interval, 87.9-99.6). CONCLUSION: A normal oral glucose tolerance test during the delivery hospitalization appears to exclude postpartum type 2 diabetes mellitus. However, the results of the immediate postpartum oral glucose tolerance test were mixed when including impaired fasting glucose or impaired glucose tolerance. As a majority of women do not return for postpartum diabetic screening, an oral glucose tolerance test during the delivery hospitalization may be of use in certain circumstances in which postpartum follow-up is challenging and resources could be focused on women with an abnormal screening immediately after the delivery hospitalization.

Specific birth defects in pregnancies of women with diabetes: National Birth Defects Prevention Study, 1997-2011.

BACKGROUND: Diabetes is associated with an increased risk for many birth defects and is likely to have an increasing impact on birth defect prevalence because of the rise in diabetes in the United States in recent decades. One of the first analyses in which specific birth defects were assessed for their relationship with both pregestational and gestational diabetes used data from the initial 6 years of the National Birth Defects Prevention Study. That analysis reported strong associations for pregestational diabetes with several birth defects, but few exposures among some of the less common birth defects led to unstable estimates with wide confidence intervals. Since that analysis, the study continued to collect data for another 8 years, including information on approximately 19,000 additional cases and 6900 additional controls. OBJECTIVE: Our objective was to use data from the National Birth Defects Prevention Study, the largest population-based birth defects case-control study in the United States, to provide updated and more precise estimates of the association between diabetes and birth defects, including some defects not previously assessed. STUDY DESIGN: We analyzed data on deliveries from October 1997 through December 2011. Mothers of case and control infants were interviewed about their health conditions and exposures during pregnancy, including diagnosis of pregestational (type 1 or type 2) diabetes before the index pregnancy or gestational diabetes during the index pregnancy. Using logistic regression, we separately assessed the association between pregestational and gestational diabetes with specific categories of structural birth defects for which there were at least 3 exposed case infants. For birth defect categories for which there were at least 5 exposed case infants, we calculated odds ratios adjusted for maternal body mass index, age, education, race/ethnicity, and study site; for defect categories with 3 or 4 exposed cases, we calculated crude odds ratios. RESULTS: Pregestational diabetes was reported by 0.6% of mothers of control infants (71 of 11,447) and 2.5% of mothers of case infants (775 of 31,007). Gestational diabetes during the index pregnancy was reported by 4.7% of mothers of control infants (536 of 11,447) and 5.3% of mothers of case infants (1,653 of 31,007). Pregestational diabetes was associated with strong, statistically significant odds ratios (range, 2.5-80.2) for 46 of 50 birth defects considered. The largest odds ratio was observed for sacral agenesis (adjusted odds ratio, 80.2; 95% confidence interval, 46.1-139.3). A greater than 10-fold increased risk was also observed for holoprosencephaly (adjusted odds ratio, 13.1; 95% confidence interval, 7.0-24.5), longitudinal limb deficiency (adjusted odds ratio, 10.1; 95% confidence interval, 6.2-16.5), heterotaxy (adjusted odds ratio, 12.3; 95% confidence interval, 7.3-20.5), truncus arteriosus (adjusted odds ratio, 14.9; 95% confidence interval, 7.6-29.3), atrioventricular septal defect (adjusted odds ratio, 10.5; 95% confidence interval, 6.2-17.9), and single ventricle complex (adjusted odds ratio, 14.7; 95% confidence interval, 8.9-24.3). For gestational diabetes, statistically significant odds ratios were fewer (12 of 56) and of smaller magnitude (range, 1.3- 2.1; 0.5 for gastroschisis). CONCLUSION: Pregestational diabetes is associated with a markedly increased risk for many specific births defects. Because glycemic control before pregnancy is associated with a reduced risk for birth defects, ongoing quality care for persons with diabetes is an important opportunity for prevention.

Alcohol Use and Co-Use of Other Substances Among Pregnant Females Aged 12-44 Years - United States, 2015-2018.

Drinking alcohol during pregnancy can cause fetal alcohol spectrum disorders, including birth defects, behavioral disorders, and impaired cognitive development (1). Little is known about the co-use of other substances by females who drink during pregnancy. CDC used 2015-2018 data from the National Survey on Drug Use and Health (NSDUH) to estimate the overall and trimester-specific prevalence of self-reported drinking in the past 12 months, current drinking, and binge drinking, overall and by trimester, and the co-use of other substances among pregnant females aged 12-44 years. Past drinking (12 months) was reported by 64.7% of pregnant respondents. Current drinking (at least one drink in the past 30 days) was reported by 19.6% of respondents who were in their first trimester of pregnancy and 4.7% of respondents who were in their second or third trimester. Binge drinking (consuming four or more drinks on at least one occasion in the past 30 days) was reported by 10.5% of first trimester respondents and 1.4% of second or third trimester respondents. Overall, 38.2% of pregnant respondents who reported current drinking also reported current use of one or more other substances. The substances used most with alcohol were tobacco and marijuana. Self-reported drinking prevalence was substantially lower among second or third trimester respondents than among first trimester respondents. The American College of Obstetricians and Gynecologists (ACOG) recommends alcohol use and substance use disorders screening for all females seeking obstetric-gynecologic care and counseling patients that there is no known safe level of alcohol use during pregnancy (2).

