Trends in Delayed Diagnosis of Critical Congenital Heart Defects in an Era of Enhanced Screening, 2004-2018.

OBJECTIVE: To describe trends in delayed diagnosis of critical congenital heart defects (CCHDs) with prenatal and postnatal screening advances. STUDY DESIGN: We evaluated a retrospective cohort of live births with CCHD delivered between 2004 and 2018 from a statewide, population-based birth defects surveillance system in Massachusetts. Demographic information were obtained from vital records. We estimated timely (prenatal or birth/transfer hospital) and delayed diagnosis (after discharge) proportions by year and time periods coinciding with the transition to mandatory pulse oximetry in 2015. RESULTS: We identified 1524 eligible CCHD cases among 1 087 027 live births. By 2018, 92% of cases received a timely diagnosis, most prenatally. From 2004 to 2018, prenatal diagnosis increased from 46% to 76% of cases, while hospital diagnosis decreased from 38% to 17%, and delayed diagnosis declined from 16% to 7%. These trends were consistent across all characteristics evaluated. Among cases without a prenatal diagnosis, the proportion with delayed diagnosis did not change over time, even after implementation of mandatory pulse oximetry screening. Prenatal detection increased the most among severe cases (treated or died in first month of life). Well-appearing newborns without prenatal diagnosis made up 79% of delayed diagnosis cases by 2015-2018. Delayed diagnosis was most common for coarctation. CONCLUSIONS: While prenatal diagnosis of CCHD increased dramatically, there was no reduction in delayed diagnosis among postnatally diagnosed infants, even after pulse oximetry screening became mandatory. Pulse oximetry may not reduce delayed diagnosis in settings with high prenatal detection, and other strategies are needed to ensure timely diagnosis of well-appearing newborns.

Clinical and economic evaluation of a proteomic biomarker preterm birth risk predictor: cost-effectiveness modeling of prenatal interventions applied to predicted higher-risk pregnancies within a large and diverse cohort.

OBJECTIVES: Preterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment. METHODS: The ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p < .05). RESULTS: The model predicted improvements for all outcomes. RP-CM decreased neonatal and maternal hospital stay by 19% (p = .029) and 8.5% (p = .001), respectively; neonatal costs' point estimate by 16% (p = .098); and moderate-to-severe neonatal morbidity/mortality by 29% (p = .025). RP-MM strengthened observed reductions and significance. Point estimates of benefit did not differ by race/ethnicity. CONCLUSIONS: Modeled evaluation of a biomarker-based test-and-treat strategy in a diverse population predicts clinically and economically meaningful improvements in neonatal and maternal outcomes.

Preterm birth, defined as delivery before 37 weeks' gestation, is the leading cause of illness and death in newborns. In the United States, more than 10% of infants are born prematurely, and this rate is substantially higher in lower-income, inner-city and Black populations. Prematurity associates with greatly increased risk of short- and long-term medical complications and can generate significant costs throughout the lives of affected children. Annual U.S. health care costs to manage short- and long-term prematurity complications are estimated to exceed $25 billion.Clinical interventions, including case management (increased patient outreach, education and specialist care), pharmacological treatment and their combination can provide benefit to pregnancies at higher risk for preterm birth. Early and sensitive risk detection, however, remains a challenge.We have developed and validated a proteomic biomarker risk predictor for early identification of pregnancies at increased risk of preterm birth. The ACCORDANT study modeled treatments with real-world patient data from a racially and ethnically diverse U.S. population to compare the benefits of risk predictor testing plus clinical intervention for higher-risk pregnancies versus no testing and standard care. Measured outcomes included neonatal and maternal length of hospital stay, associated costs and neonatal morbidity and mortality. The model projected improved outcomes and reduced costs across all subjects, including ethnic and racial minority populations, when predicted higher-risk pregnancies were treated using case management with or without pharmacological treatment. The biomarker risk predictor shows high potential to be a clinically important component of risk stratification for pregnant women, leading to tangible gains in reducing the impact of preterm birth.

Preliminary Findings from the Gulf War Women's Cohort: Reproductive and Children's Health Outcomes among Women Veterans.

