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Information is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases. Between 2004 and 2016, the Organization of Teratology Information Specialists Research Center at the University of California San Diego conducted a prospective controlled observational cohort study in 602 pregnant women who had or had not taken adalimumab. Women in the adalimumab-exposed cohort had received at least one dose of the drug in the first trimester for the treatment of rheumatoid arthritis or Crohn's Disease (N = 257). Women in the disease comparison cohort had not used adalimumab in pregnancy (N = 120). Women in the healthy comparison cohort had no rheumatic or inflammatory bowel diseases (N = 225). Women and their infants were followed to one year postpartum with maternal interviews, medical records abstraction, and physical examinations. Study outcomes were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, pre and post-natal growth deficiency, serious or opportunistic infections and malignancies. 42/602 (7.0%) of pregnancies were lost-to-follow-up. 22/221 (10.0%) in the adalimumab-exposed cohort had a live born infant with a major birth defect compared to 8/106 (7.5%) in the diseased unexposed cohort (adjusted odds ratio 1.10, 95% confidence interval [CI] 0.45 to 2.73). Women in the adalimumab-exposed cohort were more likely to deliver preterm compared to the healthy cohort (adjusted hazard ratio [aHR] 2.59, 95% CI 1.22 to 5.50), but not compared to the diseased unexposed cohort (aHR 0.82, 95% CI 0.66 to 7.20). No significant increased risks were noted with adalimumab exposure for any other study outcomes. Adalimumab exposure in pregnancy compared to diseased unexposed pregnancies was not associated with an increased risk for any of the adverse outcomes examined. Women with rheumatoid arthritis or Crohn's Disease were at increased risk of preterm delivery, irrespective of adalimumab exposure.

Fetal alcohol spectrum disorders (FASD) are difficult to diagnose since many heavily exposed infants, at risk for intellectual disability, do not exhibit craniofacial dysmorphology or growth deficits. Consequently, there is a need for biomarkers that predict disability. In both animal models and human studies, alcohol exposure during pregnancy resulted in significant alterations in circulating microRNAs (miRNAs) in maternal blood. In the current study, we asked if changes in plasma miRNAs in alcohol-exposed pregnant mothers, either alone or in conjunction with other clinical variables, could predict infant outcomes. Sixty-eight pregnant women at two perinatal care clinics in western Ukraine were recruited into the study. Detailed health and alcohol consumption histories, and 2nd and 3rd trimester blood samples were obtained. Birth cohort infants were assessed by a geneticist and classified as unexposed (UE), heavily prenatally exposed and affected (HEa) or heavily exposed but apparently unaffected (HEua). MiRNAs were assessed in plasma samples using qRT-PCR arrays. ANOVA models identified 11 miRNAs that were all significantly elevated in maternal plasma from the HEa group relative to HEua and UE groups. In a random forest analysis classification model, a combination of high variance miRNAs, smoking history and socioeconomic status classified membership in HEa and UE groups, with a misclassification rate of 13%. The RFA model also classified 17% of the HEua group as UE-like, whereas 83% were HEa-like, at least at one stage of pregnancy. Collectively our data indicate that maternal plasma miRNAs predict infant outcomes, and may be useful to classify difficult-to-diagnose FASD subpopulations.

