Association between Diabetes in Pregnancy and Shoulder Dystocia by Infant Birth Weight in an Era of Cesarean Delivery for Suspected Macrosomia.

OBJECTIVE: We estimated the association between diabetes and shoulder dystocia by infant birth weight subgroups (<4,000, 4,000-4,500, and >4,500 g) in an era of prophylactic cesarean delivery for suspected macrosomia. STUDY DESIGN: A secondary analysis from the National Institute of Child Health and Human Development U.S. Consortium for Safe Labor of deliveries at ≥24 weeks with a nonanomalous, singleton fetus with vertex presentation undergoing a trial of labor. The exposure was either pregestational or gestational diabetes compared with no diabetes. The primary outcome was shoulder dystocia and secondarily, birth trauma with a shoulder dystocia. We calculated adjusted risk ratios (aRRs) with modified Poison's regression between diabetes and shoulder dystocia and the number needed to treat (NNT) to prevent a shoulder dystocia with cesarean delivery. RESULTS: Among 167,589 assessed deliveries (6% with diabetes), pregnant individuals with diabetes had a higher risk of shoulder dystocia at birth weight <4,000 g (aRR: 1.95; 95% confidence interval [CI]: 1.66-2.31) and 4,000 to 4,500 g (aRR: 1.57; 95% CI: 1.24-1.99), albeit not significantly at birth weight >4,500 g (aRR: 1.26; 95% CI: 0.87-1.82) versus those without diabetes. The risk of birth trauma with shoulder dystocia was higher with diabetes (aRR: 2.29; 95% CI: 1.54-3.45). The NNT to prevent a shoulder dystocia with diabetes was 11 and 6 at ≥4,000 and >4,500 g, versus without diabetes, 17 and 8 at ≥4,000 and >4,500 g, respectively. CONCLUSION: Diabetes increased the risk of shoulder dystocia, even at lower birth weight thresholds than at which cesarean delivery is currently offered. Guidelines providing the option of cesarean delivery for suspected macrosomia may have decreased the risk of shoulder dystocia at higher birth weights. KEY POINTS: · >Diabetes increased the risk of shoulder dystocia, even at lower birth weight thresholds than at which cesarean delivery is currently offered.. · Cesarean delivery for suspected macrosomia may have decreased the risk of shoulder dystocia at higher birth weights.. · These findings can inform delivery planning for providers and pregnant individuals with diabetes..

Association of change in haemoglobin A1c with adverse perinatal outcomes in women with pregestational diabetes.

AIMS: To determine whether a net decline in glycosylated haemoglobin (HbA1c ) from early to late pregnancy is associated with lower risk of adverse perinatal outcomes at delivery among women with pregestational diabetes. METHODS: A retrospective analysis from 2012 to 2016 at a tertiary care centre. The exposure was the net change in HbA1c from early (<20 weeks gestation) to late pregnancy (≥20 weeks gestation). Primary outcomes were large for gestational age (LGA) and neonatal hypoglycaemia. The association between outcomes per 6 mmol/mol (0.5%) absolute decrease in HbA1c was evaluated using modified Poisson regression, and adjusted for age, body mass index, White Class, early HbA1c and haemoglobin and gestational age at HbA1c measurement and delivery. RESULTS: Among 347 women with pregestational diabetes, HbA1c was assessed in early (9 weeks [IQR 7,13]) and late pregnancy (31 weeks [IQR 29,34]). Mean HbA1c decreased from early (59 mmol/mol [7.5%]) to late (47 mmol/mol [6.5%]) pregnancy. Each 6 mmol/mol (0.5%) absolute decrease in HbA1c was associated with a 12% reduced risk of LGA infant (30%, aRR:0.88; 95% CI:0.81,0.95), and a 7% reduced risk of neonatal hypoglycaemia (35%, aRR:0.93; 95% CI:0.87,0.99). Preterm birth (36%, aRR:0.93; 95% CI:0.89,0.98) and neonatal intensive care unit admission (55%, aRR:0.95; 95% CI:0.91,0.98) decreased with a net decline in HbA1c , but not caesarean delivery, pre-eclampsia, shoulder dystocia and respiratory distress syndrome. CONCLUSIONS: Women with pregestational diabetes with a reduction in HbA1c may have fewer infants born LGA or with neonatal hypoglycaemia. Repeated assessment of HbA1c may provide an additional measure of glycaemic control.

