Use of electronic health record best practice alerts to improve adherence to American Urological Association vesicoureteral reflux guidelines.

PURPOSE: To evaluate the effect of a guidelines-based best practice alerts (BPA) in the electronic health record (EHR) on adherence to American Urological Association (AUA) vesicoureteral reflux (VUR) guidelines. METHODS: Retrospective cohort study of patients aged 0-17 years old with primary VUR with an initial urology clinic visit the year before or year after BPA implementation was done. Primary outcomes include obtaining vital signs, urinalysis, and ultrasound at initial and 1-year follow-up visit. RESULTS: We identified 123 patients with initial visits during the study period, 58 of whom returned for 1-year follow-up visits. Patients seen post-BPA were more likely to have height measured at initial visit than those seen pre-BPA (47.3% vs. 11.8%, p < 0.001). The majority of patients were screened with weight (98.3%) and ultrasound (87.9%) at 1-year follow-up both before and after BPA implementation. Neither blood pressure measurements (59.1% vs. 55.6%, p > 0.5) nor urinalysis orders (23.8% vs. 19.4%, p > 0.05) significantly increased post-BPA. CONCLUSION: The use of an EHR-based BPA increased the likelihood of obtaining height measurements by clinic intake staff but did not significantly affect provider adherence to other practice guideline recommendations. Our findings suggest that BPA implementation alone is not sufficient to impact provider uptake of VUR guideline recommendations.

The role of preoperative instructions in parents' understanding of preoperative fasting for outpatient pediatric urology procedures.

PURPOSE: To assess the impact of modifications in preoperative instructions on parental understanding of preoperative fasting guidelines. METHODS: A prospective postoperative parental survey was conducted to assess parental understanding of preoperative fasting requirements in patients undergoing surgery before and after institution of instructions that included visual aids. Data regarding demographics, procedure type, and time to surgery from preoperative visit were also captured. Survey data were compared between pre- and post-intervention groups using Chi-squared tests for categorical variables and Wilcoxon rank sum test for continuous variables. RESULTS: 173 parents in the pre-intervention group and 162 parents in the post-intervention group were included in the analysis. Parent identification of aspiration risk as the reason for fasting almost doubled after intervention (72.2% vs. 38.2%). There was some evidence of demographic differences between groups; however, in an adjusted model, there was strong evidence (p < 0.001) that parents in the post-intervention group were more likely to identify aspiration as the reason for preoperative fasting (OR 4.73; 95% CI 2.93-7.63). CONCLUSIONS: Addition of visual aids in preoperative instructions was associated with improvement in parents' understanding of the rationale behind preoperative fasting instructions. Further studies are needed to determine whether improved understanding is associated with improved adherence.

Variations in Adherence to American Urological Association Guidelines for Followup of Children with Vesicoureteral Reflux.

INTRODUCTION: Although the American Urological Association has established clinical guidelines for evaluation of vesicoureteral reflux in children, adoption of these guidelines has not been measured. The purpose of this study was to assess adherence to American Urological Association recommendations for annual followup in a multicenter cohort of children with vesicoureteral reflux. METHODS: We conducted a retrospective cohort study utilizing data in the Epic electronic health record across 3 pediatric urology practices. Patients were included if they had an initial clinic visit between January 1, 2010 and December 31, 2016, were under the age of 11 years and had a diagnosis of vesicoureteral reflux. Data regarding patient demographics, initial and 1-year followup evaluation with vital signs, urinalysis and ultrasound were captured. Kruskal-Wallis and chi-square analyses were used for univariable analyses. Logistic regression models were created for multivariable analyses. RESULTS: We identified 1,576 patients. Most patients were female (68%), Hispanic or nonwhite (52%) and treated with antibiotic prophylaxis (55.7%). Initial evaluation with vital signs and urinalysis varied significantly across sites (p <0.05). In patients who had a 1-year followup visit (974) followup vital signs and urinalysis varied by site (p <0.001). Followup ultrasound did not vary by site. Using multivariate analysis, followup measures were associated with location and measures obtained at initial evaluation (p <0.05). Additionally, followup ultrasound and urinalysis were more likely in children on antibiotic prophylaxis (p <0.05). CONCLUSIONS: We found significant variations in adherence to American Urological Association recommendations for annual followup of children with vesicoureteral reflux. Further work is needed to understand the impact of these variations on patient outcomes.

