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BACKGROUND: Recognizing premature newborns and small-for-gestational-age (SGA) is essential for providing care and supporting public policies. This systematic review aims to identify the influence of the last menstrual period (LMP) compared to ultrasonography (USG) before 24 weeks of gestation references on prematurity and SGA proportions at birth. METHODS: Systematic review with meta-analysis followed the recommendations of the PRISMA Statement. PubMed, BVS, LILACS, Scopus-Elsevier, Embase-Elsevier, and Web-of-Science were searched (10-30-2022). The research question was: (P) newborns, (E) USG for estimating GA, (C) LMP for estimating GA, and (O) prematurity and SGA rates for both methods. Independent reviewers screened the articles and extracted the absolute number of preterm and SGA infants, reference standards, design, countries, and bias. Prematurity was birth before 37 weeks of gestation, and SGA was the birth weight below the p10 on the growth curve. The quality of the studies was assessed using the New-Castle-Ottawa Scale. The difference between proportions estimated the size effect in a meta-analysis of prevalence. RESULTS: Among the 642 articles, 20 were included for data extraction and synthesis. The prematurity proportions ranged from 1.8 to 33.6% by USG and varied from 3.4 to 16.5% by the LMP. The pooled risk difference of prematurity proportions revealed an overestimation of the preterm birth of 2% in favor of LMP, with low certainty: 0.02 (95%CI: 0.01 to 0.03); I2 97%). Subgroup analysis of USG biometry (eight articles) showed homogeneity for a null risk difference between prematurity proportions when crown-rump length was the reference: 0.00 (95%CI: -0.001 to 0.000; I2: 0%); for biparietal diameter, risk difference was 0.00 (95%CI: -0.001 to 0.000; I2: 41%). Only one report showed the SGA proportions of 32% by the USG and 38% by the LMP. CONCLUSIONS: LMP-based GA, compared to a USG reference, has little or no effect on prematurity proportions considering the high heterogeneity among studies. Few data (one study) remained unclear the influence of such references on SGA proportions. Results reinforced the importance of qualified GA to mitigate the impact on perinatal statistics. TRIAL REGISTRATION: Registration number PROSPERO: CRD42020184646.
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Nacimiento Prematuro , Embarazo , Lactante , Femenino , Recién Nacido , Humanos , Edad Gestacional , Nacimiento Prematuro/epidemiología , Recien Nacido Prematuro , Recién Nacido Pequeño para la Edad Gestacional , Retardo del Crecimiento FetalRESUMEN
BACKGROUND: Early access to antenatal care and high-cost technologies for pregnancy dating challenge early neonatal risk assessment at birth in resource-constrained settings. To overcome the absence or inaccuracy of postnatal gestational age (GA), we developed a new medical device to assess GA based on the photobiological properties of newborns' skin and predictive models. OBJECTIVE: This study aims to validate a device that uses the photobiological model of skin maturity adjusted to the clinical data to detect GA and establish its accuracy in discriminating preterm newborns. METHODS: A multicenter, single-blinded, and single-arm intention-to-diagnosis clinical trial evaluated the accuracy of a novel device for the detection of GA and preterm newborns. The first-trimester ultrasound, a second comparator ultrasound, and data regarding the last menstrual period (LMP) from antenatal reports were used as references for GA at birth. The new test for validation was performed using a portable multiband reflectance photometer device that assessed the skin maturity of newborns and used machine learning models to predict GA, adjusted for birth weight and antenatal corticosteroid therapy exposure. RESULTS: The study group comprised 702 pregnant women who gave birth to 781 newborns, of which 366 (46.9%) were preterm newborns. As the primary outcome, the GA as predicted by the new test was in line with the reference GA that was calculated by using the intraclass correlation coefficient (0.969, 95% CI 0.964-0.973). The paired difference between predicted and reference GAs was -1.34 days, with Bland-Altman limits of -21.2 to 18.4 days. As a secondary outcome, the new test achieved 66.6% (95% CI 62.9%-70.1%) agreement with the reference GA within an error of 1 week. This agreement was similar to that of comparator-LMP-GAs (64.1%, 95% CI 60.7%-67.5%). The discrimination between preterm and term newborns via the device had a similar area under the receiver operating characteristic curve (0.970, 95% CI 0.959-0.981) compared with that for comparator-LMP-GAs (0.957, 95% CI 0.941-0.974). In newborns with absent or unreliable LMPs (n=451), the intent-to-discriminate analysis showed correct preterm versus term classifications with the new test, which achieved an accuracy of 89.6% (95% CI 86.4%-92.2%), while the accuracy for comparator-LMP-GA was 69.6% (95% CI 65.3%-73.7%). CONCLUSIONS: The assessment of newborn's skin maturity (adjusted by learning models) promises accurate pregnancy dating at birth, even without the antenatal ultrasound reference. Thus, the novel device could add value to the set of clinical parameters that direct the delivery of neonatal care in birth scenarios where GA is unknown or unreliable. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-027442.