Differences in Hemoglobin A1c during Pregnancy between Non-Hispanic Black versus White Women with Prepregnancy Diabetes.

OBJECTIVE: The objective of this was to determine whether the change in hemoglobin A1c (HbA1c) from early to late pregnancy differs between non-Hispanic Black and White women with prepregnancy diabetes. STUDY DESIGN: A retrospective analysis was performed from an integrated prenatal and diabetes care program from 2012 to 2016. We compared HbA1c as a continuous measure and secondarily, HbA1c <6.5%, cross-sectionally, and longitudinally in early (approximately 10 weeks) and late (approximately 31 weeks) pregnancies. Linear and logistic regression were used and adjusted for age, body mass index, White diabetes class, medication use, diabetes type, gestational age at baseline HbA1c measurement, and baseline hemoglobin. RESULTS: Among 296 non-Hispanic Black (35%) and White pregnant women (65%) with prepregnancy diabetes (39% type 1 and 61% type 2), Black women were more likely to experience increased community-level social determinants of health as measured by the Social Vulnerability Index (SVI) and were less likely to have type 1 diabetes and have more severe diabetes versus White women (p < 0.05). Black women had higher mean HbA1c (7.8 vs. 7.4%; beta: 0.75; 95% confidence interval [CI]: 0.30-1.19) and were less likely to have HbA1c < 6.5% at 10 weeks compared with White women (24 vs. 35%; adjusted odds ratio: 0.45; 95% CI: 0.24-0.81) but not after adjusting for SVI. At 31 weeks, both groups had similar mean HbA1c (both 6.5%) and were equally as likely to have HbA1c < 6.5% (57 vs. 54%). From early to late pregnancy, Black women had a higher percentage decrease in HbA1c (1.3 vs. 0.9%; beta = 0.63; 95% CI: 0.27-0.99) and were equally as likely to have an improvement or stable HbA1C < 6.5% from 10 to 31 weeks, with both groups having a similar mean HbA1c (6.5%) at 31 weeks. CONCLUSION: Despite experiencing greater community-level social determinants of health, Black women with pregestational diabetes had a larger reduction in HbA1c and were able to equally achieve the target of HbA1c < 6.5% by late pregnancy compared with White women as part of an integrated diabetes and prenatal care program. KEY POINTS: · An integrated diabetes and pregnancy care program may decrease racial and ethnic disparities in glycemic control.. · Black women had a larger reduction in HbA1c versus White women.. · Black women were able to equally achieve the target of HbA1c < 6.5% by late pregnancy versus White women..

Risk of Adverse Pregnancy Outcomes Among Pregnant Individuals With Gestational Diabetes by Race and Ethnicity in the United States, 2014-2020.

Importance: Gestational diabetes, which increases the risk of adverse pregnancy outcomes, has been increasing in frequency across all racial and ethnic subgroups in the US. Objective: To assess whether the frequency of adverse pregnancy outcomes among those in the US with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity. Design, Setting, and Participants: Exploratory serial, cross-sectional, descriptive study using US National Center for Health Statistics natality data for 1 560 822 individuals with gestational diabetes aged 15 to 44 years with singleton nonanomalous live births from 2014 to 2020 in the US. Exposures: Year of delivery and race and ethnicity, as reported on the birth certificate, stratified as non-Hispanic American Indian, non-Hispanic Asian/Pacific Islander, non-Hispanic Black, Hispanic/Latina, and non-Hispanic White (reference group). Main Outcomes and Measures: Maternal outcomes of interest included cesarean delivery, primary cesarean delivery, preeclampsia or gestational hypertension, intensive care unit (ICU) admission, and transfusion; neonatal outcomes included large for gestational age (LGA), macrosomia (>4000 g at birth), small for gestational age (SGA), preterm birth, and neonatal ICU (NICU) admission, as measured by the frequency (per 1000 live births) with estimation of mean annual percentage change (APC), disparity ratios, and adjusted risk ratios. Results: Of 1 560 822 included pregnant individuals with gestational diabetes (mean [SD] age, 31 [5.5] years), 1% were American Indian, 13% were Asian/Pacific Islander, 12% were Black, 27% were Hispanic/Latina, and 48% were White. From 2014 to 2020, there was a statistically significant increase in the overall frequency (mean APC per year) of preeclampsia or gestational hypertension (4.2% [95% CI, 3.3% to 5.2%]), transfusion (8.0% [95% CI, 3.8% to 12.4%]), preterm birth at less than 37 weeks (0.9% [95% CI, 0.3% to 1.5%]), and NICU admission (1.0% [95% CI, 0.3% to 1.7%]). There was a significant decrease in cesarean delivery (-1.4% [95% CI, -1.7% to -1.1%]), primary cesarean delivery (-1.2% [95% CI, -1.5% to -0.9%]), LGA (-2.3% [95% CI, -2.8% to -1.8%]), and macrosomia (-4.7% [95% CI, -5.3% to -4.0%]). There was no significant change in maternal ICU admission and SGA. In comparison with White individuals, Black individuals were at significantly increased risk of all assessed outcomes, except LGA and macrosomia; American Indian individuals were at significantly increased risk of all assessed outcomes except cesarean delivery and SGA; and Hispanic/Latina and Asian/Pacific Islander individuals were at significantly increased risk of maternal ICU admission, preterm birth, NICU admission, and SGA. Differences in adverse outcomes by race and ethnicity persisted through these years. Conclusions and Relevance: From 2014 through 2020, the frequency of multiple adverse pregnancy outcomes in the US increased among pregnant individuals with gestational diabetes. Differences in adverse outcomes by race and ethnicity persisted.

Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial.

BACKGROUND: Up to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postpartum weight loss and contribute to T2DM prevention efforts. However, some women have difficulty prioritizing self-care during this life stage. Efficacious interventions that women can balance with motherhood to reduce T2DM risk remain a goal. The objective of the Moms in Motion study is to evaluate the efficacy of a simple, novel, activity-boosting intervention using ankle weights worn with daily activities during a 6-month postpartum intervention among women with GDM. We hypothesize that women randomized to the 6-month intensity-modifying intervention will (1) demonstrate greater weight loss and (2) greater improvement in body composition and biomarker profile versus controls. METHODS: This study will be a parallel two-arm randomized controlled trial (n = 160). Women will be allocated 1:1 to an ankle weight intervention group or a standard-of-care control group. The intervention uses ankle weights (1.1 kg) worn on each ankle during routine daily activities (e.g., cleaning, childcare). Primary outcomes include pre- and post-assessments of weight from Visit 2 to Visit 3. Secondary outcomes include body composition, glycemia (2-h, 75 g oral glucose tolerance test), and fasting insulin. Exploratory outcomes include energy expenditure, diet, and psychosocial well-being. DISCUSSION: Beyond the expected significance of this study in its direct health impacts from weight loss, it will contribute to exploring (1) the mechanism(s) by which the intervention is successful (mediating effects of energy expenditure and diet on weight loss) and (2) the effects of the intervention on body composition and biomarkers associated with insulin resistance and metabolic health. Additionally, we expect the findings to be meaningful regarding the intervention's effectiveness on engaging women with GDM in the postpartum period to reduce T2DM risk. TRIAL REGISTRATION: The ClinicalTrials.gov Identifier, is NCT03664089 . The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim.

Reverse Sequence Syphilis Screening and Discordant Results in Pregnancy.

A "reverse sequence syphilis screening" algorithm is widely used for syphilis testing. This retrospective study showed that most (65%) pregnant women with discordant screening results (treponemal multiplex flow immunoassay IgG+/rapid plasma reagin-) had a nonreactive confirmatory Treponema pallidum-particle agglutination assay, likely indicative of a false-positive reaction.

The Accuracy and Cost-Effectiveness of Selective Fetal Echocardiography for the Diagnosis of Congenital Heart Disease in Patients with Pregestational Diabetes Stratified by Hemoglobin A1c.

OBJECTIVE: To evaluate the accuracy of antenatal diagnosis of congenital heart disease (CHD) using screening methods including a combination of elevated hemoglobin A1c, detailed anatomy ultrasound, and fetal echocardiography. STUDY DESIGN: This is a retrospective cohort study of all pregnancies complicated by pregestational diabetes from January 2012 to December 2016. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for each screening regimen. The incremental cost-effectiveness ratio (ICER) was calculated for each regimen with effectiveness defined as additional CHD diagnosed. RESULTS: A total of 378 patients met inclusion criteria with an overall prevalence of CHD of 4.0% (n = 15). When compared with a detailed ultrasound, fetal echocardiography had a higher sensitivity (73.3 vs. 40.0%). However, all cases of major CHD were detected by detailed ultrasound (n = 6). Using an elevated early A1c > 7.7% and a detailed ultrasound resulted in a sensitivity and specificity of 60.0 and 99.4%, respectively. The use of selective fetal echocardiography for an A1c > 7.7% or abnormal detailed anatomy ultrasound would result in a 63.3% reduction in cost per each additional minor CHD diagnosed (ICER: $18,290.52 vs. $28,875.67). CONCLUSION: Fetal echocardiography appears to have limited diagnostic value in women with pregestational diabetes. However, these results may not be generalizable outside of a high-volume academic setting.

