Increasing Preterm Delivery and Small for Gestational Age Trends in South Carolina during the COVID-19 Pandemic.

Preterm delivery (PTD) complications are a major cause of childhood morbidity and mortality. We aimed to assess trends in PTD and small for gestational age (SGA) and whether trends varied between race-ethnic groups in South Carolina (SC). We utilized 2015-2021 SC vital records linked to hospitalization and emergency department records. PTD was defined as clinically estimated gestation less than (<) 37 weeks (wks.) with subgroup analyses of PTD < 34 wks. and < 28 wks. SGA was defined as infants weighing below the 10th percentile for gestational age. This retrospective study included 338,532 (243,010 before the COVID-19 pandemic and 95,522 during the pandemic) live singleton births of gestational age ≥ 20 wks. born to 260,276 mothers in SC. Generalized estimating equations and a change-point during the first quarter of 2020 helped to assess trends. In unadjusted analyses, pre-pandemic PTD showed an increasing trend that continued during the pandemic (relative risk (RR) = 1.04, 95% CI: 1.02-1.06). PTD < 34 wks. rose during the pandemic (RR = 1.07, 95% CI: 1.02-1.12) with a significant change in the slope. Trends in SGA varied by race and ethnicity, increasing only in Hispanics (RR = 1.02, 95% CI: 1.00-1.04) before the pandemic. Our study reveals an increasing prevalence of PTD and a rise in PTD < 34 wks. during the pandemic, as well as an increasing prevalence of SGA in Hispanics during the study period.

The Association of Hypertensive Disorders of Pregnancy with Infant Mortality, Preterm Delivery, and Small for Gestational Age.

Gestational hypertension, preeclampsia, eclampsia, and chronic hypertension (CHTN) are associated with adverse infant outcomes and disproportionately affect minoritized race/ethnicity groups. We evaluated the relationships between hypertensive disorders of pregnancy (HDP) and/or CHTN with infant mortality, preterm delivery (PTD), and small for gestational age (SGA) in a statewide cohort with a diverse racial/ethnic population. All live, singleton deliveries in South Carolina (2004-2016) to mothers aged 12-49 were evaluated for adverse outcomes: infant mortality, PTD (20 to less than <37 weeks) and SGA (<10th birthweight-for-gestational-age percentile). Logistic regression models adjusted for sociodemographic, behavioral, and clinical characteristics. In 666,905 deliveries, mothers had superimposed preeclampsia (HDP + CHTN; 1.0%), HDP alone (8.0%), CHTN alone (1.8%), or no hypertension (89.1%). Infant mortality risk was significantly higher in deliveries to women with superimposed preeclampsia, HDP, and CHTN compared with no hypertension (relative risk [RR] = 1.79, 1.39, and 1.48, respectively). After accounting for differing risk by race/ethnicity, deliveries to women with HDP and/or CHTN were more likely to result in PTD (RRs ranged from 3.14 to 5.25) or SGA (RRs ranged from 1.67 to 3.64). As CHTN, HDP and superimposed preeclampsia confer higher risk of adverse outcomes, prevention efforts should involve encouraging and supporting mothers in mitigating modifiable cardiovascular risk factors.

Concurrent progestogen and cerclage to reduce preterm birth: a multicenter international retrospective cohort.

BACKGROUND: Both progestogens and cerclage are individually effective in preterm birth prevention in high risk pregnancies. However, national and international guidelines cite a lack of data available to comment on the potential benefit of concurrent progestogen therapy after cerclage has been placed. Studies to date have been small with mixed results regarding benefit of concurrent progestogen with cerclage leaving uncertainty regarding best clinical practice. OBJECTIVE: This study aimed to evaluate whether cerclage with progestogen therapy was superior to cerclage alone in the prevention of spontaneous preterm birth in singleton pregnancies. METHODS: This is an international retrospective cohort study of singleton pregnancies, without major anomaly or aneuploidy, and with cerclage placed at 10 different institutions in the United States and Colombia from June 2016 to June 2020. Exclusion criteria were lack of documentation regarding whether progestogen was prescribed, unavailable delivery outcome, and pregnancy termination (spontaneous or induced) before 16 weeks' gestation. The exposure of interest was progestogen use with cerclage placement, which included those who continued to use progestogen or who started progestogen after cerclage. The comparison group consisted of those without progestogen use after cerclage placement, which included those who had no progestogen use during the entire pregnancy or who initiated progestogen and then stopped it after cerclage placement. Progestogen type, cerclage indication, maternal baseline characteristics, and maternal/neonatal outcomes were collected. The primary outcome was spontaneous preterm birth at <37 weeks. The secondary outcomes were spontaneous preterm birth at <34 weeks, gestational age at delivery, and a composite neonatal outcome including ≥1 of the following: perinatal mortality, confirmed sepsis, grade III or IV intraventricular hemorrhage, retinopathy of prematurity, respiratory distress syndrome, and bronchopulmonary dysplasia. There were planned subgroup analyses by cerclage indication, progestogen type (vaginal progesterone vs 17-hydroxyprogesterone caproate), preterm birth history, and site. Continuous variables were compared in adjusted analyses with analysis of covariance, and categorical variables were compared with multivariable logistic regression, adjusting for potential confounders with adjusted odds ratio. A Cox regression survival curve was generated to compare latency to spontaneous delivery, censored after 37 weeks. RESULTS: During the study period, a total of 699 singletons met the inclusion criteria: 561 in the progestogen with cerclage group and 138 with cerclage alone. Baseline characteristics were similar, except the higher likelihood of previous spontaneous preterm birth in the progestogen group (61% vs 41%; P<.001). Within the progestogen group, 52% were on 17-hydroxyprogesterone caproate weekly, 44% on vaginal progesterone daily, and 3% on oral progesterone daily. Progestogen with cerclage was associated with a significantly lower frequency of spontaneous preterm birth <37 weeks (31% vs 39%; adjusted odds ratio, 0.59 [0.39-0.89]; P=.01) and <34 weeks (19% vs 27%; adjusted odds ratio, 0.55 [0.35-0.87]; P=.01), increased latency to spontaneous delivery (hazard ratio for spontaneous preterm birth <37 weeks, 0.66 [0.49-0.90]; P=.009), and lower frequency of perinatal death (7% vs 16%; adjusted odds ratio, 0.37 [0.20-0.67]; P=.001). In planned subgroup analyses, association with reduced odds of preterm birth <37 weeks persisted in those on vaginal progesterone, those without a previous preterm birth, those with ultrasound- or examination-indicated cerclage, those who started progestogen therapy before cerclage, and in sites restricted to the United States. CONCLUSION: Use of progestogen with cerclage was associated with reduced rates of spontaneous preterm birth and early spontaneous preterm birth compared with cerclage alone. Although this study was not sufficiently powered for subgroup analysis, the strength of evidence for benefit appeared greatest for those with ultrasound- or examination-indicated cerclage, and with vaginal progesterone.