Development and Validation of a Predictive Model of the Risk of Pediatric Septic Shock Using Data Known at the Time of Hospital Arrival.

OBJECTIVE: To derive and validate a model of risk of septic shock among children with suspected sepsis, using data known in the electronic health record at hospital arrival. STUDY DESIGN: This observational cohort study at 6 pediatric emergency department and urgent care sites used a training dataset (5 sites, April 1, 2013, to December 31, 2016), a temporal test set (5 sites, January 1, 2017 to June 30, 2018), and a geographic test set (a sixth site, April 1, 2013, to December 31, 2018). Patients 60 days to 18 years of age in whom clinicians suspected sepsis were included; patients with septic shock on arrival were excluded. The outcome, septic shock, was systolic hypotension with vasoactive medication or ≥30 mL/kg of isotonic crystalloid within 24 hours of arrival. Elastic net regularization, a penalized regression technique, was used to develop a model in the training set. RESULTS: Of 2464 included visits, septic shock occurred in 282 (11.4%). The model had an area under the curve of 0.79 (0.76-0.83) in the training set, 0.75 (0.69-0.81) in the temporal test set, and 0.87 (0.73-1.00) in the geographic test set. With a threshold set to 90% sensitivity in the training set, the model yielded 82% (72%-90%) sensitivity and 48% (44%-52%) specificity in the temporal test set, and 90% (55%-100%) sensitivity and 32% (21%-46%) specificity in the geographic test set. CONCLUSIONS: This model estimated the risk of septic shock in children at hospital arrival earlier than existing models. It leveraged the predictive value of routine electronic health record data through a modern predictive algorithm and has the potential to enhance clinical risk stratification in the critical moments before deterioration.

A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers.

OBJECTIVE: To update a previous assessment of birth defects among infants born to active duty U.S. military mothers who received the 2009-2010 pandemic H1N1 vaccine, in comparison to the 2008-2009 seasonal influenza vaccine, during pregnancy. Here, we updated the previous comparative analyses with a more refined definition for birth defects using an additional year of follow-up data from both inpatient and outpatient medical encounters. METHODS: The study population included 15,510 live born infants born to active duty mothers vaccinated during pregnancy with either the 2009-2010 pandemic H1N1 vaccine (n = 9033) or the 2008-2009 seasonal influenza vaccine (n = 6477). Birth defect cases were defined as those infants who received a birth defect diagnosis on one inpatient record or two outpatient records on different days within the first year of life. Multivariable logistic regression models were conducted to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) for the association between birth defects and maternal vaccination during pregnancy with pandemic H1N1 vaccine versus seasonal influenza vaccine. RESULTS: Infants born to mothers vaccinated during pregnancy with the pandemic H1N1 vaccine, versus the seasonal influenza vaccine, were not at increased odds of birth defects in univariable (OR: 1.13, 95% CI: 0.95-1.34) or multivariable (OR: 1.14, 95% CI: 0.96-1.35) models. Findings were not significant when further limited to first trimester exposure. Multivariable models were adjusted for infant sex and plurality; maternal age, race/ethnicity, marital status, service branch, military rank, and occupation; timing of vaccination; and receipt of vaccination(s) not routinely recommended during pregnancy. CONCLUSION: Comparable to our previous analyses assessing birth defects diagnosed at birth, no significant association was found between the pandemic H1N1 vaccination during pregnancy and birth defects, versus the seasonal influenza vaccine. These findings are reassuring and provide additional support for H1N1-containing seasonal influenza vaccination during pregnancy.

Safety of inadvertent anthrax vaccination during pregnancy: An analysis of birth defects in the U.S. military population, 2003-2010.