Likelihood of cesarean delivery after applying leading active labor diagnostic guidelines.

BACKGROUND: Friedman, the United Kingdom's National Institute for Health and Care Excellence (NICE), and the American College of Obstetricians and Gynecologists/Society for Maternal-Fetal Medicine (ACOG/SMFM) support different active labor diagnostic guidelines. Our aims were to compare likelihoods for cesarean delivery among women admitted before vs in active labor by diagnostic guideline (within-guideline comparisons) and between women admitted in active labor per one or more of the guidelines (between-guideline comparisons). DESIGN: Active labor diagnostic guidelines were retrospectively applied to cervical examination data from nulliparous women with spontaneous labor onset (n = 2573). Generalized linear models were used to determine outcome likelihoods within- and between-guideline groups. RESULTS: At admission, 15.7%, 48.3%, and 10.1% of nulliparous women were in active labor per Friedman, NICE, and ACOG/SMFM diagnostic guidelines, respectively. Cesarean delivery was more likely among women admitted before vs in active labor per the Friedman (AOR 1.75 [95% CI 1.08-2.82] or NICE guideline (AOR 2.55 [95% CI 1.84-3.53]). Between guidelines, cesarean delivery was less likely among women admitted in active labor per the NICE guideline, as compared with the ACOG/SMFM guideline (AOR 0.55 [95% CI 0.35-0.88]). CONCLUSION: Many nulliparous women are admitted to the hospital before active labor onset. These women are significantly more likely to have a cesarean delivery. Diagnosing active labor before admission or before intervention to speed labor may be one component of a multi-faceted approach to decreasing the primary cesarean rate in the United States. The NICE diagnostic guideline is more inclusive than Friedman or ACOG/SMFM guidelines and its use may be the most clinically useful for safely lowering cesarean rates.

Compartmentalization of acute phase reactants Interleukin-6, C-Reactive Protein and Procalcitonin as biomarkers of intra-amniotic infection and chorioamnionitis.

BACKGROUND: The arsenal of maternal and amniotic fluid (AF) immune response to local or systemic infection includes among others the acute-phase reactants IL-6, C-Reactive Protein (CRP) and Procalcitonin (PCT). If these molecules can be used as non-invasive biomarkers of intra-amniotic infection (IAI) in the subclinical phase of the disease remains incompletely known. METHODS: We used time-matched maternal serum, urine and AF from 100 pregnant women who had an amniocentesis to rule out IAI in the setting of preterm labor, PPROM or systemic inflammatory response (SIR: pyelonephritis, appendicitis, pneumonia) to infection. Cord blood was analyzed in a subgroup of cases. We used sensitive immunoassays to quantify the levels of inflammatory markers in the maternal blood, urine and AF compartment. Microbiological testing and placental pathology was used to establish infection and histological chorioamnionitis. RESULTS: PCT was not a useful biomarker of IAI in any of the studied compartments. Maternal blood IL-6 and CRP levels were elevated in women with subclinical IAI. Compared to clinically manifest chorioamnionitis group, women with SIR have higher maternal blood IL-6 levels rendering some marginal diagnostic benefit for this condition. Urine was not a useful biological sample for assessment of IAI using either of these three inflammatory biomarkers. CONCLUSIONS: In women with subclinical IAI, the large overlapping confidence intervals and different cut-offs for the maternal blood levels of IL-6, CRP and PCT likely make interpretation of their absolute values difficult for clinical decision-making.

Cost-effectiveness of transvaginal ultrasound cervical length screening in singletons without a prior preterm birth: an update.