Reproductive outcomes, such as preterm birth, miscarriage/stillbirth, and pre-eclampsia, are understudied in veterans, particularly among Gulf War veterans (GWVs). During deployment, women GWVs were exposed to toxicant and nontoxicant exposures that may be associated with adverse reproductive and developmental outcomes. The data come from a survey of 239 participants from northeastern and southern U.S. cohorts of women veterans. The questionnaire collected information about the service history, current and past general health, reproductive and family health, demographic information, and deployment exposures. Odds ratios were computed with 95% confidence intervals between exposures in theater and reproductive/children's health outcomes. GWVs experienced adverse reproductive outcomes: 25% had difficulty conceiving, and 31% had a pregnancy that ended in a miscarriage or stillbirth. Pregnancy complications were common among GWVs: 23% had a high-risk pregnancy, and 16% were diagnosed with pre-eclampsia. About a third of GWVs reported their children (38%) had a developmental disorder. Use of pesticide cream during deployment was associated with higher odds of all reproductive and developmental outcomes. The results demonstrate that GWVs experienced reproductive and children's health outcomes at potentially high rates, and exploratory analyses suggest pesticide exposure as associated with higher odds of adverse reproductive outcomes. Future longitudinal studies of women veterans should prioritize examining reproductive and children's health outcomes.

Better Estimation of Spontaneous Preterm Birth Prediction Performance through Improved Gestational Age Dating.

The clinical management of pregnancy and spontaneous preterm birth (sPTB) relies on estimates of gestational age (GA). Our objective was to evaluate the effect of GA dating uncertainty on the observed performance of a validated proteomic biomarker risk predictor, and then to test the generalizability of that effect in a broader range of GA at blood draw. In a secondary analysis of a prospective clinical trial (PAPR; NCT01371019), we compared two GA dating categories: both ultrasound and dating by last menstrual period (LMP) (all subjects) and excluding dating by LMP (excluding LMP). The risk predictor's performance was observed at the validated risk predictor threshold both in weeks 191/7-206/7 and extended to weeks 180/7-206/7. Strict blinding and independent statistical analyses were employed. The validated biomarker risk predictor showed greater observed sensitivity of 88% at 75% specificity (increases of 17% and 1%) in more reliably dated (excluding-LMP) subjects, relative to all subjects. Excluding dating by LMP significantly improved the sensitivity in weeks 191/7-206/7. In the broader blood draw window, the previously validated risk predictor threshold significantly stratified higher and lower risk of sPTB, and the risk predictor again showed significantly greater observed sensitivity in excluding-LMP subjects. These findings have implications for testing the performance of models aimed at predicting PTB.

Performance of a proteomic preterm delivery predictor in a large independent prospective cohort.

BACKGROUND: Preterm birth remains a common and devastating complication of pregnancy. There remains a need for effective and accurate screening methods for preterm birth. Using a proteomic approach, we previously discovered and validated (Proteomic Assessment of Preterm Risk study, NCT01371019) a preterm birth predictor comprising a ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin. OBJECTIVE: To determine the performance of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin to predict both spontaneous and medically indicated very preterm births, in an independent cohort distinct from the one in which it was developed. STUDY DESIGN: This was a prospective observational study (Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor, NCT02787213) at 18 sites in the United States. Women had blood drawn at 170/7 to 216/7 weeks' gestation. For confirmation, we planned to analyze a randomly selected subgroup of women having blood drawn between 191/7 and 206/7 weeks' gestation, with the results of the remaining study participants blinded for future validation studies. Serum from participants was analyzed by mass spectrometry. Neonatal morbidity and mortality were analyzed using a composite score by a method from the PREGNANT trial (NCT00615550, Hassan et al). Scores of 0-3 reflect increasing numbers of morbidities or length of neonatal intensive care unit stay, and 4 represents perinatal mortality. RESULTS: A total of 5011 women were enrolled, with 847 included in this planned substudy analysis. There were 9 preterm birth cases at <320/7 weeks' gestation and 838 noncases at ≥320/7 weeks' gestation; 21 of 847 infants had neonatal composite morbidity and mortality index scores of ≥3, and 4 of 21 had a score of 4. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was substantially higher in both preterm births at <320/7 weeks' gestation and there were more severe neonatal outcomes. The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio was significantly predictive of birth at <320/7 weeks' gestation (area under the receiver operating characteristic curve, 0.71; 95% confidence interval, 0.55-0.87; P=.016). Stratification by body mass index, optimized in the previous validation study (22

Stress and Anxiety are Associated with Lower Gestational Weight Gain in Hispanic Women.