BACKGROUND: Anthrax vaccine adsorbed (AVA) vaccination is compulsory for United States military servicemembers with operational indicators. As the number of female military servicemembers has increased, so has the chance of inadvertent AVA vaccination during pregnancy. Building upon past analyses assessing AVA vaccination during pregnancy and birth defects risk, this study sought to determine if inadvertent AVA vaccination during pregnancy is significantly associated with risk of birth defects after adjusting for other potential risk factors. METHODS: The study population included 126,839 liveborn infants in the Department of Defense Birth and Infant Health Registry (2003-2010). Mothers were categorized by AVA vaccination exposure timing in relation to pregnancy. Infant medical records were assessed for birth defect diagnoses within the first year of life. Multivariable logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Infants of first trimester AVA vaccinated mothers versus receipt at any other time point (OR, 1.10; 95% CI, 0.93-1.29) were not at higher odds of birth defects in adjusted models. Infants of mothers vaccinated prepregnancy versus postpregnancy had a 1.11 (95% CI, 1.01-1.22) higher odds of having a birth defect. Vaccination postpregnancy versus never vaccinated revealed a 10% lower odds of birth defects (OR, 0.90; 95% CI, 0.83-0.99). CONCLUSIONS: No strong associations between inadvertent AVA vaccination during pregnancy and birth defects risk were observed. Marginal associations between prepregnancy vaccination or never vaccinated women and birth defects risk was observed when compared to postpregnancy vaccination. These findings may be due to self-selection and/or reverse causation bias when assessing comparisons with postpregnancy vaccination, and a "healthy worker" effect when assessing comparisons with women never vaccinated.

Risk Factors Associated with Miscarriage and Impaired Fecundity among United States Servicewomen during the Recent Conflicts in Iraq and Afghanistan.

BACKGROUND: Research on the reproductive health of U.S. servicewomen deployed in support of the recent operations in Iraq and Afghanistan is sparse. The objective of this study was to evaluate whether military experiences, including combat deployment, deployment length, and life stressors during the recent conflicts, were associated with increased odds for miscarriage or impaired fecundity among U.S. servicewomen. METHODS: We used data from the Millennium Cohort Study, a large longitudinal military study that began in 2001 and includes military personnel from all service branches, including active duty and Reserve/National Guard personnel. Participants for this study included women aged 18 to 45 years who had completed two questionnaires (2004-2006 and 2007-2008). Separate multivariable logistic regression models were performed to estimate the odds of reporting miscarriage and impaired fecundity by military experiences that adjusted for covariates. Subanalyses were conducted using International Classification of Diseases, Ninth Revision, Clinical Modification codes found in the Military Health System Data Repository for both outcomes among servicewomen on active duty. RESULTS: Overall, 31% and 11% of military servicewomen reported miscarriage and impaired fecundity, respectively, during the approximate 3-year follow-up period. After adjusting for demographic, behavioral, and military characteristics, deployment experiences and life stressors were not associated with miscarriage or perceived impaired fecundity. Subanalyses using medical record data confirmed these results. CONCLUSIONS: Overall, these results suggest that military deployments do not increase risk for miscarriage and impaired fecundity among U.S. servicewomen. However, because the point estimates for many of the exposures were elevated, more research is needed to better understand the potential risks associated with environmental exposures and specific types of combat exposures.

Postpartum depression and timing of spousal military deployment relative to pregnancy and delivery.

OBJECTIVE: This study aimed to determine the relationship between spousal deployment and postpartum depression diagnosis among U.S. military wives, accounting for the timing of deployment with respect to pregnancy and delivery. METHODS: A retrospective cohort study was conducted to evaluate the association between spousal deployment and postpartum depression among pregnant wives of active-duty service members. Electronic medical records for 161,454 births occurring between 2004 and 2009 were used to define postpartum depression. Three non-mutually exclusive exposure variables were created to categorize deployments as occurring before, during, or after the infant's delivery. A multivariable logistic regression model mutually adjusted for these exposure variables was fitted, producing an odds ratio for each of the three timing categories. RESULTS: A modest significant association was detected only in those whose husbands deployed in pregnancy and returned after delivery (i.e., deployed during delivery) [odds ratio (OR) 1.10, 95 % confidence interval (CI) 1.04-1.15]. An interactive effect between preexisting depression or anxiety and deployment during delivery was also detected in the data (OR 1.13, 95 % CI 1.07-1.20 for those without a preexisting diagnosis; OR 0.87, 95 % CI 0.80-0.95 for those with a preexisting diagnosis). CONCLUSION: Health care providers should continue to be aware of spousal deployment as a military-unique stressor in this population and rigorously screen for potential symptoms of postpartum depression, especially among those whose husbands are absent at delivery.