OBJECTIVE: We sought to reevaluate the cost-effectiveness of universal transvaginal ultrasound (TVU) cervical length (CL) screening in singleton pregnancies without prior spontaneous preterm birth. STUDY DESIGN: We developed a decision model to assess costs and effects of universal TVU CL screening at 18-23 weeks' gestation compared to routine care for singleton pregnancies without prior preterm birth. Based on recent data, the model contains the following updates: (1) reduced incidence of CL ≤20 mm at initial screening ultrasound (0.83%), (2) vaginal progesterone supplementation for women with CL ≤20 mm, (3) additional ultrasound(s) for women with CL 21-24.9 mm, and (4) the assumption that vaginal progesterone reduces the rate of preterm birth <34 weeks' gestation by 39% if a short CL is diagnosed. The primary outcome was incremental cost-effectiveness ratio. We assumed a willingness to pay of $100,000 per quality-adjusted life year (QALY) gained. Additional outcomes included incidence of offspring with long-term neurological deficits and neonatal death. Sensitivity analyses were performed to assess the robustness of the results. RESULTS: For every 100,000 women screened, universal TVU CL screening costs $9132 compared to routine care. Screening results in 215 QALYs gained and 10 fewer neonatal deaths or neonates with long-term neurologic deficits per 100,000 women screened. Based on the updated data, universal CL screening in low-risk women remains a cost-effective strategy (incremental cost-effectiveness ratio = $43/QALY), but is not cost saving as previously estimated. Sensitivity analyses reveal that when incidence of TVU CL ≤20 mm is <0.31%, universal TVU CL screening is no longer cost-effective. Additionally, when TVU CL costs >$314, progesterone reduces preterm delivery risk before 34 weeks <19%, or the incidence of a TVU CL 21-24.9 mm is >6.5%, CL screening is also no longer cost-effective. CONCLUSION: Despite the reduced incidence and efficacy used in this model, universal TVU CL continues to be cost-effective when compared to routine care in singletons without prior preterm birth.

A comprehensive obstetric patient safety program reduces liability claims and payments.

Begun in 2003, the Yale-New Haven Hospital comprehensive obstetric safety program consisted of measures to standardize care, improve teamwork and communication, and optimize oversight and quality review. Prior publications have demonstrated improvements in adverse outcomes and safety culture associated with this program. In this analysis, we aimed to assess the impact of this program on liability claims and payments at a single institution. We reviewed liability claims at a single, tertiary-care, teaching hospital for two 5-year periods (1998-2002 and 2003-2007), before and after implementing the safety program. Connecticut statute of limitations for professional malpractice is 36 months from injury. Claims/events were classified by event-year and payments were adjusted for inflation. We analyzed data for trends as well as differences between periods before and after implementation. Forty-four claims were filed during the 10-year study period. Annual cases per 1000 deliveries decreased significantly over the study period (P < .01). Claims (30 vs 14) and payments ($50.7 million vs $2.9 million) decreased in the 5-years after program inception. Compared with before program inception, median annual claims dropped from 1.31 to 0.64 (P = .02), and median annual payments per 1000 deliveries decreased from $1,141,638 to $63,470 (P < .01). Even estimating the monetary awards for the 2 remaining open cases using the median payments for the surrounding 5 years, a reduction in the median monetary amount per case resulting in payment to the claimant was also statistically significant ($632,262 vs $216,815, P = .046). In contrast, the Connecticut insurance market experienced a stable number of claims and markedly increased cost per claim during the same period. We conclude that an obstetric safety initiative can improve liability claims exposure and reduce liability payments.

IL-6 trans-signaling system in intra-amniotic inflammation, preterm birth, and preterm premature rupture of the membranes.

Classic IL-6 signaling is conditioned by the transmembrane receptor (IL-6R) and homodimerization of gp130. During trans-signaling, IL-6 binds to soluble IL-6R (sIL-6R), enabling activation of cells expressing solely gp130. Soluble gp130 (sgp130) selectively inhibits IL-6 trans-signaling. To characterize amniotic fluid (AF) IL-6 trans-signaling molecules (IL-6, sIL-6R, sgp130) in normal gestations and pregnancies complicated by intra-amniotic inflammation (IAI), we studied 301 women during second trimester (n = 39), third trimester (n = 40), and preterm labor with intact (n = 131, 85 negative IAI and 46 positive IAI) or preterm premature rupture of membranes (PPROM; n = 91, 61 negative IAI and 30 positive IAI). ELISA, Western blotting, and real-time RT-PCR were used to investigate AF, placenta, and amniochorion for protein and mRNA expression of sIL-6R, sgp130, IL-6R, and gp130. Tissues were immunostained for IL-6R, gp130, CD15(+) (polymorphonuclear), and CD3(+) (T cell) inflammatory cells. The ability of sIL-6R and sgp130 to modulate basal and LPS-stimulated release of amniochorion matrix metalloprotease-9 was tested ex vivo. We showed that in physiologic gestations, AF sgp130 decreases toward term. AF IL-6 and sIL-6R were increased in IAI, whereas sgp130 was decreased in PPROM. Our results suggested that fetal membranes are the probable source of AF sIL-6R and sgp130. Immunohistochemistry and RT-PCR revealed increased IL-6R and decreased gp130 expression in amniochorion of women with IAI. Ex vivo, sIL-6R and LPS augmented amniochorion matrix metalloprotease-9 release, whereas sgp130 opposed this effect. We conclude that IL-6 trans-signaling molecules are physiologic constituents of the AF regulated by gestational age and inflammation. PPROM likely involves functional loss of sgp130.