Hypertensive Disorders of Pregnancy and Pre-Pregnancy Hypertension with Subsequent Incident Venous Thromboembolic Events.

Hypertensive disorders of pregnancy (HDP) and pre-pregnancy hypertension contribute to maternal morbidity and mortality. We examined the association of HDP and pre-pregnancy hypertension with subsequent venous thromboembolic (VTE) events. The retrospective cohort study included 444,859 women with ≥1 live, singleton birth in South Carolina (2004-2016). Hospital and emergency department visit and death certificate data defined incident VTE, HDP, and pre-pregnancy hypertension. Birth certificate data also defined the exposures. Adjusted Cox proportional hazards methods modeled VTE events risk. Of the cohort, 2.6% of women had pre-pregnancy hypertension, 5.8% had HDP, 2.8% had both pre-pregnancy hypertension and HDP (both conditions), and 88.8% had neither condition. The risk of incident VTE events within one year of delivery was higher in women with HDP (hazard ratio [HR] = 1.62, 95% confidence interval [CI]: 1.15-2.29) and both conditions (HR = 2.32, 95% CI: 1.60-3.35) compared to those with neither condition as was the risk within five years for women with HDP (HR = 1.35, 95% CI: 1.13-1.60) and for women with both conditions (HR = 1.82, 95% CI: 1.50-2.20). One- and five-year risks did not differ in women with pre-pregnancy hypertension compared to women with neither condition. Compared to non-Hispanic White (NHW) women with neither condition, the incident VTE event risk was elevated within five years of delivery for NHW (HR = 1.29, 95% CI: 1.02-1.63; HR = 1.59, 95% CI: 1.16-2.17) and non-Hispanic Black (NHB; HR = 1.51, 95% CI: 1.16-2.96; HR = 2.08, 95% CI: 1.62-2.66) women with HDP and with both conditions, respectively, and for NHB women with pre-pregnancy hypertension (HR = 1.50, 95% CI: 1.09-2.07). VTE event risk was highest in women with HDP, and the event rates were higher in NHB women than in NHW women in the same exposure group.

Timing of Delivery for Twins With Growth Discordance and Growth Restriction: An Individual Participant Data Meta-analysis.

OBJECTIVE: First, to evaluate the risks of stillbirth and neonatal death by gestational age in twin pregnancies with different levels of growth discordance and in relation to small for gestational age (SGA), and on this basis to establish optimal gestational ages for delivery. Second, to compare these optimal gestational ages with previously established optimal delivery timing for twin pregnancies not complicated by fetal growth restriction, which, in a previous individual patient meta-analysis, was calculated at 37 0/7 weeks of gestation for dichorionic pregnancies and 36 0/7 weeks for monochorionic pregnancies. DATA SOURCES: A search of MEDLINE, EMBASE, ClinicalTrials.gov, and Ovid between 2015 and 2018 was performed of cohort studies reporting risks of stillbirth and neonatal death in twin pregnancies from 32 to 41 weeks of gestation. Studies from a previous meta-analysis using a similar search strategy (from inception to 2015) were combined. Women with monoamniotic twin pregnancies were excluded. METHODS OF STUDY SELECTION: Overall, of 57 eligible studies, 20 cohort studies that contributed original data reporting on 7,474 dichorionic and 2,281 monochorionic twin pairs. TABULATION, INTEGRATION, AND RESULTS: We performed an individual participant data meta-analysis to calculate the risk of perinatal death (risk difference between prospective stillbirth and neonatal death) per gestational week. Analyses were stratified by chorionicity, levels of growth discordance, and presence of SGA in one or both twins. For both dichorionic and monochorionic twins, the absolute risks of stillbirth and neonatal death were higher when one or both twins were SGA and increased with greater levels of growth discordance. Regardless of level of growth discordance and birth weight, perinatal risk balanced between 36 0/7-6/7 and 37 0/7-6/7 weeks of gestation in both dichorionic and monochorionic twin pregnancies, with likely higher risk of stillbirth than neonatal death from 37 0/7-6/7 weeks onward. CONCLUSION: Growth discordance or SGA is associated with higher absolute risks of stillbirth and neonatal death. However, balancing these two risks, we did not find evidence that the optimal timing of delivery is changed by the presence of growth disorders alone. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42018090866.