Physical Activity Before and During Pregnancy, Colorado Pregnancy Risk Assessment Monitoring System, 2012-2015.

We used 2012-2015 data from the Colorado Pregnancy Risk Assessment Monitoring System to describe changes in self-reported physical activity (PA) before and during pregnancy and used logistic regression to examine factors associated with regular PA. The prevalence of regular PA (ie, 30 or more minutes per day on 5 or more days per week) was 19.1% before pregnancy and decreased to 10.2% during pregnancy. At both times, adjusted odds of regular PA were lower among women who were overweight or had obesity before pregnancy than among those with normal weight. Findings suggest that most women with a recent live birth in Colorado, particularly those who are overweight or have obesity, are not obtaining many health benefits of PA either before or during pregnancy.

Consumption of Alcohol Beverages and Binge Drinking Among Pregnant Women Aged 18-44 Years - United States, 2015-2017.

Drinking alcohol during pregnancy can cause fetal alcohol spectrum disorders (FASDs), including birth defects that involve central nervous system impairment, behavioral disorders, and impaired intellectual development, which can lead to difficulties with school and employment. A recent study in four U.S. communities found a 1.1%-5.0% prevalence of FASDs among first-grade students (1). Drinking during pregnancy might also be a risk factor for other adverse pregnancy and birth outcomes, including miscarriage and stillbirth (2). CDC estimated the prevalence of self-reported current drinking (at least one alcohol drink in the past 30 days) and binge drinking (consuming four or more drinks on at least one occasion in the past 30 days) among pregnant women aged 18-44 years, using 2015-2017 data from the Behavioral Risk Factor Surveillance System (BRFSS). Current drinking and binge drinking in the past 30 days were reported by 11.5% and 3.9% of pregnant women, respectively. Among pregnant women who binge drink, the average frequency of binge drinking in the past 30 days was 4.5 episodes, and the average intensity of binge drinking (the average largest number of drinks reported consumed on any occasion among binge drinkers) was 6.0 drinks. Increased implementation of evidence-based community-level and clinic-level interventions, such as universal alcohol screening and brief counseling in primary and prenatal care, could decrease the prevalence of drinking during pregnancy, which might ultimately reduce the prevalence of FASDs and other adverse pregnancy and birth outcomes.

Gestational Weight Loss: Comparison Between the Birth Certificate and the Medical Record, Florida, 2012.

Objective Examine agreement with the medical record (MR) when gestational weight loss (GWL) on the Florida birth certificate (BC) is ≥ 0 pounds (lbs). Methods In 2012, 3923 Florida-resident women had a live, singleton birth where BC indicated GWL ≥ 0 lbs. Of these, we selected a stratified random sample of 2141 and abstracted from the MR prepregnancy and delivery weight data used to compute four estimates of GWL (delivery minus prepregnancy weight) from different sources found within the MR (first prenatal visit record, nursing admission record, labor/delivery records, BC worksheet). We assessed agreement between the BC and MR estimates for GWL categorized as 0, 1-10, 11-19, and ≥ 20 lbs. Results Prepregnancy or delivery weight was missing or source not in the MR for 23-81% of records. Overall agreement on GWL between the BC and the four MR estimates ranged from 39.1 to 57.2%. Agreement by GWL category ranged from 10.6 to 38.0% for 0 lbs, 47.6 to 64.3% for 1-10 lbs, 49.5 to 60.0% for 11-19 lbs, and 47.8 to 67.7% for ≥ 20 lbs. Conclusions Prepregnancy and delivery weight were frequently missing from the MR or inconsistently documented across the different sources. When the BC indicated GWL ≥ 0 lbs, agreement with different sources of the MR was moderate to poor revealing the need to reduce missing data and better understand the quality of weight data in the MR.

Hypertension and Diabetes in Non-Pregnant Women of Reproductive Age in the United States.