Greater risk of hospitalization in children with Down syndrome and OSA at higher elevation.

BACKGROUND: Children with Down syndrome (DS) are at high risk for OSA. Increasing elevation is known to exacerbate underlying respiratory disorders and worsen sleep quality in people without DS, but whether altitude modulates the severity of OSA in DS is uncertain. In this study, we evaluate the impact of elevation (≤ 1,500 m vs > 1,500 m) on the proportion of hospitalizations involving OSA in children with and without DS. METHODS: Merging the 2009 Kids' Inpatient Database with zip-code linked elevation data, we analyzed differences in the proportion of pediatric hospitalizations (ages 2-20 years) involving OSA, pneumonia, and congenital heart disease (CHD), with and without DS. We used multivariable logistic regression to evaluate the association of elevation with hospitalizations involving OSA and DS, adjusting for key comorbidities. RESULTS: Proportionately more DS encounters involved OSA, CHD, and pneumonia within each elevation category than non-DS encounters. However, the risk difference for hospitalizations involving OSA and DS increased disproportionately at higher elevations (DS: 16.2% [95% CI, 9.2%-23.2%]; non-DS: 0.1% [95% CI, -0.4% to 0.7%]). Multivariable estimates of relative risk indicate increased risk for hospitalization involving OSA at higher elevations for people with DS and in children aged 2 to 4 years or with two or more chronic conditions. CONCLUSIONS: At elevations > 1,500 m, children with DS and OSA have a disproportionately higher risk for hospitalization than children with OSA without DS. This finding has not been described previously. With further validation, this finding suggests the need for greater awareness and earlier screening for OSA and its complications in patients with DS living at higher elevations.

Infant abusive head trauma in a military cohort.

OBJECTIVE: Evaluate the rate of, and risk factors for, abusive head trauma (AHT) among infants born to military families and compare with civilian population rates. METHODS: Electronic International Classification of Diseases data from the US Department of Defense (DoD) Birth and Infant Health Registry were used to identify infants born to military families from 1998 through 2005 (N = 676 827) who met the study definition for AHT. DoD Family Advocacy Program data were used to identify infants with substantiated reports of abuse. Rates within the military were compared with civilian population rates by applying an alternate AHT case definition used in a civilian study. RESULTS: Applying the study definition, the estimated rate of substantiated military AHT was 34.0 cases in the first year of life per 100 000 live births. Using the alternate case definition, the estimated AHT rate was 25.6 cases per 100 000 live births. Infant risk factors for AHT included male sex, premature birth, and a diagnosed major birth defect. Parental risk factors included young maternal age (<21 years), lower sponsor rank or pay grade, and current maternal military service. CONCLUSIONS: This is the first large database study of AHT with the ability to link investigative results to cases. Overall rates of AHT were consistent with civilian populations when using the same case definition codes. Infants most at risk, warranting special attention from military family support programs, include infants with parents in lower military pay grades, infants with military mothers, and infants born premature or with birth defects.

Safety of the pandemic H1N1 influenza vaccine among pregnant U.S. military women and their newborns.