Hypertensive Disorders of Pregnancy With and Without Prepregnancy Hypertension Are Associated With Incident Maternal Kidney Disease Subsequent to Delivery.

BACKGROUND: Maternal morbidity and mortality are related to prepregnancy hypertensive disease and hypertensive disorders of pregnancy (HDP) including preeclampsia (41.1% of HDP), eclampsia (1.3% of HDP), and gestational hypertension (39.9% of HDP). Less information is available on the risk of maternal kidney disease and potential racial/ethnic differences following a hypertensive condition during pregnancy. Our objective was to examine the relationships between HDP and prepregnancy hypertension with maternal incident kidney disease subsequent to delivery (up to 3, 5, and 14 years) with consideration of racial/ethnic differences. METHODS: In a retrospective cohort study, 391 838 women 12 to 49 years of age had a live birth in South Carolina between 2004 and 2016; 35.1% non-Hispanic Black (NHB) and 64.9% non-Hispanic White (NHW). Hospitalization, emergency department, and birth certificate data defined prepregnancy hypertension and HDP. Hospitalization and death certificate data identified incident kidney disease. RESULTS: 317 006 (80.8%) women experienced neither condition, 1473 (0.4%) had prepregnancy hypertension, 64 050 (16.3%) had HDP, and 9662 (2.5%) had both conditions (prepregnancy hypertension with superimposed HDP, ie, preeclampsia). Five years after delivery, incident kidney disease risk was increased for NHB and NHW women with HDP (NHB: hazard ratio, 2.30 [95% CI, 1.94-2.73]; NHW: hazard ratio, 1.97 [95% CI, 1.64-2.37]) and with both conditions (NHB: hazard ratio, 3.88 [95% CI, 3.05-4.93]; NHW: hazard ratio, 1.86 [95% CI, 1.20-2.87]) compared with counterparts with neither condition after adjustment (P value for race/ethnicity interaction=0.003). CONCLUSIONS: Increased kidney disease risk 5 years after delivery was observed for women with HDP and with both compared with neither condition, with associated risk higher in NHB than NHW women.

Impact of the Salud Mesoamerica Initiative on delivery care choices in Guatemala, Honduras, and Nicaragua.

BACKGROUND: The Salud Mesoamérica Initiative (SMI) is a public-private collaboration aimed to improve maternal and child health conditions in the poorest populations of Mesoamerica through a results-based aid mechanism. We assess the impact of SMI on the staffing and availability of equipment and supplies for delivery care, the proportion of institutional deliveries, and the proportion of women who choose a facility other than the one closest to their locality of residence for delivery. METHODS: We used a quasi-experimental design, including baseline and follow-up measurements between 2013 and 2018 in intervention and comparison areas of Guatemala, Nicaragua, and Honduras. We collected information on 8754 births linked to the health facility closest to the mother's locality of residence and the facility where the delivery took place (if attended in a health facility). We fit difference-in-difference models, adjusting for women's characteristics (age, parity, education), household characteristics, exposure to health promotion interventions, health facility level, and country. RESULTS: Equipment, inputs, and staffing of facilities improved after the Initiative in both intervention and comparison areas. After adjustment for covariates, institutional delivery increased between baseline and follow-up by 3.1 percentage points (ß = 0.031, 95% CI -0.03, 0.09) more in intervention areas than in comparison areas. The proportion of women in intervention areas who chose a facility other than their closest one to attend the delivery decreased between baseline and follow-up by 13 percentage points (ß = - 0.130, 95% CI -0.23, - 0.03) more than in the comparison group. CONCLUSIONS: Results indicate that women in intervention areas of SMI are more likely to go to their closest facility to attend delivery after the Initiative has improved facilities' capacity, suggesting that results-based aid initiatives targeting poor populations, like SMI, can increase the use of facilities closest to the place of residence for delivery care services. This should be considered in the design of interventions after the COVID-19 pandemic may have changed health and social conditions.

Incident Heart Failure Within the First and Fifth Year after Delivery Among Women With Hypertensive Disorders of Pregnancy and Prepregnancy Hypertension in a Diverse Population.

