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

Abstract 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

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\u27 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\u27s exact test for neonatal morbidity/mortality (significance, p \u3c .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\u27 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

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<body mass index≤37 kg/m2), resulted in an area under the receiver operating characteristic curve of 0.76 (95% confidence interval, 0.59–0.93; P=.023). The ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio predicted neonatal outcomes with respective area under the receiver operating characteristic curve of 0.67 (95% confidence interval, 0.57–0.77; P=.005) and 0.78 (95% confidence interval, 0.63–0.93; P=.026) for neonatal composite morbidity and mortality scores of ≥3 or 4. In addition, the ratio of insulin-like growth factor-binding protein 4 to sex hormone binding globulin significantly stratified neonates with increased length of hospital stay (log rank P=.023). Conclusion We confirmed in an independent cohort the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin ratio as a predictor of very preterm birth, with additional prediction of increased length of neonatal hospital stay and increased severity of adverse neonatal outcomes. Potential uses of the ratio of insulin-like growth factor-binding protein 4 to sex hormone-binding globulin predictor may be to risk stratify patients for implementation of preterm birth preventive strategies and direct patients to appropriate levels of care

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

Abstract 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

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

Does early second-trimester sonography predict adverse perinatal outcomes in monochorionic diamniotic twin pregnancies?

OBJECTIVES: To determine whether intertwin discordant abdominal circumference, femur length, head circumference, and estimated fetal weight sonographic measurements in early second-trimester monochorionic diamniotic twins predict adverse obstetric and neonatal outcomes. METHODS: We conducted a multicenter retrospective cohort study involving 9 regional perinatal centers in the United States. We examined the records of all monochorionic diamniotic twin pregnancies with two live fetuses at the 16- to 18-week sonographic examination who had serial follow-up sonography until delivery. The intertwin discordance in abdominal circumference, femur length, head circumference, and estimated fetal weight was calculated as the difference between the two fetuses, expressed as a percentage of the larger using the 16- to 18-week sonographic measurements. An adverse composite obstetric outcome was defined as the occurrence of 1 or more of the following in either fetus: intrauterine growth restriction, twin-twin transfusion syndrome, intrauterine fetal death, abnormal growth discordance (≥20% difference), and very preterm birth at or before 28 weeks. An adverse composite neonatal outcome was defined as the occurrence of 1 or more of the following: respiratory distress syndrome, any stage of intraventricular hemorrhage, 5-minute Apgar score less than 7, necrotizing enterocolitis, culture-proven early-onset sepsis, and neonatal death. Receiver operating characteristic and logistic regression-with-generalized estimating equation analyses were constructed. RESULTS: Among the 177 monochorionic diamniotic twin pregnancies analyzed, intertwin abdominal circumference and estimated fetal weight discordances were only predictive of adverse composite obstetric outcomes (areas under the curve, 79% and 80%, respectively). Receiver operating characteristic curves showed that intertwin discordances in abdominal circumference, femur length, head circumference, and estimated fetal weight were not acceptable predictors of twin-twin transfusion syndrome or adverse neonatal outcomes. CONCLUSIONS: In our cohort, only second-trimester abdominal circumference and estimated fetal weight discordances in monochorionic diamniotic twin pregnancies were predictive of adverse composite obstetric outcomes. Twin-twin transfusion syndrome and adverse neonatal outcomes were not predicted by any of the intertwin discordances measured