INTRODUCTION: Diagnosis and control of chronic conditions have implications for women's health and are major contributing factors to maternal and infant morbidity and mortality. This study estimated the prevalence of hypertension and diabetes in non-pregnant women of reproductive age in the United States, the proportion who were unaware of their condition or whose condition was not controlled, and differences in the prevalence of these conditions by selected characteristics. METHODS: We used data from the 2011-2016 National Health and Nutrition Examination Survey to estimate overall prevalence of hypertension and diabetes among women of reproductive age (aged 20-44 y), the proportion who were unaware of having hypertension or diabetes, and the proportion whose diabetes or hypertension was not controlled. We used logistic regression models to calculate adjusted prevalence ratios to assess differences by selected characteristics. RESULTS: The estimated prevalence of hypertension was 9.3% overall. Among those with hypertension, 16.9% were unaware of their hypertension status and 40.7% had uncontrolled hypertension. Among women with diabetes, almost 30% had undiagnosed diabetes, and among those with diagnosed diabetes, the condition was not controlled in 51.5%. CONCLUSION: This analysis improves our understanding of the prevalence of hypertension and diabetes among women of reproductive age and may facilitate opportunities to improve awareness and control of these conditions, reduce disparities in women's health, and improve birth outcomes.

Prevalence and Changes in Preexisting Diabetes and Gestational Diabetes Among Women Who Had a Live Birth - United States, 2012-2016.

Diabetes during pregnancy increases the risk for adverse maternal and infant health outcomes. Type 1 or type 2 diabetes diagnosed before pregnancy (preexisting diabetes) increases infants' risk for congenital anomalies, stillbirth, and being large for gestational age (1). Diabetes that develops and is diagnosed during the second half of pregnancy (gestational diabetes) increases infants' risk for being large for gestational age (1) and might increase the risk for childhood obesity (2); for mothers, gestational diabetes increases the risk for future type 2 diabetes (3). In the United States, prevalence of both preexisting and gestational diabetes increased from 2000 to 2010 (4,5). Recent state-specific trends have not been reported; therefore, CDC analyzed 2012-2016 National Vital Statistics System (NVSS) birth data. In 2016, the crude national prevalence of preexisting diabetes among women with live births was 0.9%, and prevalence of gestational diabetes was 6.0%. Among 40 jurisdictions with continuously available data from 2012 through 2016, the age- and race/ethnicity-standardized prevalence of preexisting diabetes was stable at 0.8% and increased slightly from 5.2% to 5.6% for gestational diabetes. Preconception care and lifestyle interventions before, during, and after pregnancy might provide opportunities to control, prevent, or mitigate health risks associated with diabetes during pregnancy.

Clinical, Hormonal, and Genetic Evaluation of Idiopathic Nonobstructive Azoospermia and Klinefelter Syndrome Patients.

To investigate the clinical, hormonal, and genetic factors in infertile men with idiopathic nonobstructive azoospermia (NOA) or azoospermic Klinefelter syndrome (KFS), a total of 556 and 96 patients, respectively, were included in this study. All patient samples were analyzed cytogenetically. Serum reproductive hormone levels were measured. Microdeletions in the azoospermia factor (AZF) region of the Y chromosome were detected by multiplex PCR using 16 specific sequence-tagged sites. FSH and LH levels in both NOA and KFS patients were significantly higher than the normal range, and the testosterone level in KFS patients was significantly lower. Ninety-two (95.8%) of the KFS patients showed non-mosaic 47,XXY karyotypes and 47,XXY,inv(9)(p11.1q13); the other KFS patients had mosaic karyotypes of 47,XXY/46,XY, 47,XXY/46,XX, and 47,XXY/48,XXXY/46,XX. Among the 556 idiopathic NOA patients with normal karyotypes, 67 (12.05%) had microdeletions in the AZF region of the Y chromosome. Microdeletions were most frequently detected in the AZFc region, followed by AZFa, AZFb, AZFbc, and partial AZFc deletions. However, Y chromosome microdeletions were not found in any of the azoospermic KFS patients. In view of the hormonal and genetic abnormalities in infertile men with idiopathic NOA and with azoospermic KFS, genetic testing for karyotype, Y chromosome microdeletions, and hormonal parameters is advocated.

Preventing large birth size in women with preexisting diabetes mellitus: The benefit of appropriate gestational weight gain.