Background Hypertensive disorders of pregnancy (HDP) and pre-pregnancy hypertension are associated with increased morbidity and mortality for the mother. Our aim was to investigate the relationships between HDP and pre-pregnancy hypertension with maternal heart failure (HF) within 1 and 5 years of delivery and to examine racial/ethnic differences. Methods and Results We conducted a retrospective cohort study in South Carolina (2004-2016) involving 425 649 women aged 12 to 49 years (58.9% non-Hispanic White [NHW], 31.5% non-Hispanic Black [NHB], 9.6% Hispanic) with a live, singleton birth. Incident HF was defined by hospital/emergency department visit and death certificate data. Pre-pregnancy hypertension and HDP (preeclampsia, eclampsia, or gestational hypertension) were based on hospitalization/emergency department visit and birth certificate data (i.e., gestational hypertension for HDP). The 425 649 women had pre-pregnancy hypertension without superimposed HDP (pre-pregnancy hypertension alone; 0.4%), HDP alone (15.7%), pre-pregnancy hypertension with superimposed HDP (both conditions; 2.2%), or neither condition in any pregnancy (81.7%). Incident HF event rates per 1000 person-years were higher in NHB than NHW women with HDP (HDP: 2.28 versus 0.96; both conditions: 4.30 versus 1.22, respectively). After adjustment, compared with women with neither condition, incident HF risk within 5 years of delivery was increased for women with pre-pregnancy hypertension (HR,2.55, 95% CI: 1.31-4.95), HDP (HR,4.20, 95% CI: 3.66-4.81), and both conditions (HR,5.25, 95% CI: 4.24-6.50). Conclusions Women with HDP and pre-pregnancy hypertension were at higher HF risk (highest for superimposed preeclampsia) within 5 years of delivery. NHB women with HDP had higher HF risk than NHW women, regardless of pre-pregnancy hypertension.

Genetic markers for preeclampsia in Peruvian women.

BACKGROUND: Preeclampsia is a multiorgan disorder associated with maternal and perinatal morbi-mortality. In Peru, incidence is 10% and accounts for 22% of maternal deaths. Genome and genetic epidemiological studies have found an association between preeclampsia and genetic polymorphisms. OBJECTIVE: To determine the association of the vascular endothelial growth factor (VEGF) +936 C/T and +405 G/C, interleukine-6 (IL-6) -174 G/C, IL-1ß-511 C/T, Apo A-1-75 G/A, Apo B-100 2488 C/T (Xbal) polymorphisms with preeclampsia in pregnant Peruvian women. METHODS: Were included preeclamptic and healthy (control) pregnant women. Maternal blood samples were subjected to DNA extraction, and molecular genetic analysis was conducted using the PCR-RFLP technique and following a specific protocol for each gene. Allele and genotypic frequencies in the cases and controls were compared. RESULTS: No association was found between the VEGF+936C/T and VEGF+405 polymorphisms and preeclampsia. The frequencies of the GG genotypes and the G allele of the -174 G/C polymorphism in the IL6 gene in preeclamptic and controls showed significant differences, with higher frequencies in cases. For the -511 C/T polymorphism of the IL-1ß gene, no significant differences were found in the frequencies of TT genotypes compared with CT+CC. The genotypes and alleles of the Apo-A1-75 G/A and Apo-B100 Xbal variants showed no significant differences between cases and controls. CONCLUSION: No association was found between the studied genetic markers and preeclampsia. However, in the -174G/C polymorphism of the IL-6 gene, significant differences were found mainly in the GG genotype and G allele.

Genetic markers for preeclampsia in Peruvian women / Marcadores genéticos de preeclampsia en mujeres peruanas

Abstract Background: Preeclampsia is a multiorgan disorder associated with maternal and perinatal morbi-mortality. In Peru, incidence is 10% and accounts for 22% of maternal deaths. Genome and genetic epidemiological studies have found an association between preeclampsia and genetic polymorphisms. Objective: To determine the association of the vascular endothelial growth factor (VEGF) +936 C/T and +405 G/C, interleukine-6 (IL-6) -174 G/C, IL-1β-511 C/T, Apo A-1-75 G/A, Apo B-100 2488 C/T (Xbal) polymorphisms with preeclampsia in pregnant Peruvian women. Methods: Were included preeclamptic and healthy (control) pregnant women. Maternal blood samples were subjected to DNA extraction, and molecular genetic analysis was conducted using the PCR-RFLP technique and following a specific protocol for each gene. Allele and genotypic frequencies in the cases and controls were compared. Results: No association was found between the VEGF+936C/T and VEGF+405 polymorphisms and preeclampsia. The frequencies of the GG genotypes and the G allele of the -174 G/C polymorphism in the IL6 gene in preeclamptic and controls showed significant differences, with higher frequencies in cases. For the -511 C/T polymorphism of the IL-1β gene, no significant differences were found in the frequencies of TT genotypes compared with CT+CC. The genotypes and alleles of the Apo-A1-75 G/A and Apo-B100 Xbal variants showed no significant differences between cases and controls. Conclusion: No association was found between the studied genetic markers and preeclampsia. However, in the -174G/C polymorphism of the IL-6 gene, significant differences were found mainly in the GG genotype and G allele.

