Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.
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ABSTRACT:
SUBMITTER: Sebikari D
PROVIDER: S-EPMC6702964 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.
Sebikari Dorothy D Farhad Mona M Fenton Terry T Owor Maxensia M Stringer Jeffrey S A JSA Qin Min M Chakhtoura Nahida N Chi Benjamin H BH Saidi Friday F Nevrekar Neetal N Violari Avy A Chipato Tsungai T McIntyre James A JA Moodley Dhayendre D Taha Taha E TE Theron Gerhard G Fowler Mary Glenn MG
Journal of acquired immune deficiency syndromes (1999) 20190801 5
<h4>Background</h4>In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudin ...[more]
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Project description:BackgroundSignificant and persistent racial and income disparities in birth outcomes exist in the US. The analyses in this manuscript examine whether adverse birth outcome time trends and associations between area-level variables and adverse birth outcomes differ by urban-rural status.MethodsAlabama births records were merged with ZIP code-level census measures of race, poverty, and rurality. B-splines were used to determine long-term preterm birth (PTB) and low birth weight (LBW) trends by rurality. Logistic regression models were used to examine differences in the relationships between ZIP code-level percent poverty or percent African-American with either PTB or LBW. Interactions with rurality were examined.ResultsPopulation dense areas had higher adverse birth outcome rates compared to other regions. For LBW, the disparity between population dense and other regions increased during the 1991-2005 time period, and the magnitude of the disparity was maintained through 2010. Overall PTB and LBW rates have decreased since 2006, except within isolated rural regions. The addition of individual-level socioeconomic or race risk factors greatly attenuated these geographical disparities, but isolated rural regions maintained increased odds of adverse birth outcomes. ZIP code-level percent poverty and percent African American both had significant relationships with adverse birth outcomes. Poverty associations remained significant in the most population-dense regions when models were adjusted for individual-level risk factors.ConclusionsPopulation dense urban areas have heightened rates of adverse birth outcomes. High-poverty African American areas have higher odds of adverse birth outcomes in urban versus rural regions. These results suggest there are urban-specific social or environmental factors increasing risk for adverse birth outcomes in underserved communities. On the other hand, trends in PTBs and LBWs suggest interventions that have decreased adverse birth outcomes elsewhere may not be reaching isolated rural areas.
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Project description:Preterm birth is a major public health problem, especially in Puerto Rico where the rates are among the highest observed worldwide, reaching 18% in 2011. The Puerto Rico Testsite for Exploring Contamination Threats (PROTECT) study is an ongoing investigation of environmental factors that contribute to this condition. In the present analysis, we sought to examine common risk factors for preterm birth and other adverse birth outcomes which have not been characterized previously in this unique population. Pregnant women from the PROTECT cohort are recruited from the heavily contaminated Northern coast of the island of Puerto Rico and are free of pre-existing conditions like diabetes. We examined associations between basic demographic, behavioral (e.g., tobacco and alcohol use), and pregnancy (e.g., season and year of delivery) characteristics as well as municipality of residence in relation to preterm birth (<37 weeks gestation), postterm birth (?41 weeks gestation), and small and large for gestational age in univariate and multivariate logistic regression models. Between 2011 and 2017, 1028 live singleton births were delivered as part of the PROTECT cohort. Of these, 107 (10%) were preterm. Preterm birth rates were higher among women with low socioeconomic status, as indicated by education level and income, and among women with high pre-pregnancy body mass index (BMI). Odds ratios of small for gestational age delivery were higher for women who reported tobacco use in pregnancy and lower for women who delivered in the hurricane and dengue season (July-October). Overall, in pregnant women residing in Puerto Rico, socioeconomic status was associated with preterm birth but few other factors were associated with this or other adverse outcomes of pregnancy. Research to understand environmental factors that could be contributing to the preterm birth epidemic in Puerto Rico is necessary.