OBJECTIVE: To estimate the percentage of infants with large birth size attributable to excess gestational weight gain (GWG), independent of prepregnancy body mass index, among mothers with preexisting diabetes mellitus (PDM). STUDY DESIGN: We analyzed 2004-2008 Florida linked birth certificate and maternal hospital discharge data of live, term (37-41weeks) singleton deliveries (N=641,857). We calculated prevalence of large-for-gestational age (LGA) (birth weight-for-gestational age≥90th percentile) and macrosomia (birth weight>4500g) by GWG categories (inadequate, appropriate, or excess). We used multivariable logistic regression to estimate the relative risk (RR) of large birth size associated with excess compared to appropriate GWG among mothers with PDM. We then estimated the population attributable fraction (PAF) of large birth size due to excess GWG among mothers with PDM (n=4427). RESULTS: Regardless of diabetes status, half of mothers (51.2%) gained weight in excess of recommendations. Large birth size was higher in infants of mothers with PDM than in infants of mothers without diabetes (28.8% versus 9.4% for LGA, 5.8% versus 0.9% for macrosomia). Among women with PDM, the adjusted RR of having an LGA infant was 1.7 (95% CI 1.5, 1.9) for women with excess GWG compared to those with appropriate gain; the PAF was 27.7% (95% CI 22.0, 33.3). For macrosomia, the adjusted RR associated with excess GWG was 2.1 (95% CI 1.5, 2.9) and the PAF was 38.6% (95% CI 24.9, 52.4). CONCLUSION: Preventing excess GWG may avert over one-third of macrosomic term infants of mothers with PDM. Effective strategies to prevent excess GWG are needed.

Are Birth Certificate and Hospital Discharge Linkages Performed in 52 Jurisdictions in the United States?

OBJECTIVES: The purpose of this study was to determine the number and characteristics of US State Registrars of Vital Statistics (Vital Registrars) and State Systems Development Initiative (SSDI) Coordinators that link birth certificate and hospital discharge data as well as using linkage processes. METHODS: Vital Registrars and SSDI Coordinators in all 52 vital records jurisdictions (50 states, District of Columbia, and New York City) were asked to complete a 41-question survey. We examined frequency distributions among completed surveys using SAS 9.3. RESULTS: The response rate was 100% (N = 52) for Vital Registrars and 96% (N = 50) for SSDI Coordinators. Nearly half of Vital Registrars (n = 22) and SSDI Coordinators (n = 23) reported that their jurisdiction linked birth certificate and hospital discharge records at least once in the last 4 years. Among those who link, the majority of Vital Registrars (77.3%) and SSDI Coordinators (82.6) link both maternal and infant hospital discharge records to the birth certificate. Of those who do not link, 43% of the Vital Registrars and 55% of SSDI Coordinators reported an interest in linking birth certificate and hospital discharge data. Reasons for not linking included lack of staff time, inability to access raw data, high cost, and unavailability of personal identifiers to link the two sources. CONCLUSIONS: Results of our analysis provide a national perspective on data linkage practices in the US. Our findings can be used to promote further data linkages, facilitate sharing of data and linkage methodologies, and identify uses of the resulting linked data.

Estimating the Recurrence Rate of Gestational Diabetes Mellitus (GDM) in Massachusetts 1998-2007: Methods and Findings.

OBJECTIVES: Women with gestational diabetes mellitus (GDM) may be able to reduce their risk of recurrent GDM and progression to type 2 diabetes mellitus through lifestyle change; however, there is limited population-based information on GDM recurrence rates. METHODS: We used data from a population of women delivering two sequential live singleton infants in Massachusetts (1998-2007) to estimate the prevalence of chronic diabetes mellitus (CDM) and GDM in parity one pregnancies and recurrence of GDM and progression from GDM to CDM in parity two pregnancies. We examined four diabetes classification approaches; birth certificate (BC) data alone, hospital discharge (HD) data alone, both sources hierarchically combined with a diagnosis of CDM from either source taking priority over a diagnosis of GDM, and both sources combined including only pregnancies with full agreement in diagnosis. Descriptive statistics were used to describe population characteristics, prevalence of CDM and GDM, and recurrence of diabetes in successive pregnancies. Diabetes classification agreement was assessed using the Kappa statistic. Associated maternal characteristics were examined through adjusted model-based t tests and Chi square tests. RESULTS: A total of 134,670 women with two sequential deliveries of parities one and two were identified. While there was only slight agreement on GDM classification across HD and BC records, estimates of GDM recurrence were fairly consistent; nearly half of women with GDM in their parity one pregnancy developed GDM in their subsequent pregnancy. While estimates of progression from GDM to CDM across sequential pregnancies were more variable, all approaches yielded estimates of ≤5 %. The development of either GDM or CDM following a parity one pregnancy with no diagnosis of diabetes was <3 % across approaches. Women with recurrent GDM were disproportionately older and foreign born. CONCLUSION: Recurrent GDM is a serious life course public health issue; the inter-pregnancy interval provides an important window for diabetes prevention.