Resumen Antecedentes: La preeclampsia es un trastorno multiorgánico asociado con la morbi-mortalidad materna y perinatal. En el Perú, su incidencia es del 10% y causa el 22% de las muertes maternas. Se encontró una asociación entre la preeclampsia y ciertos polimorfismos. Objetivo: Determinar asociación entre los polimorfismos genéticos del factor de crecimiento endotelial vascular (VEGF) +936 C/T y +405 G/C, interleucina-6 (IL-6) -174G/C, IL-1β -511 C/T, Apo A-1 -75 G/A, Apo B-100 2488 C/T (Xbal), y preeclampsia en gestantes peruanas. Métodos: Se incluyeron gestantes preeclámpticas y sanas (controles). Las muestras de sangre fueron procesadas para extracción del ADN, y el análisis se realizó con la técnica PCR-RFLP con protocolos específicos para cada gen y confirmación con secuenciamiento Sanger. Se compararon las frecuencias alélicas y genotípicas en los casos (preeclampsia) y los controles. Resultados: No se halló asociación entre los polimorfismos VEGF+936-C/T y VEGF+405 y la preeclampsia. Las frecuencias de los genotipos GG y el alelo G del polimorfismo -174-G/C en el gen IL6 en preeclámpticas y controles, mostraron diferencias significativas, con frecuencias más altas en los casos. Para el polimorfismo -511-C/T del gen IL-1β, no se encontraron diferencias significativas en las frecuencias de genotipos TT comparados con CT+CC. Los genotipos y alelos de las variantes Apo-A1-75-G/A y Apo-B100 Xbal no mostraron diferencias significativas entre los grupos Conclusión: No se encontró asociación entre los marcadores genéticos estudiados y la preeclampsia. Sin embargo, el polimorfismo -174-G/C en el gen IL6 mostró diferencias significativas principalmente en el genotipo GG y el alelo G.

Maternal Coronary Heart Disease, Stroke, and Mortality Within 1, 3, and 5 Years of Delivery Among Women With Hypertensive Disorders of Pregnancy and Pre-Pregnancy Hypertension.

Background Pre-pregnancy hypertension and hypertensive disorders of pregnancy (HDP; preeclampsia, eclampsia, gestational hypertension) are major health risks for maternal morbidity and mortality. However, it is unknown if racial/ethnic differences exist. We aimed to determine the impact of HDP and pre-pregnancy hypertension on maternal coronary heart disease, stroke, and mortality risk ≤1, 3, and 5 years post-delivery and by race/ethnicity ≤5 years. Methods and Results This retrospective cohort study included women aged 12 to 49 years with a live, singleton birth between 2004 to 2016 (n=254 491 non-Hispanic White; n=137 784 non-Hispanic Black; n=41 155 Hispanic). Birth and death certificates and International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification (ICD-9-CM and ICD-10-CM) diagnosis codes in hospitalization/emergency department visit data defined HDP, pre-pregnancy hypertension, incident coronary heart disease and stroke, and all-cause mortality. During at least 1 pregnancy of the 433 430 women, 2.3% had pre-pregnancy hypertension with superimposed HDP, 15.7% had no pre-pregnancy hypertension with HDP, and 0.4% had pre-pregnancy hypertension without superimposed HDP, whereas 81.6% had neither condition. Maternal deaths from coronary heart disease, stroke, and all causes totaled 2136. Within 5 years of delivery, pre-pregnancy hypertension, and HDP were associated with all-cause mortality (hazard ratio [HR], 2.21; 95% CI, 1.61-3.03), incident coronary heart disease (HR, 3.79; 95% CI, 3.09-4.65), and incident stroke (HR, 3.10; 95% CI, 2.09-4.60). HDP alone was related to all outcomes. Race/ethnic differences were observed for non-Hispanic Black and non-Hispanic White women, respectively, in the associations of pre-pregnancy hypertension and HDP with all-cause mortality within 5 years of delivery (HR, 2.34 [95% CI, 1.58-3.47]; HR, 2.11 [95% CI, 1.23-3.65]; P interaction=0.001). Conclusions Maternal cardiovascular outcomes including mortality were increased ≤5 years post-delivery in HDP, pre-pregnancy hypertension, or pre-pregnancy hypertension with superimposed HDP. The race/ethnic interaction for all-cause mortality ≤5 years of delivery warrants further research.

Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia? / ¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia?

Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

¿Responde la Resolución 8430 de 1993 a las necesidades actuales de la ética de la investigación en salud con seres humanos en Colombia? / Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia?

Resumen La verificación del cumplimiento de los principios éticos en la investigación en salud legitima su ejercicio ante la sociedad y posibilita la resolución de dilemas éticos frente a nuevos intereses y métodos de investigación. En Colombia, la Resolución 8430 de 1993 es una de las principales pautas éticas que regulan la investigación en salud. Dado que no ha sido revisada ni actualizada desde su adopción, se hace necesario valorar su vigencia y suficiencia para abordar los potenciales dilemas éticos que se plantean actualmente en la investigación en salud en el país. En este contexto, se detallan algunos vacíos y contradicciones, así como aspectos que requieren de una revisión profunda, a partir de una concepción amplia de las áreas y los métodos de investigación en salud. Tras discutir las principales falencias e imprecisiones, se proponen alternativas para que la Resolución responda a las necesidades actuales del país frente a la ética en investigación en salud con seres humanos.

Abstract Verifying the compliance with the ethical principles of health research legitimizes its exercise in the eyes of the society and allows for the resolution of ethical dilemmas that emerge from new research interests and methods. Resolution 8430 of 1993 is one of the main ethical guidelines governing health research on human beings in Colombia. Considering that the resolution has not been revised or updated since its promulgation it becomes necessary to evaluate its current validity and adequacy to address the potential ethical dilemmas in the existing country's health research. Some gaps, contradictions, and aspects that require a deep review are detailed in this paper from a wide conception of health research areas and methods. After discussing the main weaknesses and inaccuracies, some alternatives are proposed to adjust the resolution to the present needs in health research with human beings.