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Project description:BackgroundMany maternal factors are known to be associated with adverse birth outcomes, but studies about paternal factors yielded inconsistent conclusions. The study was to assess whether paternal factors are associated with low birth weight (LBW), preterm birth (PTB), and small for gestational age (SGA).MethodsA birth cohort study was conducted in 2010-2012 at the Gansu Provincial Maternity and Child Care Hospital, the largest maternity and childcare hospital in Lanzhou, China. Paternal age, ethnicity, educational level, height, weight, smoking, and drinking were collected. Birth outcomes and pregnancy complications were extracted from the medical records.ResultsDuring the study period, 10,121 participants were included; the overall prevalence of LBW, PTB, and SGA was 7.2, 9.9, and 7.8%, respectively. Paternal higher height (OR?=?0.64 95%CI: 0.49, 0.83), higher weight (P for trend <?0.001), and higher BMI (P for trend <?0.001) could decrease the rate of LBW. Paternal higher education (OR?=?0.55, 95%CI: 0.43, 0.71) and higher weight (P for trend <?0.001,) were associated with lower rate of PTB. Fathers who smoked more than 6 pack-years were associated with PTB (OR?=?1.31, 95%CI: 1.07, 1.61). Paternal BMI >?23.9?kg/m2 (P for trend <?0.001,) and paternal education which above college (OR?=?0.61, 95%CI: 0.50, 0.82) were associated with a lower rate of SGA.ConclusionPaternal low education is independently associated with PTB and SGA. Paternal heavy smoking is associated with PTB. Low paternal weight/BMI is independently associated with LBW, PTB, and SGA.
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Project description:BackgroundIt is unclear whether confounding accounts for the increased risk of preterm birth and small for gestational age (SGA) birth in opioid analgesic exposed pregnancies.MethodsUsing universal coverage health data for Ontario, we assembled a cohort of mother-infant pairs without opioid use disorder (627,172 pregnancies and 509,522 women). We estimated risk ratios (RRs) between opioid analgesics and preterm birth, SGA birth, and stillbirth; neonatal abstinence syndrome was a secondary outcome. We used high-dimensional propensity scores and sensitivity analyses for confounding adjustment.Results4% of pairs were exposed, mainly to codeine (2%), morphine (1%), and oxycodone (1%). Compared with unexposed, the adjusted risk of preterm birth was higher with any (1.3, 95% confidence interval [CI] = 1.2, 1.3), first- (RR: 1.2, 95% CI = 1.2, 1.3), and second-trimester (RR: 1.3, 95% CI = 1.2, 1.4) opioid analgesic exposure. Preterm birth risk was higher for first- and second-trimester codeine, morphine, and oxycodone exposure, and for third-trimester morphine. There was a small increase in SGA with first-trimester exposure to any opioid analgesic or to codeine. Exposed pregnancies had an elevated stillbirth risk with any (RR: 1.6, 95% CI = 1.4, 1.8), first- and second-trimester exposure. Few infants had neonatal abstinence syndrome (N = 143); the risk was higher in exposed (RR: 3.6, 95% CI = 2.1, 6.0). In sensitivity analyses of unmeasured confounding, an elevated risk in exposed pregnancies persisted for preterm birth but not SGA.ConclusionsOpioid analgesic-exposed pregnancies had a small increased risk of preterm birth and possibly stillbirth after accounting for confounding by indication and sociodemographic factors.