OBJECTIVE: Prior studies indicate that inadequate and excessive gestational weight gain (GWG) are associated with poor maternal and infant outcomes, and that stress and anxiety may contribute to GWG. However, these studies often failed to use validated measures of stress and anxiety, measured only total GWG, and were limited to largely non-Hispanic White populations. We explored the association between stress and anxiety and GWG. METHODS: We used data from 1,308 participants in Proyecto Buena Salud, a prospective cohort of predominantly Puerto Rican women 18-40 years of age (2006-2012). We measured stress with the Perceived Stress Scale and anxiety with the State-Trait Anxiety Scale, and abstracted GWG from medical records. RESULTS: The average GWG was 31.0 ± 16.1 pounds. More than one-half of participants (51.8%) exceeded Institute of Medicine guidelines for GWG. After adjusting for age and pre-pregnancy body mass index, women in the highest quartiles of stress and anxiety in early pregnancy had approximately 4 lbs lower GWG (ß = -3.89; SE = 1.54; p = .012 and ß = -4.37; SE = 1.54; p = .005, respectively) as compared with those in the lowest quartiles. Similarly, women in the highest quartiles of mid/late pregnancy stress and anxiety had lower GWG (ß = -3.84 lbs; SE = 1.39; p = .006, and ß = -3.51 lbs; SE = 1.38; p = .011, respectively) and a lower rate of GWG in the second and third trimesters (ß = -0.117 lbs/week; SE = 0.044; p = .008 and ß = -0.116 lbs/week; SE = 0.043; p = .007, respectively), compared with those in the lowest quartiles. CONCLUSIONS: High stress and anxiety were associated with lower GWG. Interventions to decrease stress and anxiety during pregnancy should include counseling on maintaining healthy GWG.

Prenatal Depression and Risk of Short Interpregnancy Interval in a Predominantly Puerto Rican Population.

Background: Short interpregnancy interval (IPI) is associated with risk of adverse pregnancy outcomes; however, few studies have evaluated the role of depression as a risk factor for short IPI. Puerto Rican women in the United States experience disparities in adverse birth outcomes and have the highest birth rates. Methods: We analyzed the association between prenatal depressive symptoms and IPI in Proyecto Buena Salud, a prospective cohort of predominantly Puerto Rican women in Western Massachusetts (2006-2011). Depression was measured using the Edinburgh Postnatal Depression Scale (EPDS) in early, mid, and late pregnancy. We calculated follow-up time as the difference between the date of delivery of the index pregnancy and the last menstrual period of the subsequent pregnancy using medical records and billing data. We defined short IPI as ≤18 months. Results: Of 1262 eligible women, 35% (n = 440) had at least probable minor depression (EPDS scores ≥13) and 25% (n = 315) had probable major depression (EPDS scores ≥15). Participants were followed for a median of 3.7 years (interquartile range = 1.4-6.0 years) and 240 (20.6%) participants experienced a short IPI. After adjusting for risk factors, women with probable minor depression (adjusted odds ratio [aOR] = 1.39, 95% confidence interval [CI] = 1.02-1.88) and probable major depression (aOR = 1.42, 95% CI = 1.02-1.97) during pregnancy had increased odds of short IPI. Conclusions: Prenatal depressive symptoms were common in this Puerto Rican population and were associated with a modest increase in odds of short IPI. Further examination of the pathways through which mental health may affect IPI in vulnerable populations is warranted.

Obstetric Outcomes in Military Servicewomen: Emerging Knowledge, Considerations, and Gaps.