Fetal growth patterns in pregnancy-associated hypertensive disorders: NICHD Fetal Growth Studies.

BACKGROUND: Fetal growth patterns in pregnancy-associated hypertensive disorders is poorly understood because prospective longitudinal data are lacking. OBJECTIVE: The objective of the study was to compare longitudinal fetal growth trajectories between normotensive women and those with pregnancy-associated hypertensive disorders. STUDY DESIGN: This is a study based on data from a prospective longitudinal cohort study of fetal growth performed at 12 US sites (2009-2013). Project gestational age was confirmed by ultrasound between 8 weeks 0 days and 13 weels 6 days, and up to 6 ultrasounds were performed across gestation. Hypertensive disorders were diagnosed based on 2002 American College of Obstetricians and Gynecologists guidelines and grouped hierarchically as severe preeclampsia (including eclampsia or HELLP [hemolysis, elevated liver enzymes, and low platelet count] syndrome), mild preeclampsia, severe gestational hypertension, mild gestational hypertension, or unspecified hypertension. Women without any hypertensive disorder constituted the normotensive group. Growth curves for estimated fetal weight and individual biometric parameters including biparietal diameter, head circumference, abdominal circumference, and femur and humerus length were calculated for each group using linear mixed models with cubic splines. Global and weekly pairwise comparisons were performed between women with a hypertensive disorder compared with normotensive women to analyze differences while adjusting for confounding variables. Delivery gestational age and birthweights were compared among groups. RESULTS: Of 2462 women analyzed, 2296 (93.3%) were normotensive, 63 (2.6%) had mild gestational hypertension, 54 (2.2%) mild preeclampsia, 32 (1.3%) severe preeclampsia, and 17 (0.7%) unspecified hypertension. Compared with normotensive women, those with severe preeclampsia had estimated fetal weights that were reduced between 22 and 38 weeks (all weekly pairwise values of P < .008). Women with severe preeclampsia compared with those without hypertension also had significantly smaller fetal abdominal circumference between 23-31 and 33-37 weeks' gestation (weekly pairwise values of P < .04). Scattered weekly growth differences were noted on other biometric parameters between these 2 groups. The consistent differences in estimated fetal weight and abdominal circumference were not observed between women with other hypertensive disorders and those who were normotensive. Women with severe preeclampsia delivered significantly earlier (mean gestational age 35.9 ± 3.2 weeks) than the other groups (global P < .0001). Birthweights in the severe preeclampsia group were also significantly lower (mean -949.5 g [95% confidence interval, -1117.7 to -781.2 g]; P < .0001) than in the normotensive group. CONCLUSION: Among women with pregnancy-associated hypertensive disorders, only those destined to develop severe preeclampsia demonstrated a significant and consistent difference in fetal growth (ie, smaller estimated fetal weight and abdominal circumference) when compared with normotensive women.

Impact evaluation of camera enforcement for traffic violations in Cali, Colombia, 2008-2014.

INTRODUCTION: Cameras for detecting traffic violations have been used as a measure to improve road safety in different countries around the world. In Cali, Colombia, fixed cameras were installed in March 2012 on a number of roads and intersections. All camera devices are capable of detecting simultaneously the following traffic violations: driving over the speed limit, running a red light or stop sign, violation of the traffic ban schedule, and blocking the pedestrian crosswalk. OBJECTIVE: To evaluate the impact of camera enforcement of traffic violations in Cali, Colombia. METHODS: A quasi-experimental difference-in-differences study with before and after measurements and a comparison group was conducted. We observed 38 intervention areas and 50 comparison areas (250 m radius), during 42 months before and 34 months after the installation of cameras. Effects were estimated with mixed negative binomial regression models. RESULTS: In intervention areas, after 12 months, there was a reduction of 19.2% of all crashes and a 24.7% reduction of injury and fatal crashes. In comparison areas, this reduction was 15.0% for all crashes and 20.1% for injury and fatal crashes. After adjusted comparisons, intervention sites outperformed comparison sites with an additional yearly reduction of 5.3% (p = 0.045) for all crashes. CONCLUSIONS: The use of cameras for detecting traffic violations seems to have a positive effect on the reduction of crashes in intervention areas. A beneficial spillover effect was found as well in comparison areas; but more evaluations are needed.

Massive Urinary Protein Excretion Associated with Greater Neonatal Risk in Preeclampsia.