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Project description:Introduction Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth outcomes that are prevalent in low-income and middle-income settings such as the Pacific Island region. It is widely accepted that the excess burden of adverse birth outcomes is attributable to socioeconomic and environmental factors that predispose families to excess risk. Our review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island region and to identify the risk factors of adverse birth outcomes in the Pacific Island region. Methods This scoping review will follow the five-staged Arksey and O’Malley’s framework and consultation with Solomon Islands’ health stakeholders. A preliminary literature review was undertaken to understand the scope of the review. We will use Medical Subject Heading and keyword terms for adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest and Springer Link databases for articles published from 1 January 2000. The subsequent searches will be undertaken via Google Scholar and the internet browser to world health organisation and regional health organisations for published and unpublished reports on non-indexed studies. All articles retrieved will be managed with EndNote software. Eligible studies will be screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for final selection. In the charting phase, we will extract the data into Excel spreadsheets. The results will be presented as numerical and thematic summaries that map risk factors and prevalence to the population and cultures of the Pacific Island region. Ethics and dissemination Formal ethical approval is not required as primary or administrative data will not be collected. However, we will seek ethics approval for the stakeholder consultation from the Research Office of Curtin University and the Solomon Islands. The findings of this study will be published in peer-reviewed journals and presented in national and regional conferences and disseminated to stakeholders. Ethics approval There will be no direct contact with human or patients in the case of the scoping review; therefore, no ethics will be required. However, we will seek ethical approval from the Research Ethics Office of Curtin University and the Health Research and Ethics Committee in the Solomon Islands for stakeholder consultation. Dissemination will be made through regional conferences and publication in peer-reviewed journals.
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Project description:OBJECTIVE:To compare the effect of preconception initiation of zidovudine, lamivudine, nevirapine (ZDV/3TC/NVP) versus tenofovir, emtricitabine, efavirenz (TDF/FTC/EFV) on adverse birth outcomes. DESIGN:Emulation of a hypothetical (target) trial using a birth surveillance study in Botswana during an era of CD4-based antiretroviral therapy (ART) initiation. METHODS:In women who initiated ART less than 3 years from HIV diagnosis, conceived 0.5-5 years after ART initiation, and delivered at least 24-week gestation, we estimated risk ratios for stillbirth, preterm delivery (<37 weeks), very preterm delivery (<32 weeks), small-for-gestational-age (SGA) (<10 percentile), very SGA (<3 percentile), and any adverse or severe birth outcome for first-line ZDV/3TC/NVP versus TDF/FTC/EFV. We conducted a historical comparison in women who initiated TDF/FTC/EFV in 2012-2015 and ZDV/3TC/NVP in 2004-2011, and a contemporaneous comparison in an era of overlapping use from 2009 to 2013. RESULTS:In the historical comparison, 1108 women initiated TDF/FTC/EFV and 637 initiated ZDV/3TC/NVP. In the contemporaneous comparison, 1052 initiated TDF/FTC/EFV and 298 initiated ZDV/3TC/NVP. TDF/FTC/EFV initiators were younger and more likely to be nulliparous than ZDV/3TC/NVP initiators in both comparisons. In the historical comparison, the adjusted risk ratios (95% confidence interval) comparing ZDV/3TC/NVP with TDF/FTC/EFV were 2.95 (1.76, 4.96) for stillbirth, 1.40 (1.17, 1.67) for preterm delivery, 2.58 (1.70, 3.91) for very preterm delivery, 1.96 (1.64, 2.34) for SGA, 2.32 (1.73, 3.09) for very SGA, 1.54 (1.38, 1.72) for any adverse birth outcome, and 2.20 (1.76, 2.75) for any severe birth outcome, and were similar in the contemporaneous comparison. CONCLUSION:Preconception initiation of ZDV/3TC/NVP compared with TDF/FTC/EFV may increase the risk of adverse birth outcomes.