Fetal surveillance and timing of delivery in pregnancy complicated by diabetes mellitus.

Diabetes concurrent with pregnancy is a high-risk condition associated with risks for adverse pregnancy outcomes. Historically, these risks were unacceptably high and a policy of late preterm delivery induction was the rule. With the advent of improved glycemic management and the introduction of antenatal fetal testing and surveillance, the perinatal risks have dropped significantly such that a healthy pregnancy is expected. Managing stable women with diabetes mellitus to 39 and 40 weeks is now commonplace as fetal surveillance tools such as nonstress testing and biophysical profiles have sufficiently low false-negative rates that providers can feel assured that expectantly managing these pregnancies close to term can be done with minimal risk. However, providers cannot become complacent, and the results of fetal surveillance, clinical characteristics of the pregnancy, and expected neonatal outcomes all need to be accounted when deciding the optimal gestational age to deliver a child.

Association of community walkability and glycemic control among pregnant individuals with pregestational diabetes mellitus.

BACKGROUND: Neighborhood walkability is a community-level social determinant of health that measures whether people who live in a neighborhood walk as a mode of transportation. Whether neighborhood walkability is associated with glycemic control among pregnant individuals with pregestational diabetes remains to be defined. OBJECTIVE: This study aimed to evaluate the association between community-level neighborhood walkability and glycemic control as measured by hemoglobin A1c (A1C) among pregnant individuals with pregestational diabetes. STUDY DESIGN: This was a retrospective analysis of pregnant individuals with pregestational diabetes enrolled in an integrated prenatal and diabetes care program from 2012 to 2016. Participant addresses were geocoded and linked at the census-tract level. The exposure was community walkability, defined by the US Environmental Protection Agency National Walkability Index (score range 1-20), which incorporates intersection density (design), proximity to transit stops (distance), and a mix of employment and household types (diversity). Individuals from neighborhoods that were the most walkable (score, 15.26-20.0) were compared with those from neighborhoods that were less walkable (score <15.26), as defined per national Environmental Protection Agency recommendations. The outcomes were glycemic control, including A1C <6.0% and <6.5%, measured both in early and late pregnancy, and mean change in A1C across pregnancy. Modified Poisson regression and linear regression were used, respectively, and adjusted for maternal age, body mass index at delivery, parity, race and ethnicity as a social determinant of health, insurance status, baseline A1C, gestational age at A1C measurement in early and late pregnancy, and diabetes type. RESULTS: Among 417 pregnant individuals (33% type 1, 67% type 2 diabetes mellitus), 10% were living in the most walkable communities. All 417 individuals underwent A1C assessment in early pregnancy (median gestational age, 9.7 weeks; interquartile range, 7.4-14.1), and 376 underwent another A1C assessment in late pregnancy (median gestational age, 30.4 weeks; interquartile range, 27.8-33.6). Pregnant individuals living in the most walkable communities were more likely to have an A1C <6.0% in early pregnancy (15% vs 8%; adjusted relative risk, 1.46; 95% confidence interval, 1.00-2.16), and an A1C <6.5% in late pregnancy compared with those living in less walkable communities (13% vs 9%; adjusted relative risk, 1.33; 95% confidence interval, 1.08-1.63). For individuals living in the most walkable communities, the median A1C was 7.5 (interquartile range, 6.0-9.4) in early pregnancy and 5.9 (interquartile range, 5.4-6.4) in late pregnancy. For those living in less walkable communities, the median A1C was 7.3 (interquartile range, 6.2-9.2) in early pregnancy and 6.2 (interquartile range, 5.6-7.1) in late pregnancy. Change in A1C across pregnancy was not associated with walkability. CONCLUSION: Pregnant individuals with pregestational diabetes mellitus living in more walkable communities had better glycemic control in both early and late pregnancy. Whether community-level interventions to enhance neighborhood walkability can improve glycemic control in pregnancy requires further study.