The number of women in the U.S. military is dramatically increasing. Similarly, the roles of active-duty women are greatly expanding, thus exposing them to new occupational risks. Determining the impact of pregnancy outcomes for women while in the military is difficult due to changing exposures over time, difficulty in utilizing appropriate comparison groups, and the lack of prospective investigations. Despite these limitations, it was concerning that the available data suggest that servicewomen delivering within 6 months of their first deployment have an increased preterm birth risk (adjusted odds ratio [aOR]: 2.1), and those with three prior deployments have an even greater risk (aOR: 3.8). Servicewomen also have an increased risk of hypertensive disorders with a rate of 13% compared with 5% in the general obstetric population. Furthermore, depression is higher for women who deploy after childbirth and are exposed to combat when compared with those who have not deployed since the birth of their child (aOR: 2.01). Due to the importance of this issue, prospective research designs are necessary to better understand and address the unique health care needs of this population.

Physical activity and depressive symptoms during pregnancy among Latina women: a prospective cohort study.

BACKGROUND: Latina women are at increased risk for antenatal depressive disorders, which are common during pregnancy and are associated with elevated risk for poor maternal health and birth outcomes. Physical activity is a potential mechanism to reduce the likelihood of depressive symptoms. The purpose of the study was to assess whether total and domain-specific physical activity in early pregnancy reduced risk for elevated antenatal depressive symptoms in mid-late pregnancy in a population of Latina women at high-risk for depression. METHODS: Data from 820 Latina participants in the prospective cohort study Proyecto Buena Salud was examined using multivariable logistic regression. Total, moderate/vigorous, and domain-specific physical activity (household/caregiving, occupational, sports/exercise, transportation) were assessed using the Pregnancy Physical Activity Questionnaire. The Edinburgh Postnatal Depression Scale was used to assess depressive symptoms and identify women with elevated symptoms indicative of at least probable minor depression and probable major depression. RESULTS: A total of 25.9% of participants experienced at least probable minor depression and 19.1% probable major depression in mid-late pregnancy. After adjusting for important risk factors, no significant associations were observed between total physical activity (4th Quartile vs.1st Quartile OR = 1.02, 95% CI = 0.61, 1.71; p-trend = 0.62) or meeting exercise guidelines in pregnancy (OR = 0.96, 95% CI = 0.65, 1.41) and at least probable minor depression; similarly, associations were not observed between these measures and probable major depression. There was a suggestion of increased risk of probable major depression with high levels of household/caregiving activity (4th Quartile vs 1st Quartile OR = 1.51, 95% CI = 0.93, 2.46), but this was attenuated and remained not statistically significant after adjustment. When we repeated the analysis among women who did not have elevated depressive symptoms in early pregnancy (n = 596), findings were unchanged, though a nonsignificant protective effect was observed for sport/exercise activity and probable major depression in fully adjusted analysis (OR = 0.63, 95% CI = 0.30, 1.33). CONCLUSION: Among Latina women at high-risk for antenatal depression, early pregnancy physical activity was not associated with elevated depressive symptoms in mid-to-late pregnancy.

The Health Behaviors of Ethnically Diverse Women at Increased Risk of Gestational Diabetes: The Behaviors Affecting Baby and You (B.A.B.Y.) Study.

Objectives Cigarette smoking, low physical activity, and sedentary behavior are modifiable risk factors for adverse pregnancy outcomes. However, only one study has evaluated predictors of these health risk behaviors among women at high risk for gestational diabetes mellitus (GDM). Therefore, our goal was to examine predictors of smoking, low physical activity, and sedentary behavior during pregnancy in an ethnically diverse high risk cohort. Methods This cross-sectional analysis utilized baseline data from the Behaviors Affecting Baby and You (B.A.B.Y.) study conducted among prenatal care patients at high risk for GDM (personal history of GDM or family history of diabetes and body mass index [BMI] ≥ 25 kg/m2). Smoking was assessed using questions from the Pregnancy Risk Assessment Monitoring System questionnaire and sedentary behavior (top vs. lower quartiles) and moderate/vigorous physical activity (bottom vs. upper quartile) via the Pregnancy Physical Activity Questionnaire. Results Participants (n = 400) enrolled at a mean of 12.4 (SD 3.6) weeks gestation. A total of 150 (44.1%) engaged in one, 37 (10.9%) in two, and 4 (1.2%) in three risk behaviors. Lower household income and not having children at home were each associated with a 2-6 fold increased odds of smoking, high sedentary behavior, and engaging in at least one risk behavior. Being married, Hispanic or of younger age was associated with a 2-6 fold reduced odds of smoking. BMI and personal history of GDM were not associated with risk behaviors. Conclusions for Practice Findings help characterize high risk groups and inform prenatal interventions targeting these health risk behaviors.