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Project description:BACKGROUND:The prevalence of preterm birth and low birth weight has been increasing slightly in recent years. A few studies have suggested that psychosocial stress during pregnancy may increase risk for these adverse birth outcomes. To extend those observations, we analyzed various major life event stressors separately and cumulatively as potential risk factors for preterm birth and low birth weight using granular categories of each outcome in a large, population-based study. Additionally, we assessed if greater social support buffered any effects. METHODS:Data were from a nested prevalence study of 4395 women in the National Birth Defects Prevention Study who delivered live-born non-malformed infants (controls) between 2006 and 2011. Participants completed a standardized, computer-assisted interview between 6?weeks and 24?months after delivery that included questions on stress and social support from 3?months before pregnancy to the 3rd month of pregnancy. Cumulative stress and support indices were also calculated. Preterm birth was divided into "early preterm" (<?32?weeks), "late preterm" (32-36?weeks) and "term." Low birthweight was divided into "very low birth weight" (<?1500?g), "low birth weight" (1500-2499?g) and "normal birth weight" (?2500?g). Relative risks and 95% confidence intervals (95% CI) were calculated using Poisson regression. RESULTS:For women reporting relationship difficulties, there was a suggestive risk of early preterm birth (RR: 1.9, 95%CI: 0.9-3.9) and very low birthweight (RR: 2.0, 95%CI: 0.9-4.4). For women reporting that they or someone close to them were victims of abuse, violence, or crime, there was an increased risk of low birthweight (RR: 1.8, 95%CI: 1.1-2.7) and late preterm birth (RR: 1.5, 95%CI: 1.0-2.2). There were no strong associations observed between social support questions and the various outcomes. CONCLUSIONS:Our results add some support to prior evidence that certain stressors may be associated with increase selected adverse birth outcomes risk. We did not find strong evidence that social support buffered the observed risks in our study.
| S-EPMC7446063 | biostudies-literature
Project description:Higher adult socioeconomic position (SEP) is associated with better birth outcomes. However, few studies incorporate life-course or intergenerational SEP, which may inform etiology and targeted prevention efforts. This study tested whether life-course social mobility from childhood was associated with lower risk of adverse birth outcomes.Data were from the Life-course Influences of Fetal Environments (LIFE) retrospective cohort study among black women, 2009-2011, in metropolitan Detroit, MI. This study (analyzed in 2014-2016) examined whether social mobility was associated with two primary birth outcomes: small for gestational age (SGA) and preterm birth (PTB). Childhood and adulthood SEP were measured by survey in adulthood, for two constructs, measured ordinally: educational attainment and perceived financial sufficiency (subjective income/wealth). Social mobility was calculated as the difference of adulthood minus childhood SEP.In covariate-adjusted Poisson regression models, 1-SD improved educational social mobility from childhood to adulthood was protective for SGA (adjusted risk ratio=0.76; 95% CI=0.64, 0.91); this association remained after adjusting for financial mobility. Upward financial social mobility from early childhood was marginally protective for SGA (adjusted risk ratio=0.85; 95% CI=0.72, 1.02), but became nonsignificant after controlling educational mobility. There were no overall associations of social mobility with PTB or low birth weight, although sensitivity analyses identified that improved financial mobility was associated with 16% marginally lower risk of spontaneous PTB and 28% marginally lower risk of low birth weight among upwardly mobile/stable women only.Improved life-course social mobility is associated with reduced risk for SGA and spontaneous PTB among black women.
| S-EPMC5167500 | biostudies-literature
Project description:BackgroundAlthough a number of studies have investigated correlations of maternal age with birth outcomes, an extensive assessment using age as a continuous variable is lacking. In the current study, we estimated age-specific risks of adverse birth outcomes in childbearing women.MethodNational population-based data containing maternal and neonatal information were derived from the Health Promotion Administration, Taiwan. A composite adverse birth outcome was defined as at least anyone of stillbirth, preterm birth, low birth weight, macrosomia, neonatal death, congenital anomaly, and small for gestational age (SGA). Singletons were further analyzed for outcomes of live birth in relation to each year of maternal age. A log-binomial model was used to adjust for possible confounders of maternal and neonatal factors.ResultsIn total, 2,123,751 births between 2001 and 2010 were utilized in the analysis. The risk of a composite adverse birth outcome was significantly higher at extreme maternal ages. In specific, risks of stillbirth, neonatal death, preterm birth, congenital anomaly, and low birth weight were higher at the extremes of maternal age. Furthermore, risk of macrosomia rose proportionally with an increasing maternal age. In contrast, risk of SGA declined proportionally with an increasing maternal age. The log-binomial model showed greater risks at the maternal ages of <26 and > 30 years for a composite adverse birth outcome.ConclusionsInfants born to teenagers and women at advanced age possess greater risks for stillbirth, preterm birth, neonatal death, congenital anomaly, and low birth weight. Pregnancies at advanced age carry an additional risk for macrosomia, while teenage pregnancies carry an additional risk for SGA. The data suggest that the optimal maternal ages to minimize adverse birth outcomes are 26?30 years.