Association of community-level food insecurity and glycemic control among pregnant individuals with pregestational diabetes.

AIM: To evaluate whether pregnant individuals with pregestational diabetes who live in a food-insecure community have worse glycemic control compared to those who do not live in a food-insecure community. METHODS: A retrospective analysis of pregnant individuals with pregestational diabetes enrolled in a multidisciplinary prenatal and diabetes care program. The exposure was community-level food insecurity per the Food Access Research Atlas. The outcomes were hemoglobin A1c (A1c) < 6.0 % in early and late pregnancy, and an absolute decrease in A1c ≥ 2.0 % and mean change in A1c across pregnancy. RESULTS: Among 418 assessed pregnant individuals with pregestational diabetes, those living in a food-insecure community were less likely to have an A1c < 6.0 % in early pregnancy compared to those living in a community without food insecurity [16 % vs. 30 %; adjusted risk ratio (aRR): 0.55; 95 % CI: 0.33-0.92]. Individuals living in a food-insecure community were more likely to achieve a decrease in A1c ≥ 2.0 % [35 % vs. 21 %; aRR: 1.55; 95 % CI: 1.06-2.28] and a larger mean decrease in A1c across pregnancy [mean: 1.46 vs. 1.00; adjusted beta: 0.47; 95 % CI: 0.06-0.87)]. CONCLUSIONS: Pregnant individuals with pregestational diabetes who lived in a food-insecure community were less likely to enter pregnancy with glycemic control, but were more likely to have a reduction in A1c and achieve similar A1c status compared to those who lived in a community without food insecurity. Whether interventions that address food insecurity improve glycemic control and consequent perinatal outcomes remains to be studied.

Cost-effectiveness of percutaneous tibial nerve stimulation versus extended release tolterodine for overactive bladder.

PURPOSE: We assessed the cost-effectiveness of percutaneous tibial nerve stimulation vs extended release tolterodine for the treatment of overactive bladder. MATERIALS AND METHODS: A 1-year time frame cost-effectiveness model from a societal perspective was developed by comparing medical costs and quality of life determined by improved continence and therapy side effects of percutaneous tibial nerve stimulation and tolterodine ER. Percutaneous tibial nerve stimulation therapy consisted of 12 sessions for 3 months followed by maintenance therapy. Significant side effects of both strategies can result in reduced quality of life or therapy termination. Parameter estimates included utilities of improved urinary incontinence (0.92) and continued urinary incontinence (0.73), reduction in quality of life from side effects (5%), cost of percutaneous tibial nerve stimulation per session ($203) and cost of tolterodine ER per month ($150). Our primary outcome was the incremental cost-effectiveness ratio, defined as the marginal cost per quality adjusted life-years gained. Less than $50,000 per quality adjusted life-year gained was considered cost-effective. The uncertainty of input parameters was addressed by 1-way sensitivity analyses and Monte Carlo simulation to assess the robustness of the model. RESULTS: Percutaneous tibial nerve stimulation added significant cost to the management of overactive bladder with modest improvement in quality of life. For every 100 patients treated with percutaneous tibial nerve stimulation the costs increased by $303,480 and resulted in an additional 4.3 quality adjusted life-years gained compared to tolterodine ER. The incremental cost-effectiveness ratio was $70,754 per quality adjusted life-year gained. In the Monte Carlo analysis percutaneous tibial nerve stimulation was cost-effective only 21% of the time. CONCLUSIONS: Percutaneous tibial nerve stimulation was not cost-effective for treating overactive bladder vs tolterodine ER under a wide range of clinical circumstances.

Antenatal lamivudine to reduce perinatal hepatitis B transmission: a cost-effectiveness analysis.