Objective The objective of this study was to compare clinical outcomes of preeclamptic pregnancies according to the proteinuria level. Study Design Secondary analysis of a multicenter prospective cohort study of women with preeclampsia (PE) symptomatology. Nonproteinuria, mild-proteinuria, and massive-proteinuria PEs were defined as: < 165 mg in 12 hours or < 300 mg in 24 hours, 165 mg to 2.69 g in 12 hours or 300 mg to 4.99 g in 24 hours, and ≥ 2.7 g in 12 hours or ≥ 5.0 g in 24 hours, respectively. Individual and composite maternal, fetal, and neonatal outcomes were compared among the PE groups. Results Of the 406 analyzed pregnancies, 36 (8.8%) had massive-proteinuria PE, 268 (66.0%) mild-proteinuria PE, and 102 (25.1%) nonproteinuria PE. Compared with the other groups, massive-proteinuria PE women had significantly higher blood pressures (p < 0.001), epigastric pain (p = 0.007), and uric acid serum levels (p < 0.001) prior to delivery. Composite maternal morbidity was similar across the groups. Delivery < 340/7 weeks occurred in 80.6, 49.3, and 22.5% of massive-proteinuria, mild-proteinuria, and nonproteinuria PE groups, respectively (p < 0.0001). Composite adverse neonatal outcomes were significantly higher in the massive-proteinuria PE compared with the other groups (p = 0.001). Conclusion While potentially not important diagnostically, massive proteinuria is associated with more severe clinical manifestations of PE prompting earlier delivery.

The burden of severe maternal morbidity in contemporaneous Obstetrics / El lastre de la morbilidad materna severa en la Obstetricia contemporánea

Maternal health is deteriorating across the world due to multiple factors including increasing rates of obesity, chronic medical conditions such as chronic hypertension, type II diabetes, and cardiovascular disease, as well as advanced maternal age by the time of conception. These factors summed to the increasing cesarean delivery rate, lack of standardization of clinical practices, and inappropriate care during obstetrical urgencies are all major contributors to the rising rates of major obstetrical complications and maternal death. In recent years, national and international health care organizations have proposed new definitions of major maternal morbidity. The World Health Organization (WHO) defines "near maternal miss" (NMM) as the series of events leading from good health to a life-threatening complication associated with organ dysfunction or failure. Conversely, the Centers for Disease Control and Prevention (CDC) in United States classify "severe maternal morbidity" (SMM) if a pregnancy is complicated by one or more of twenty five ICD-9 clinical complications/procedures associated with a high maternal mortality risk. Although, each organization uses a different approach, existing data indicate that diagnostic criteria used for the CDC or the WHO accurately predicts pregnancies complicated with a "true" life-threatening maternal complication. These definitions are essential to better understand the burden of the disease. Each hospital providing maternal health care should adopt the definition that better fits its own health care system and is urged to incorporate initiatives that can reduce preventable major maternal complications. A fundamental step to address this issue is the establishment of a standardized review or audit process conducted by a multidisciplinary team that assesses systematically cases of severe maternal morbidity and mortality, evaluates deficiencies of health care at the provider, institution, and system levels, and adopts programs to improve quality of care. Maternal warning systems, composed by a set of abnormal physiological parameters that alert the provider about the deterioration of the patient's condition and prompt immediate bedside assessment, have shown to be effective in reducing maternal morbidity and mortality. Of importance, it has been recently demonstrated that linking these warning systems to standardized evidence-based clinical guidelines that address the most common obstetrical clinical pathways provides further benefits to the patient's care and improves outcomes. Despite the advances in the early detection and management of major maternal morbidity, there is a concise need of further research to standardize definitions at regional, national and international levels, validate the effectiveness of early warning systems in different clinical settings, improve long-term outcomes, and incorporate other preventive measures initiated even prior to conception to further decline the rates of serious maternal complications and death.

La salud materna se está deteriorando en el mundo debido a múltiples factores, entre los cuales se encuentran el incremento de las tasas de obesidad, las enfermedades crónicas como la hipertensión crónica, la diabetes mellitus tipo II y la enfermedad cardiovascular, así como la edad materna avanzada al momento de la concepción. Estos factores sumados a la mayor tasa de cesáreas, la falta de estandarización de la práctica clínica y la atención inapropiada de las urgencias obstétricas son las que contribuyen tremendamente al incremento de complicaciones obstétricas graves y muerte materna. En años recientes, las organizaciones de salud nacionales e internacionales han propuesto nuevas definiciones de la morbilidad materna severa. La Organización Mundial de la Salud (OMS) define 'morbilidad materna extrema' (MME) como una serie de ocurrencias que parten de la buena salud y se complican al punto de poner en riesgo de muerte por disfunción o falla orgánica. Al contrario, los Centros para el Control y Prevención de las Enfermedades (CDC) en los Estados Unidos clasifican como 'morbilidad materna grave' (MMS) si un embarazo se complica con una o más de las veinticinco complicaciones/procedimientos clínicos de la Clasificación Internacional de Enfermedades (ICD-9) asociados con un riesgo alto de mortalidad materna. Aunque cada organización emplea una aproximación diferente, la información existente indica que los criterios diagnósticos utilizados por el CDC o la OMS predicen con mucha precisión aquellas gestaciones complicadas con una 'verdadera' complicación materna que amenaza su vida. Estas definiciones son esenciales para comprender mejor la dimensión de la enfermedad. Cada hospital que provee atención de la salud materna deberá adoptar la definición que mejor se adapte a su propio sistema de salud y es urgido a incorporar iniciativas que puedan reducir las complicaciones maternas severas. Un paso fundamental para resolver este aspecto es establecer una revisión estandarizada o proceso de auditoría conducido por un equipo multidisciplinario que analice sistemáticamente los casos de morbilidad y mortalidad materna grave. Este equipo está encargado de evaluar las deficiencias de los proveedores de salud, de la institución y de los niveles del sistema. Además, tiene la obligación de implementar programas que mejoren la calidad de la atención. Los sistemas de alarma materna, compuestos por un grupo de parámetros fisiológicos anormales, han sido creados con el objetivo de alertar al proveedor sobre el deterioro de las condiciones de la paciente, exigiendo una pronta evaluación, reduciendo así la morbimortalidad materna. Recientemente se ha demostrado que al unir estos sistemas de alarma a las guías clínicas estandarizadas y basadas en la evidencia que están dirigidas a las complicaciones clínicas obstétricas más comunes permite mayores beneficios para el manejo de la paciente y mejora los resultados clínicos. A pesar de los avances en la detección y manejo temprano de la morbilidad materna severa, existe una necesidad de mayor investigación para estandarizar las definiciones a nivel regional, nacional e internacional y validar la efectividad de los sistemas de alarma temprana en diferentes escenarios clínicos. Además, es necesario implementar nuevas estrategias para mejorar los resultados maternos a largo plazo e incorporar otras medidas preventivas iniciadas aún antes de la concepción, de manera que se logre disminuir aún más las tasas de complicaciones graves y la muerte materna.