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Project description:Micronutrient deficiencies and environmental exposures have been to known to adversely impact brain and nervous system functions in adults and children worldwide. However, few studies have examined the short and long-term impact of these risk factors on neurodevelopmental outcomes in children in low-income countries, where the effects are likely to be more pronounced due to limited resources for monitoring and insufficient regulations. Biological risk factors of relevance include micronutrient deficiencies such as zinc and exposure to heavy metals such as lead and mercury. Studies have suggested an association between neurodevelopmental impairment and micronutrient deficiency as well as exposure to a number of heavy metals and environmental toxins. Moreover, findings also suggest that risk factors for adverse developmental outcomes that are independently significant may have the potential for causing cumulative increases in adverse effects. In Sub-Saharan Africa, severe malaria is a leading risk factor for long-term neurocognitive impairment in children. Zinc deficiency or exposure to heavy metals could influence risk of severe malaria, modify the risk of neurocognitive impairment in children with severe malaria, or independently affect risk of neurocognitive impairment. Untargeted analyses for potential environmental exposures or metabolomic changes in children with cerebral malaria vs. without cognitive impairment or in children with higher vs. lower cognitive scores, could also identify new risk factors for neurodevelopmental impairment in Ugandan children with cerebral malaria.In our completed study in Kampala, we assessed neurologic and developmental impairment in children with cerebral malaria [CM] or severe malarial anemia [SMA], as compared to health community children from the same extended household as the children with CM or SMA. As an extension of this study, we are interested in determining levels of micronutrients such as zinc in the population, and in addition, determining exposure levels of heavy metals (lead, mercury, copper, manganese etc.) in samples collected from children with severe malaria and community controls. The primary hypotheses of this study is that nutrient deficiencies or exposure to heavy metals influence short and long term neurocognitive outcomes in healthy community children and in children with severe malaria, and that children with cerebral malaria have specific metabolomic changes that relate to long-term neurocognitive impairment. The specific aims of our study are:Aim 1: To determine levels of zinc, heavy metals, and biomarkers associated with inflammation in children presenting with different forms of severe malaria (SM) and in healthy community children (CC). The working hypothesis of this aim is that 1) children with SM will have lower zinc levels compared to CC; 2) children with SM will present with higher toxic metal exposure and higher levels of biomarkers associated with inflammation than CC.Aim 2: To investigate how micronutrient deficiency, toxic metal exposure and inflammatory biomarkers affect short and long term neurodevelopmental outcomes and growth in children with severe malaria and community children (CC).The working hypothesis of this aim is that the lower levels of zinc, and presence of toxic metals in high concentrations will independently contribute to worsening neurodevelopmental outcomes and worsening growth over time in children with severe malaria and in community children. An alternate hypothesis is that micronutrient deficiency, toxic metal exposure and inflammatory states may interact with each other and with severe malaria to produce greater neurodevelopmental impairment, i.e., that the contribution is not independent but interactive.Aim 3: To determine whether the CSF metabolome differs according to level of neurodevelopmental impairment in children with cerebral malaria. The working hypothesis of this aim is that neurodevelopmental impairment in children with cerebral malaria is associated with changes in the CSF metabolome.
2017-09-27 | ST000877 | MetabolomicsWorkbench