Background Evidence suggests that cytokine imbalances may be at the root of deficits that occur in numerous neurodevelopmental disorders, including schizophrenia and autism spectrum disorder. Notably, while clinical studies have demonstrated maternal cytokine imbalances with alcohol consumption during pregnancy—and data from animal models have identified immune disturbances in alcohol-exposed offspring—to date, immune alterations in alcohol-exposed children have not been explored. Thus, here we hypothesized that perturbations in the immune environment as a result of prenatal alcohol exposure will program the developing immune system, and result in immune dysfunction into childhood. Due to the important role of cytokines in brain development/function, we further hypothesized that child immune profiles might be associated with their neurodevelopmental status. Methods As part of a longitudinal study in Ukraine, children of mothers reporting low/no alcohol consumption or moderate-to-heavy alcohol consumption during pregnancy were enrolled in the study and received neurodevelopmental assessments. Group stratification was based on maternal alcohol consumption and child neurodevelopmental status resulting in the following groups: A/TD, alcohol-consuming mother, typically developing child; A/ND, alcohol-consuming mother, neurodevelopmental delay in the child; C/TD, control mother (low/no alcohol consumption), typically development child; and C/ND, control mother, neurodevelopmental delay in the child. Forty cytokines/chemokines were measured in plasma and data were analyzed using regression and constrained principle component analysis. Results Analyses revealed differential cytokine network activity associated with both prenatal alcohol exposure and neurodevelopmental status. Specifically, alcohol-exposed children showed activation of a cytokine network including eotaxin-3, eotaxin, and bFGF, irrespective of neurodevelopmental status. However, another cytokine network was differentially activated based on neurodevelopmental outcome: A/TD showed activation of MIP-1β, MDC, and MCP-4, and inhibition of CRP and PlGF, with opposing pattern of activation/inhibition detected in the A/ND group. By contrast, in the absence of alcohol-exposure, activation of a network including IL-2, TNF-β, IL-10, and IL-15 was associated with neurodevelopmental delay. Conclusions Taken together, this comprehensive assessment of immune markers allowed for the identification of unique immune milieus that are associated with alcohol exposure as well as both alcohol-related and alcohol-independent neurodevelopmental delay. These findings are a critical step towards establishing unique immune biomarkers for alcohol-related and alcohol-independent neurodevelopmental delay.

Maternal lipid profiles during pregnancy are associated with risk for preterm birth. This study investigates the association between maternal dyslipidemia and subsequent preterm birth among pregnant women in the state of California. Births were identified from California birth certificate and hospital discharge records from 2007-2012 (N = 2,865,987). Preterm birth was defined as <37 weeks completed gestation and dyslipidemia was defined by diagnostic codes. Subtypes of preterm birth were classified as preterm premature rupture of membranes (PPROM), spontaneous labor, and medically indicated, according to birth certificate data and diagnostic codes. The association between dyslipidemia and preterm birth was tested with logistic regression. Models were adjusted for maternal age at delivery, race/ethnicity, hypertension, pre-pregnancy body mass index, insurance type, and education. Maternal dyslipidemia was significantly associated with increased odds of preterm birth (adjusted OR: 1.49, 95%CI: 1.39, 1.59). This finding was consistent across all subtypes of preterm birth, including PPROM (adjusted OR: 1.54, 95%CI: 1.34, 1.76), spontaneous (adjusted OR: 1.51, 95%CI: 1.39, 1.65), and medically indicated (adjusted OR: 1.454, 95%CI: 1.282, 1.649). This study suggests that maternal dyslipidemia is associated with increased risk for all types of preterm birth.

This case–control study demonstrates a significant association between persistent pulmonary hypertension of the newborn and the use of selective serotonin-reuptake inhibitors (SSRIs) during the second half of pregnancy. There was no significant association between this outcome and the use of SSRIs during the first half of pregnancy or the use of non-SSRI antidepressants during pregnancy. This study demonstrated a significant association between persistent pulmonary hypertension of the newborn and the use of selective serotonin-reuptake inhibitors during the second half of pregnancy. Persistent pulmonary hypertension of the newborn (PPHN) occurs in an estimated 1 or 2 infants per 1000 live births and is associated with substantial morbidity and mortality. 1 – 4 Despite treatment, 10 to 20 percent of affected infants will not survive. 4 , 5 Newborns with PPHN are typically full-term or near-term infants without associated congenital anomalies who present shortly after birth with severe respiratory failure requiring intubation and mechanical ventilation. 6 This disruption of the normal fetal-to-neonatal circulatory transition is characterized by postnatal persistence of elevated pulmonary vascular resistance, resulting in right-to-left shunting of blood through fetal channels (the patent ductus arteriosus, foramen . . .