OBJECTIVES: To assess adverse pregnancy outcomes among active-duty U.S. military women who received pandemic H1N1 vaccine during pregnancy as well as adverse health outcomes among the newborns resulting from these pregnancies. METHODS: The primary study population was a retrospective cohort of active-duty U.S. military women vaccinated during pregnancy with either the pandemic H1N1 vaccine between October 2009 and June 2010 or with seasonal influenza vaccine between October 2008 and June 2009. Rates of pregnancy loss, preeclampsia or eclampsia, and preterm labor were compared between pandemic H1N1 vaccine-exposed (n=10,376) and seasonal influenza vaccine-exposed pregnancies (n=7,560). A secondary study population consisted of newborns resulting from these pregnancies. Rates of preterm birth, birth defects, fetal growth problems, and the male-to-female sex ratio were compared between newborns exposed to pandemic H1N1 vaccine and newborns exposed to seasonal influenza vaccine in utero. RESULTS: No significant differences were observed in rates of pregnancy loss (6.4% compared with 6.5%), preeclampsia or eclampsia (5.8% compared with 5.2%), or preterm labor (6.5% compared with 6.2%) between pandemic H1N1 vaccine-exposed and seasonal influenza vaccine-exposed pregnancies. Furthermore, no significant differences were observed in rates of preterm birth (6.2% compared with 6.3%), birth defects (2.1% compared with 2.0%), fetal growth problems (2.6% compared with 2.4%), or the male-to-female sex ratio (1.05 compared with 1.07) between newborns exposed in utero to pandemic H1N1 vaccine compared with seasonal influenza vaccine. Rates of all outcomes were lower or similar to overall general population rates. This study had at least 80% power to detect hazard ratios of 1.18-1.21 or odds ratios of 1.10-1.36, depending on outcome prevalence. CONCLUSION: No adverse pregnancy or newborn health outcomes associated with pandemic H1N1 vaccination during pregnancy were noted among our cohort. These findings should be used to encourage increased vaccine coverage among pregnant women.

Birth defects in infants born in 1998-2004 to men and women serving in the U.S. military during the 1990-1991 Gulf War era.

BACKGROUND: Concerns about reproductive health persist among U.S. military members who served in the 1990-1991 Gulf War. This study explores the long-term impact of 1990-1991 Gulf War deployment on the prevalence of birth defects among infants of Gulf War veterans. METHODS: Health care data from the Department of Defense Birth and Infant Health Registry and demographic and deployment information from the Defense Manpower Data Center were used to identify infants born between 1998 and 2004 to both male and female 1990-1991 Gulf War veterans. Multivariable logistic regression models estimated the adjusted odds of any birth defect and eight specific birth defects among infants of deployers versus non-deployers. In addition, birth defects were evaluated among infants born to 1990-1991 Gulf War veterans with deployment-specific exposures. RESULTS: Among 178,766 infants identified for these analyses, 3.4% were diagnosed with a birth defect in the first year of life. Compared to infants of non-deployers, infants of deployers were not at increased odds of being diagnosed with a birth defect, or any of eight specific birth defects, in the first year of life. A slightly increased prevalence of birth defects was observed among infants born to men who deployed to the 1990-1991 Gulf War for 153 to 200 days compared to those who deployed for 1 to 92 days. No other deployment-specific exposures were associated with birth defects in these infants. CONCLUSIONS: The 1990-1991 Gulf War deployers, including those with specific exposures of concern, were not found to be at increased risk for having infants with birth defects 7 to 14 years after deployment.

Birth outcomes among military personnel after exposure to documented open-air burn pits before and during pregnancy.

OBJECTIVE: To examine birth outcomes in military women and men with potential exposure to documented open-air burn pits before and during pregnancy. METHODS: Electronic data from the Department of Defense Birth and Infant Health Registry and the Defense Manpower Data Center were used to examine the prevalence of birth defects and preterm birth among infants of active-duty women and men who were deployed within a 3-mile radius of a documented open-air burn pit before or during pregnancy. RESULTS: In general, burn pit exposure at various times in relation to pregnancy and for differing durations was not consistently associated with an increase in birth defects or preterm birth in infants of active-duty military personnel. CONCLUSIONS: These analyses offer reassurance to service members that burn pit exposure is not consistently associated with these select adverse infant health outcomes.

Validating the use of ICD-9-CM codes to evaluate gestational age and birth weight.