OBJECTIVES: This study aimed to determine whether administration of lamivudine to pregnant women with chronic hepatitis B in the third trimester is a cost-effective strategy in preventing perinatal transmission. STUDY DESIGN: We developed a decision analysis model to compare the cost-effectiveness of 2 management strategies for chronic hepatitis B in pregnancy: (1) expectant management or (2) lamivudine administration in the third trimester. We assumed that lamivudine reduced perinatal transmission by 62%. RESULTS: Our Markov model demonstrated that lamivudine administration is the dominant strategy. For every 1000 infected pregnant women treated with lamivudine, $337,000 is saved and 314 quality-adjusted life-years are gained. For every 1000 pregnancies with maternal hepatitis B, lamivudine prevents 21 cases of hepatocellular carcinoma and 5 liver transplants in the offspring. The model remained robust in sensitivity analysis. CONCLUSION: Antenatal lamivudine administration to pregnant patients with hepatitis B is cost-effective, and frequently cost-saving, under a wide range of circumstances.

Screening, brief intervention, and referral to treatment (SBIRT) for alcohol and other drug use among adolescents: evaluation of a pediatric residency curriculum.

The objective of this study was to evaluate the integration of a screening, brief intervention, and referral to treatment (SBIRT) curriculum for alcohol and other drug use into a pediatric residency program. Pediatric and medicine/pediatric residents in an adolescent medicine rotation located in an urban teaching hospital participated in the study. Main outcome measures were pre- and post-training knowledge scores, performance of the Brief Negotiation Interview (BNI), training satisfaction, and adoption of the BNI into clinical practice. Thirty-four residents were trained. Significant pre- to post-training improvements were seen in knowledge scores (P < .001) and performance as measured by the BNI Adherence Scale (P < .001). Residents reported high satisfaction immediately post-training and at 30 days on a 1-5 Likert scale: mean 1.41 to 1.59 (1 = very satisfied) (P = 0.23). Over a 9-month period, 53% of residents documented performing at least 1 BNI, of which 2/3 reported ≥2 BNIs in a subsequent clinical setting. The results show that integrating a SBIRT curriculum into a pediatric residency program increases residents' knowledge and skills.

Developing and implementing a multispecialty graduate medical education curriculum on Screening, Brief Intervention, and Referral to Treatment (SBIRT).

The authors sought to evaluate the feasibility and acceptability of initiating a Screening, Brief Intervention, and Referral to Treatment (SBIRT) for alcohol and other drug use curriculum across multiple residency programs. SBIRT project faculty in the internal medicine (traditional, primary care internal medicine, medicine/pediatrics), psychiatry, obstetrics and gynecology, emergency medicine, and pediatrics programs were trained in performing and teaching SBIRT. The SBIRT project faculty trained the residents in their respective disciplines, accommodating discipline-specific implementation issues and developed a SBIRT training Web site. Post-training, residents were observed performing SBIRT with a standardized patient. Measurements included number of residents trained, performance of SBIRT in clinical practice, and training satisfaction. One hundred and ninety-nine residents were trained in SBIRT: 98 internal medicine, 35 psychiatry, 18 obstetrics and gynecology, 21 emergency medicine, and 27 pediatrics residents. To date, 338 self-reported SBIRT clinical encounters have occurred. Of the 196 satisfaction surveys completed, the mean satisfaction score for the training was 1.60 (1 = very satisfied to 5 = very dissatisfied). Standardized patient sessions with SBIRT project faculty supervision were the most positive aspect of the training and length of training was a noted weakness. Implementation of a graduate medical education SBIRT curriculum in a multispecialty format is feasible and acceptable. Future efforts focusing on evaluation of resident SBIRT performance and sustainability of SBIRT are needed.

A comprehensive obstetrics patient safety program improves safety climate and culture.

OBJECTIVE: The purpose of this study was to determine the effect of an obstetrics patient safety program on staff safety culture. STUDY DESIGN: We implemented (1) obstetrics patient safety nurse, (2) protocol-based standardization of practice, (3) crew resource management training, (4) oversight by a patient safety committee, (5) 24-hour obstetrics hospitalist, and (6) an anonymous event reporting system. We administered the Safety Attitude Questionnaire on 4 occasions over 5 years (2004-2009) to all staff members that assessed teamwork and safety cultures, job satisfaction, working conditions, stress recognition, and perceptions of management. RESULTS: We observed significant improvements in the proportion of staff members with favorable perceptions of teamwork culture (39% in 2004 to 63% in 2009), safety culture (33% to 63%), job satisfaction (39% to 53%), and management (10% to 37%). Individual roles (obstetrics providers, residents, and nurses) also experienced improvements in safety and teamwork, with significantly better congruence between doctors and nurses. CONCLUSION: Safety programs can improve workforce perceptions of safety and an improved safety climate.