Circulating miRNAs the in blood are promising biomarkers for predicting pregnancy complications and adverse birth outcomes. Previous work identified 11 gestationally elevated maternal circulating miRNAs ( HEa miRNAs) that predicted infant growth deficits following prenatal alcohol exposure and regulated epithelial–mesenchymal transition in the placenta. Here we show that a single intravascular administration of pooled murine-conserved HEa miRNAs to pregnant mice on gestational day 10 (GD10) attenuates umbilical cord blood flow during gestation, explaining the observed intrauterine growth restriction (IUGR), specifically decreased fetal weight, and morphometric indices of cranial growth. Moreover, RNAseq of the fetal portion of the placenta demonstrated that this single exposure has lasting transcriptomic changes, including upregulation of members of the Notch pathway ( Dll4 , Rfng , Hey1 ), which is a pathway important for trophoblast migration and differentiation. Weighted gene co-expression network analysis also identified chemokine signaling, which is responsible for regulating immune cell-mediated angiogenesis in the placenta, as an important predictor of fetal growth and head size. Our data suggest that HEa miRNAs perturb the expression of placental genes relevant for angiogenesis, resulting in impaired umbilical cord blood flow and subsequently, IUGR.

Objectives Fetal alcohol spectrum disorders are more common in disadvantaged populations. Environmental factors, like suboptimal nutrition, may potentiate the developmental effects of prenatal alcohol exposure. To evaluate the impact of micronutrients, including choline, on reduction of effects of exposure, we examined timing and dose of alcohol and effects of nutritional supplementation at two OMNI-Net sites in Western Ukraine that included high and low risk individuals. Methods Alcohol-using and nondrinking women were randomized to one of three multivitamin/mineral supplement groups: none, multivitamins/minerals (MVM), and multivitamin/minerals plus choline. Children (N = 367) were tested at 6 months with the Bayley Scales of Infant Development (2nd ED) yielding standard scores for Mental Development Index (MDI), Psychomotor Development Index (PDI) and Behavior. Results Generalized linear modeling was used: (1) for factorial analysis of effects of alcohol group, multivitamin/minerals, and choline supplementation; and (2) to examine the relationship between amount and timing of alcohol (ounces of absolute alcohol/day [ozAA/day] peri-conception and on average in the second trimester) and MVM supplementation on developmental outcomes while controlling sex, social class, and smoking. MDI was significantly impacted by peri-conceptual alcohol dose ( χ ( 1 ) 2 = 8.54 , p  < .001) with more alcohol associated with lower scores and males more negatively affected than females ( χ ( 3 ) 2 = 11.04 , p  < .002). Micronutrient supplementation had a protective effect; those receiving supplements performed better ( χ ( 1 ) 2 = 8.03 , p  < .005). The PDI motor scores did not differ by group but were affected by peri-conceptual alcohol dose ( χ ( 1 ) 2 = 4.17 , p  < .04). Conclusions for Practice Multivitamin/mineral supplementation can reduce the negative impact of alcohol use during pregnancy on specific developmental outcomes.

Population-based databases are valuable for perinatal research. The California Department of Health Care Access and Information (HCAI) created a linked birth file covering the years 1991 through 2012. This file includes birth and fetal death certificate records linked to the hospital discharge records of the birthing person and infant. In 2019, the University of California Study of Outcomes in Mothers and Infants received approval to create similar linked birth files for births from 2011 onward, with 2 years of overlapping birth files to allow for linkage comparison. This paper aims to describe the University of California Study of Outcomes in Mothers and Infants linkage methodology, examine the linkage quality, and discuss the benefits and limitations of the approach. Live birth and fetal death certificates were linked to hospital discharge records for California infants between 2005 and 2020. The linkage algorithm includes variables such as birth hospital and date of birth, and linked record selection is made based on a \"link score.\" The complete file includes California Vital Statistics and HCAI hospital discharge records for the birthing person (1 y before delivery and 1 y after delivery) and infant (1 y after delivery). Linkage quality was assessed through a comparison of linked files and California Vital Statistics only. Comparisons were made to previous linked birth files created by the HCAI for 2011 and 2012. Of the 8,040,000 live births, 7,427,738 (92.38%) California Vital Statistics live birth records were linked to HCAI records for birthing people, 7,680,597 (95.53%) birth records were linked to HCAI records for the infant, and 7,285,346 (90.61%) California Vital Statistics birth records were linked to HCAI records for both the birthing person and the infant. The linkage rates were 92.44% (976,526/1,056,358) for Asian and 86.27% (28,601/33,151) for Hawaiian or Pacific Islander birthing people. Of the 44,212 fetal deaths, 33,355 (75.44%) had HCAI records linked to the birthing person. When assessing variables in both California Vital Statistics and hospital records, the percentage was greatest when using both sources: the rates of gestational diabetes were 4.52% (329,128/7,285,345) in the California Vital Statistics records, 8.2% (597,534/7,285,345) in the HCAI records, and 9.34% (680,757/7,285,345) when using both data sources. We demonstrate that the linkage strategy used for this data platform is similar in linkage rate and linkage quality to the previous linked birth files created by the HCAI. The linkage provides higher rates of crucial variables, such as diabetes, compared to birth certificate records alone, although selection bias from the linkage must be considered. This platform has been used independently to examine health outcomes, has been linked to environmental datasets and residential data, and has been used to obtain and examine maternal serum and newborn blood spots.