[Toward a national plan to control health effects of mercury in Colombia]. / Hacia un plan nacional para el control de los efectos del mercurio en la salud en Colombia.

INTRODUCTION: The problem of mercury effects on humans and the environment is global, and it has different impacts on health. It is necessary, therefore, to address this issue from a broad overview to identify populations at risk of exposure, health effects, the production processes involved and the actions aimed at reducing exposure and mitigating the impact. OBJECTIVE: To design a conceptual and operational framework to develop strategies for prevention, control and mitigation of mercury effects on health and on the environment in Colombia. MATERIALS AND METHODS: We conducted a two-phase study: a literature review following the Cochrane methodology and forums with national and international experts using a comprehensive planning methodology to identify priority actions and establish a national research agenda. RESULTS: The results of the review were structured into four components: mercury effects on health, legal framework in Colombia, emission inventory for the country and health plans and programs. We made recommendations for the design of an intervention plan considering five lines of action: technologies for exposure management, institutional strengthening for exposure prevention and control, strategies for strengthening diagnosis and care, health education on mercury risks, and knowledge generation. CONCLUSION: We detected information gaps, technical weaknesses, and the need of administrative and other resources in this field in Colombia. We proposed priority actions to reduce the economic, social and health impact from exposure to mercury.

Hacia un plan nacional para el control de los efectos del mercurio en la salud en Colombia / Toward a national plan to control health effects of mercury in Colombia

Introducción. La problemática del uso del mercurio es global y afecta tanto a los humanos como al ambiente. Los efectos del mercurio en la salud son diversos, por eso es necesario abordar el problema desde una perspectiva amplia, identificando las poblaciones en riesgo de exposición, sus efectos en la salud, los procesos productivos involucrados y las acciones para disminuir la exposición y mitigar el impacto. Objetivo. Diseñar un marco conceptual y operativo para desarrollar estrategias de prevención, control y mitigación de los efectos del mercurio sobre la salud y el ambiente en Colombia. Materiales y métodos. Se hizo un estudio en dos fases: una revisión de la literatura científica siguiendo la metodología Cochrane, y foros con expertos nacionales e internacionales orientados a la planificación integral para identificar las acciones prioritarias y construir la agenda de investigación nacional . Resultados. Los resultados de la revisión se estructuraron en cuatro componentes: efectos del mercurio en la salud, marco legal en Colombia, inventario de emisiones en el país, y planes y programas existentes en el sector de la salud. Se presentaron recomendaciones para diseñar un plan de intervenciones considerando cinco líneas de acción: gestión tecnológica para la prevención de la exposición, fortalecimiento institucional para la prevención y el control de la exposición, fortalecimiento de estrategias de diagnóstico y atención, educación en salud sobre los riesgos del mercurio y generación de conocimiento . Conclusiones. Se visibilizaron vacíos de información, así como debilidades técnicas, administrativas y necesidad de recursos en Colombia, y se propusieron acciones prioritarias para disminuir el impacto económico, social y en salud de la exposición al mercurio.

Introduction: The problem of mercury effects on humans and the environment is global, and it has different impacts on health. It is necessary, therefore, to address this issue from a broad overview to identify populations at risk of exposure, health effects, the production processes involved and the actions aimed at reducing exposure and mitigating the impact. Objective: To design a conceptual and operational framework to develop strategies for prevention, control and mitigation of mercury effects on health and on the environment in Colombia. Materials and methods: We conducted a two-phase study: a literature review following the Cochrane methodology and forums with national and international experts using a comprehensive planning methodology to identify priority actions and establish a national research agenda. Results: The results of the review were structured into four components: mercury effects on health, legal framework in Colombia, emission inventory for the country and health plans and programs. We made recommendations for the design of an intervention plan considering five lines of action: technologies for exposure management, institutional strengthening for exposure prevention and control, strategies for strengthening diagnosis and care, health education on mercury risks, and knowledge generation. Conclusion: We detected information gaps, technical weaknesses, and the need of administrative and other resources in this field in Colombia. We proposed priority actions to reduce the economic, social and health impact from exposure to mercury.