The Effect of an Exercise Intervention on Gestational Weight Gain: The Behaviors Affecting Baby and You (B.A.B.Y.) Study: A Randomized Controlled Trial.

PURPOSE: To examine the effect of a prenatal exercise intervention on gestational weight gain (GWG) and to update meta-analyses. DESIGN: Randomized controlled trial and meta-analysis. SETTING: Obstetrical practices in a Western Massachusetts hospital. PATIENTS: We analyzed 241 ethnically diverse pregnant participants at high risk for gestational diabetes in the Behaviors Affecting Baby and You (B.A.B.Y.) study. A total of 118 participants were randomized to an exercise intervention group and 123 to a comparison health and wellness intervention group. INTERVENTION: A 12-week individually tailored, motivationally matched program designed to increase the compliance with guidelines for exercise during pregnancy (30 min/day). MEASURES: The GWG and compliance with 2009 Institute of Medicine (IOM) guidelines for GWG abstracted from medical records. ANALYSIS: Unadjusted logistic regression, intent-to-treat. Results were added to the existing meta-analyses using a random effects model. RESULTS: Women randomized to the exercise group had a lower mean GWG than the comparison group (-0.97 kg, P value = .39) and were less likely to exceed IOM guidelines (odds ratio = 0.69, 95% confidence interval [CI] 0.34-1.40), but results were not statistically significant. Meta-analyses yielded a -0.63 kg (95% CI -1.17 to -0.08, P = .02) reduction in GWG and a 20% reduction in odds of exceeding IOM guidelines (95% CI 0.73 to 0.89) for the exercise intervention. CONCLUSION: Findings from this randomized trial among ethnically diverse women contribute to the results of meta-analyses supporting exercise as a means of attenuating GWG.

Prenatal Perceived Stress and Adverse Birth Outcomes Among Puerto Rican Women.

BACKGROUND: Preterm birth and low birthweight contribute substantially to the disproportionately high infant mortality rates experienced by Puerto Ricans in the United States. The purpose of this study was to examine whether the timing and pattern of prenatal psychosocial stress increased risk of adverse birth outcomes in this high-risk population. MATERIALS AND METHODS: Proyecto Buena Salud was a prospective cohort study conducted from 2006 to 2011 among predominantly Puerto Rican women. Participants (n = 1,267) were interviewed in early, mid-, and late pregnancy. We evaluated associations between early and mid-pregnancy stress (Perceived Stress Scale) and preterm birth and low birthweight, and stress at each pregnancy time point and small for gestational age (SGA). RESULTS: Elevated levels of perceived stress in mid-pregnancy increased risk for preterm birth and low birthweight in adjusted analyses, with a linear trend observed for each increasing quartile of stress (ptrend = 0.01). Women in the highest quartile of stress experienced three times the risk for preterm birth (odds ratio [OR] = 3.50, confidence interval [95% CI]: 1.38-8.87) and low birthweight (OR = 3.53, 95% CI = 1.27-9.86) compared with women in the lowest quartile. Early pregnancy stress was not associated with preterm birth or low birthweight. Increase in stress from early to late pregnancy increased risk for SGA (OR = 1.90, 95% CI = 1.01-3.59); no associations were found between stress at any timepoint and SGA. CONCLUSION: Elevated levels of mid-pregnancy perceived stress increased risk for preterm birth and low birthweight, and an increase in stress over the course of pregnancy increased risk for SGA in a population of predominantly Puerto Rican women.

Prepregnancy Body Mass Index, Gestational Weight Gain, and Odds of Cesarean Delivery in Hispanic Women.