•Information is needed on safety of pandemic H1N1 influenza vaccines in pregnancy.•1032 exposed pregnant women were followed to pregnancy outcome, 2009–2012.•No increases in birth defects, spontaneous abortion or growth restriction were seen.•Vaccinated women on average delivered 3 days earlier than non-vaccinated.•This study adds to the reassuring literature about pH1N1 vaccines in pregnancy. There is a need for additional information on the fetal risks and relative safety of the pandemic H1N1 monovalent or trivalent influenza (pH1N1)-containing vaccines in women exposed during pregnancy. To assess risks and relative safety of the pH1N1-containing vaccines, we conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women residing in the U.S. or Canada who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. For exposure to the pH1N1 vaccine, adjusted relative risks (RRs) and 95% confidence intervals (CIs) were estimated for major birth defects and infants small for gestational age. Adjusted hazard ratios (HRs) and 95% CIs were estimated for spontaneous abortion and preterm delivery for time-varying exposure. There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed (adjusted RR 0.79, 95% CI 0.26–2.42). The HR for spontaneous abortion was not elevated (adjusted HR 0.92, 95% CI 0.31–2.72). Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy (3.28, 95% CI 1.25–8.63), specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. Adjusted RRs for small for gestational age infants on weight and length approximated 1.0. For the 2009–12 influenza seasons combined, we found no meaningful evidence of increased RR or HR for major birth defects, spontaneous abortion, or small for gestational age infants. There was some evidence of an increased HR for preterm delivery following pH1N1-influenza vaccine exposure; however the decrease in gestational age on average was approximately three days.

► Pregnant women's health beliefs were key predictors of seasonal flu vaccination. ► Emotions like worry and anticipated regret were especially strong predictors. ► Beliefs about influential others and a doctor's reminder were also important. Guidelines recommend influenza vaccination for pregnant women, but vaccine uptake in this population is far below the goal set by Healthy People 2020. The purpose of this study was to examine predictors of seasonal influenza vaccination among pregnant women. Between 2009 and 2012, the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) conducted a prospective cohort study of influenza vaccine safety among pregnant women in the US and Canada that oversampled vaccinated women. Data for the present paper are from an additional cross-sectional telephone survey completed during the 2010–2011 influenza season. We examined predictors of influenza vaccination, focusing on Health Belief Model (HBM) constructs. We surveyed 199 pregnant women, 81% of whom had received a seasonal influenza vaccine. Vaccination was more common among women who felt more susceptible to influenza (OR=1.82, 95% CI 1.10–3.01), who perceived greater vaccine effectiveness (OR=3.92, 95% CI 1.48–10.43), and whose doctors recommended they have flu shots (OR=3.06, 95% CI 1.27–7.38). Those who perceived greater barriers of influenza vaccination had lower odds of vaccination (OR=0.19, 95% CI 0.05–0.75). Perceived social norms, anticipated inaction regret, and worry also predicted uptake, though demographic characteristics of respondents did not. The HBM provides a valuable framework for exploring influenza vaccination among pregnant women. Our results suggest several potential areas of intervention to improve vaccination rates.