BACKGROUND: Efforts to reduce preterm and low-weight births are among the leading public health objectives in the United States and the world. A necessary component of any public health endeavor is surveillance. The Department of Defense (DoD) Birth and Infant Health Registry (Registry) uses electronic healthcare utilization data to assess reproductive health outcomes among military families. Infant health outcomes are coded using the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). The objective of this study was to determine the accuracy of using electronically derived ICD-9-CM codes for assessing gestational age and birth weight among Registry infants compared to medical records. METHODS: The authors assessed birth outcome agreement by comparing electronic Registry data for infants born at military treatment facilities (MTFs) from 1999-2002 and 1,858 randomly selected birth medical records from 17 MTFs, with descriptive statistics and measures of agreement, including the kappa statistic. RESULTS: Of the 1,858 reviewed infant records, 1,669 were successfully matched to the Registry analytic dataset for analyses. Despite small differences in parental demographics, this investigation established "near perfect" agreement for the primary outcomes: kappa of 0.83 for preterm and 0.87 for low birth weight. Subgroup analyses revealed no significant differences in gestational age and birth-weight agreement based on the presence of a birth defect, military parent rank, branch of military service, or specific hospital characteristics. CONCLUSIONS: Electronically derived ICD-9-CM codes provide an accurate assessment of the gestational age and low birth weight reflected in the birth medical records of infants in a large birth and infant health registry. These findings support the integrity of Registry data for investigations assessing preterm and low-weight births among U.S. service member families.

Health outcomes among infants born to women deployed to United States military operations during pregnancy.

BACKGROUND: Military professionals who deploy to combat operations may encounter hazards that could adversely affect reproductive health. Pregnant women are generally exempt from deployment to military operations; however, exposures to such environments may inadvertently occur. We investigated whether maternal deployment during pregnancy was associated with adverse health outcomes in infants. METHODS: The United States Department of Defense Birth and Infant Health Registry identified infants born to military service women between 2002 and 2005, and defined their health outcomes at birth and in the first year of life. Multivariable modeling was applied to investigate preterm birth and birth defects among infants, based on maternal deployment experience during pregnancy. RESULTS: Among 63,056 infants born to military women from 2002 to 2005, 22,596 were born to women with deployment experience in support of the current military operations before, during, or after their pregnancy. These included 2941 infants born to women who appeared to have been deployed some time during their first trimester of pregnancy. Compared to infants born to women who deployed at other times, or never deployed, exposed infants were not more likely to be born preterm, diagnosed with a major birth defect, or diagnosed with a malignancy. CONCLUSIONS: In this exploratory analysis, infants born to women who inadvertently deployed to military operations during their pregnancy were not at increased risk of adverse birth or infant health outcomes. Future analyses should examine outcomes related to specific maternal exposures during deployment, and outcomes among the growing number of infants conceived after deployment.

Hypothyroidism among military infants born in countries of varied iodine nutrition status.

BACKGROUND: Iodine deficiency is a global problem representing the most common preventable cause of mental retardation. Recently, the impact of subtle deficiencies in iodine intake on children and pregnant women has been questioned. This study was designed to compare hypothyroidism among infants born to US military families in countries of varied iodine nutrition status. METHODS: A cohort design was used to analyze data from the Department of Defense Birth and Infant Health Registry for infants born in 2000-04 (n = 447,691). Hypothyroidism was defined using ICD-9-CM codes from the first year of life (n = 698). The impact of birth location on hypothyroidism was assessed by comparing rates in Germany, Japan, and US territories with the United States, while controlling for infant gender, plurality, gestational age, maternal age, maternal military status, and military parent's race/ethnicity. RESULTS: Hypothyroidism did not vary by birth location with adjusted odds ratios (OR) as follows: Germany (OR 0.82, [95% CI 0.50, 1.35]), Japan (OR 0.67, [95% CI 0.37, 1.22]), and US territories (OR 1.29, [95% CI 0.57, 2.89]). Hypothyroidism was strongly associated with preterm birth (OR 5.44, [95% CI 4.60, 6.42]). Hypothyroidism was also increased among infants with civilian mothers (OR 1.24, [95% CI 1.00, 1.54]), and older mothers, especially ages 40 years and older (OR 2.09, [95% CI 1.33, 3.30]). CONCLUSIONS: In this study, hypothyroidism in military-dependent infants did not vary by birth location, but was associated with other risk factors, including preterm birth, civilian maternal status, and advanced maternal age.