OBJECTIVE: This study aimed to evaluate the association between prepregnancy body mass index (BMI), gestational weight gain (GWG), and cesarean delivery in Hispanics. METHODS: We examined these associations among 1,215 participants in Proyecto Buena Salud, a prospective cohort of Hispanic women studied from 2006 to 2011. Prepregnancy BMI, GWG, and the mode of delivery were abstracted from medical records. RESULTS: A quarter of the participants entered pregnancy with obesity, 23% delivered via cesarean, and 52% exceeded the Institute of Medicine guidelines for GWG. After adjusting for age, women with obesity had 2.03 times the odds of cesarean delivery compared with women with normal BMI (95% confidence interval [CI]: 1.46-2.82); findings remained significant after adjusting for GWG. Women with excessive total GWG had 1.49 times the odds of cesarean delivery (95% CI: 1.06-2.10) compared with women who gained within guidelines. An excessive rate of third trimester GWG (standard deviation [SD] change in GWG per week) increased the odds of cesarean delivery (odds ratio = 1.66; 95% CI: 1.05-2.62), while an excessive rate of first and third trimester GWG was not associated with increased odds. CONCLUSIONS: Obesity prior to pregnancy was associated with increased odds of cesarean delivery among Hispanics. Excessive GWG across pregnancy and an excessive rate of third trimester GWG were also associated with increased odds.

The impact of Bakri balloon tamponade on the rate of postpartum hysterectomy for uterine atony.

OBJECTIVE: Our objective was to evaluate the impact of uterine tamponade with a Bakri balloon on the rate of postpartum hysterectomy due to uterine atony. METHODS: We performed a retrospective cohort study of all deliveries >20 weeks gestation from January 2002 to March 2013 at Baystate Medical Center. Charts were reviewed to determine incidence of postpartum hysterectomy, Bakri balloon placement, uterine artery embolization (UAE) and the B-Lynch procedure. Patients with evidence of placenta accreta were excluded. The primary outcome was the change in rates of postpartum hysterectomy for uterine atony before and after the introduction of Bakri balloon tamponade, using chi-square testing. RESULTS: There were 48 767 deliveries during the study period, with 17 950 before and 30 817 after the introduction of the Bakri balloon. A total of 43 Bakri balloons were placed during the study period and 21 hysterectomies were performed for postpartum hemorrhage secondary to uterine atony, 14 before and 7 after the introduction of the Bakri balloon. This was consistent with a decrease in the rate of postpartum hysterectomy from 7.8/10 000 deliveries to 2.3/10 000 deliveries (p = 0.01). CONCLUSION: Our findings show that utilization of the Bakri balloon is associated with a decreased rate of postpartum hysterectomy.

Depression During Pregnancy and Adverse Birth Outcomes Among Predominantly Puerto Rican Women.

Objectives To examine associations between depression and preterm birth and small-for gestational age (SGA) among women of predominantly Puerto Rican descent, a population who experiences disparities in adverse birth outcomes and one of the highest infant mortality rates in the United States. Methods Proyecto Buena Salud (PBS) was a prospective cohort study conducted from 2006 to 2011 at a large tertiary care center in Western Massachusetts. Caribbean Islander (i.e., Puerto Rican and Dominican Republic) women were interviewed in early, mid and late pregnancy. Among 1262 participants, associations between depression, assessed using the Edinburgh Postnatal Depression Scale, and risk of preterm birth and small-for-gestational age (SGA) were evaluated. Results Women with at least probable minor depression [odds ratio (OR) = 1.77 (95% confidence interval (CI) = 1.02, 3.07)] or probable major depression [OR = 1.82 (95% CI = 1.01, 3.25)] in mid-pregnancy had an increased risk of SGA compared to non-depressed women in adjusted analyses. Borderline significant associations were observed between increasing levels of depressive symptom scores in early and mid-pregnancy [OR = 1.05 (95% CI = 1.00, 1.11) and OR = 1.04 (95% CI = 1.00, 1.09), respectively] and each additional trimester of exposure to probable major depression across mid- to late pregnancy [OR = 1.66 (95% CI = 1.00, 2.74)] and SGA. Late pregnancy depression was not associated with SGA; depression during pregnancy was not associated with preterm birth. Conclusions for Practice In this population of predominantly Puerto Rican women, mid-pregnancy depression increased risk for SGA. Findings can inform culturally appropriate, targeted interventions to identify and treat pregnant women with depression.

Are perinatal outcomes affected by blastocyst vitrification and warming?

BACKGROUND: Transfer of cryopreserved-warmed embryos into an appropriately prepared uterus unaffected by controlled ovarian hyperstimulation is common in the practice of in vitro fertilization. There is limited information on the effect of blastocyst vitrification and warming on perinatal outcomes. OBJECTIVE: We sought to determine if perinatal outcomes are affected after the transfer of vitrified-warmed blastocysts compared to the transfer of fresh blastocysts, by comparing preeclampsia rate, birthweight, percentage of low birthweight, and preterm delivery rate between embryo transfer types. STUDY DESIGN: We performed a retrospective database cohort study of 289 fresh and 109 vitrified-warmed blastocyst transfer cycles at an academic medical center. Cycles were performed from July 2, 2009, through Dec. 8, 2014, and included infants born at ≥20 weeks gestational age, excluding donor egg cycles. We examined the association between transfer type (fresh or vitrified-warmed) and proportion of deliveries complicated by preeclampsia, preterm delivery (gestational age <37 weeks), and low birthweight (<2500 g). We assessed associations using generalized linear models, both unadjusted and adjusted, for maternal age, newborn sex, diabetes status, and parity. RESULTS: We observed more pregnancies complicated by preeclampsia following vitrified-warmed transfers (7.6%) compared to fresh embryo transfers (2.6%) (P = .023) (adjusted odds ratio, 3.1; 95% confidence interval, 1.2-8.4). Newborns resulting from vitrified-warmed embryo transfer cycles were similar to those resulting from fresh embryo transfer cycles with regard to low birthweight (7.4% vs 5.3%, P = .421), mean birthweight (3443 vs 3431 g, P = .865), and preterm delivery rate (9.2% vs 8.7%, P = .869). CONCLUSION: We conclude that embryo vitrification with warming may affect some perinatal outcomes since preeclampsia is increased compared to fresh blastocyst transfer. However, other perinatal outcomes such as low birthweight and preterm delivery rate are not affected. Fresh blastocyst transfers should be considered when possible as they may reduce the incidence of preeclampsia.

Gestational Weight Gain, Body Mass Index, and Risk of Hypertensive Disorders of Pregnancy in a Predominantly Puerto Rican Population.

Objectives To prospectively evaluate the association between gestational weight gain (GWG), prepregnancy body mass index (BMI), and hypertensive disorders of pregnancy using the revised Institute of Medicine (IOM) Guidelines. Methods We examined these associations among 1359 participants in Proyecto Buena Salud, a prospective cohort study conducted from 2006 to 2011 among women from the Caribbean Islands. Information on prepregnancy BMI, GWG, and incident diagnoses of hypertension in pregnancy were based on medical record abstraction. Results Four percent (n = 54) of women were diagnosed with hypertension in pregnancy, including 2.6 % (n = 36) with preeclampsia. As compared to women who gained within IOM GWG guidelines (22.8 %), those who gained above guidelines (52.5 %) had an odds ratio of 3.82 for hypertensive disorders (95 % CI 1.46-10.00; ptrend = 0.003) and an odds ratio of 2.94 for preeclampsia (95 % CI 1.00-8.71, ptrend = 0.03) after adjusting for important risk factors. Each one standard deviation (0.45 lbs/week) increase in rate of GWG was associated with a 1.74 odds of total hypertensive disorders (95 % CI 1.34-2.27) and 1.86 odds of preeclampsia (95 % CI 1.37-2.52). Conclusions for Practice Findings from this prospective study suggest that excessive GWG is associated with hypertension in pregnancy and could be a potentially modifiable risk factor in this high-risk ethnic group.

Development and validation of a spontaneous preterm delivery predictor in asymptomatic women.