Does acute maternal stress in pregnancy affect infant health outcomes? Examination of a large cohort of infants born after the terrorist attacks of September 11, 2001.

BACKGROUND: Infants in utero during the terrorist attacks of September 11, 2001 may have been negatively affected by maternal stress. Studies to date have produced contradictory results. METHODS: Data for this retrospective cohort study were obtained from the Department of Defense Birth and Infant Health Registry and included up to 164,743 infants born to active-duty military families. Infants were considered exposed if they were in utero on September 11, 2001, while the referent group included infants gestating in the same period in the preceding and following year (2000 and 2002). We investigated the association of this acute stress during pregnancy with the infant health outcomes of male:female sex ratio, birth defects, preterm birth, and growth deficiencies in utero and in infancy. RESULTS: No difference in sex ratio was observed between infants in utero in the first trimester of pregnancy on September 11, 2001 and infants in the referent population. Examination of the relationship between first-trimester exposure and birth defects also revealed no significant associations. In adjusted multivariable models, neither preterm birth nor growth deficiencies were significantly associated with the maternal exposure to the stress of September 11 during pregnancy. CONCLUSION: The findings from this large population-based study suggest that women who were pregnant during the terrorist attacks of September 11, 2001 had no increased risk of adverse infant health outcomes.

Haemangiomas and associated congenital malformations in a large population-based sample of infants.

Haemangiomas are common, benign, vascular tumours, observed in 4-12% of infants during the first year of life. Most cases progress without complication, yet a small proportion experience life-threatening complications. Concomitant congenital malformations have been reported in a small but significant proportion of haemangioma patients. This study aimed to describe haemangioma cases and to identify patterns of congenital malformations associated with these diagnoses in a large population. Diagnoses of haemangiomas and 21 congenital malformations were extracted from electronic medical records of 467 295 singleton infants born to US military families from 1998 to 2003. Cluster analysis was used to group cases according to these diagnoses. Multivariable logistic regression was used to further explore the associations of the 21 congenital malformations with the diagnosis of haemangioma and to assess the adjusted relationships between a number of characteristics of interest and diagnosis of haemangioma. Clusters found to be associated with haemangioma were characterised by anomalies of the cervix, vagina, and external female genitalia, anophthalmia or microphthalmia, hydrocephalus without spina bifida, and reduction deformities of the brain. Logistic regression identified three congenital malformations significantly associated with haemangioma diagnosis: spina bifida without anencephalus, hydrocephalus without spina bifida, and anomalies of the cervix, vagina and external female genitalia. Characteristics significantly associated with haemangioma included female gender, preterm birth, white non-Hispanic race/ethnicity and increasing maternal age. This exploratory study identified a number of important associations between haemangiomas and congenital malformations that may provide insight into the pathogenesis of these disorders and have possible implications for clinical care.

Birth defects among infants born to women who received anthrax vaccine in pregnancy.

In response to bioterrorism threats, anthrax vaccine has been used by the US military and considered for civilian use. Concerns exist about the potential for adverse reproductive health effects among vaccine recipients. This retrospective cohort evaluated birth defects, in relation to maternal anthrax vaccination, among all infants born to US military service women between 1998 and 2004. Department of Defense databases defined maternal vaccination and infant diagnoses; multivariable regression models described potential associations between anthrax vaccination and birth defects in liveborn infants. Among 115,169 infants born to military women during this period, 37,140 were born to women ever vaccinated against anthrax, and 3,465 were born to women vaccinated in the first trimester of pregnancy. Birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18, 95% confidence interval: 0.997, 1.41) when compared with infants of women vaccinated outside of the first trimester, but this association was statistically significant only when alternative referent groups were used. Although the small observed association may be unlikely to represent a causal relation between vaccination in early pregnancy and birth defects, this information should be considered when making decisions about administering anthrax vaccine to pregnant women.