BACKGROUND: Preterm delivery remains the leading cause of perinatal mortality. Risk factors and biomarkers have traditionally failed to identify the majority of preterm deliveries. OBJECTIVE: To develop and validate a mass spectrometry-based serum test to predict spontaneous preterm delivery in asymptomatic pregnant women. STUDY DESIGN: A total of 5501 pregnant women were enrolled between 17(0/7) and 28(6/7) weeks gestational age in the prospective Proteomic Assessment of Preterm Risk study at 11 sites in the United States between 2011 and 2013. Maternal blood was collected at enrollment and outcomes collected following delivery. Maternal serum was processed by a proteomic workflow, and proteins were quantified by multiple reaction monitoring mass spectrometry. The discovery and verification process identified 2 serum proteins, insulin-like growth factor-binding protein 4 (IBP4) and sex hormone-binding globulin (SHBG), as predictors of spontaneous preterm delivery. We evaluated a predictor using the log ratio of the measures of IBP4 and SHBG (IBP4/SHBG) in a clinical validation study to classify spontaneous preterm delivery cases (<37(0/7) weeks gestational age) in a nested case-control cohort different from subjects used in discovery and verification. Strict blinding and independent statistical analyses were employed. RESULTS: The predictor had an area under the receiver operating characteristic curve value of 0.75 and sensitivity and specificity of 0.75 and 0.74, respectively. The IBP4/SHBG predictor at this sensitivity and specificity had an odds ratio of 5.04 for spontaneous preterm delivery. Accuracy of the IBP4/SHBG predictor increased using earlier case-vs-control gestational age cutoffs (eg, <35(0/7) vs ≥35(0/7) weeks gestational age). Importantly, higher-risk subjects defined by the IBP4/SHBG predictor score generally gave birth earlier than lower-risk subjects. CONCLUSION: A serum-based molecular predictor identifies asymptomatic pregnant women at risk of spontaneous preterm delivery, which may provide utility in identifying women at risk at an early stage of pregnancy to allow for clinical intervention. This early detection would guide enhanced levels of care and accelerate development of clinical strategies to prevent preterm delivery.

Early pregnancy vitamin D status and risk for adverse maternal and infant outcomes in a bi-ethnic cohort: the Behaviors Affecting Baby and You (B.A.B.Y.) Study.

Vitamin D deficiency is common during pregnancy and higher in Hispanic as compared with non-Hispanic white women. However, the association between vitamin D deficiency and adverse pregnancy outcomes remains unclear and may vary across ethnic groups, in part because of genetic variation in the metabolism of vitamin D. Few studies have included Hispanic women. Therefore, we investigated this association among 237 participants in the Behaviors Affecting Baby and You Study, a randomised trial of an exercise intervention among ethnically diverse prenatal care patients in Massachusetts. Baseline serum 25-hydroxyvitamin D (25(OH)D) was measured at 15·2 (sd 4·7) weeks' gestation. Information on adverse pregnancy outcomes was abstracted from medical records. Mean 25(OH)D was 30·4 (sd 12·0) ng/ml; 53·2 % of participants had insufficient (<30 ng/ml) and 20·7 % had deficient (<20 ng/ml) 25(OH)D levels. After adjusting for month of blood draw, gestational age at blood draw, gestational age at delivery, age, BMI and Hispanic ethnicity, women with insufficient and deficient vitamin D had infants with birth weights 139·74 (se 69·16) g (P=0·045) and 175·52 (se 89·45) g (P=0·051) lower compared with women with sufficient vitamin D levels (≥30 ng/ml). Each 1 ng/ml increase in 25(OH)D was associated with an increased risk for gestational diabetes mellitus among Hispanic women only (relative risk 1·07; 95 % CI 1·03, 1·11) in multivariable analysis. We did not observe statistically significant associations between maternal vitamin D status and other pregnancy outcomes. Our findings provide further support for an adverse impact of vitamin D deficiency on birth weight in Hispanic women.

Proyecto Mamá: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocol.

BACKGROUND: The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women. METHODS/DESIGN: Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period. DISCUSSION: Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations. TRIAL REGISTRATION: NCT01868230 May 29, 2013.