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Anomalías Múltiples , Recien Nacido Prematuro , Femenino , Edad Gestacional , Humanos , Recién Nacido , Aprendizaje Automático , Parto , EmbarazoRESUMEN
BACKGROUND: The development and maturation of the skin is a process that occurs during the gestation and neonatal period. Histological skin biopsy studies are relevant to improve knowledge on the skin protective barrier during the perinatal period. The thin skin of preterm newborns is unable to maintain homeostasis, thermal regulation through the skin, and is susceptible to infections. This study systematically reviewed the evidence regarding histological thickness dimensions of the skin and its layers during the late-fetal and neonatal period. METHODS: PubMed, Scopus, BVS, and e SciELO library databases, with no limits in the period of analysis or idiom. Eligibility criteria were as follows: studies describing the thickness of the entire skin or its layers during late-fetal life or the neonatal period; human being; skin biopsy analysis; and any scientific report. Two independent reviewers screened the search and extracted the following standard data: fetal or neonatal age of assessment, biopsy site, technique used for preparation and staining of histological slides, measurement techniques, and values of skin thickness. RESULTS: Fifty-nine studies were screened, and eleven were identified from other sources. We recognized six studies that met the criteria for inclusion for proper extraction. Expressive differences between sites for sampling, methods of slide preparation, and number of layers measured made the thicknesses values summarization difficult. There were no reliable dimensions reported on this tissue. CONCLUSION: Despite the importance of studying the human skin barrier, these findings confirmed limited evidence on skin thickness dimensions obtained by histology.
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Desarrollo Fetal/fisiología , Feto/diagnóstico por imagen , Técnicas Histológicas/métodos , Piel/diagnóstico por imagen , Piel/crecimiento & desarrollo , Femenino , Edad Gestacional , Humanos , Recién Nacido , Embarazo , Diagnóstico PrenatalRESUMEN
Background: A handheld optical device was developed to evaluate a newborn's skin maturity by assessing the photobiological properties of the tissue and processing it with other variables to predict early neonatal prognosis related to prematurity. This study assessed the device's ability to predict respiratory distress syndrome (RDS). Methods: To assess the device's utility we enrolled newborns at childbirth in six urban perinatal centers from two multicenter single-blinded clinical trials. All newborns had inpatient follow-up until 72â h of life. We trained supervised machine learning models with data from 780 newborns in a Brazilian trial and provided external validation with data from 305 low-birth-weight newborns from another trial that assessed Brazilian and Mozambican newborns. The index test measured skin optical reflection with an optical sensor and adjusted acquired values with clinical variables such as birth weight and prenatal corticoid exposition for lung maturity, maternal diabetes, and hypertensive disturbances. The performance of the models was evaluated using intrasample k-parts cross-validation and external validation in an independent sample. Results: Models adjusting three predictors (skin reflection, birth weight, and antenatal corticoid exposure) or five predictors had a similar performance, including or not maternal diabetes and hypertensive diseases. The best global accuracy was 89.7 (95% CI: 87.4 to 91.8, with a high sensitivity of 85.6% (80.2 to 90.0) and specificity of 91.3% (95% CI: 88.7 to 93.5). The test correctly discriminated RDS newborns in external validation, with 82.3% (95% CI: 77.5 to 86.4) accuracy. Our findings demonstrate a new way to assess a newborn's lung maturity, providing potential opportunities for earlier and more effective care. Trial registration: RBR-3f5bm5 (online access: http://www.ensaiosclinicos.gov.br/rg/RBR-3f5bm5/), and RBR-33mjf (online access: https://ensaiosclinicos.gov.br/rg/RBR-33rnjf/).
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Introduction: A new medical device was previously developed to estimate gestational age (GA) at birth by processing a machine learning algorithm on the light scatter signal acquired on the newborn's skin. The study aims to validate GA calculated by the new device (test), comparing the result with the best available GA in newborns with low birth weight (LBW). Methods: We conducted a multicenter, non-randomized, and single-blinded clinical trial in three urban referral centers for perinatal care in Brazil and Mozambique. LBW newborns with a GA over 24 weeks and weighing between 500 and 2,500â g were recruited in the first 24â h of life. All pregnancies had a GA calculated by obstetric ultrasound before 24 weeks or by reliable last menstrual period (LMP). The primary endpoint was the agreement between the GA calculated by the new device (test) and the best available clinical GA, with 95% confidence limits. In addition, we assessed the accuracy of using the test in the classification of preterm and SGA. Prematurity was childbirth before 37 gestational weeks. The growth standard curve was Intergrowth-21st, with the 10th percentile being the limit for classifying SGA. Results: Among 305 evaluated newborns, 234 (76.7%) were premature, and 139 (45.6%) were SGA. The intraclass correlation coefficient between GA by the test and reference GA was 0.829 (95% CI: 0.785-0.863). However, the new device (test) underestimated the reference GA by an average of 2.8 days (95% limits of agreement: -40.6 to 31.2 days). Its use in classifying preterm or term newborns revealed an accuracy of 78.4% (95% CI: 73.3-81.6), with high sensitivity (96.2%; 95% CI: 92.8-98.2). The accuracy of classifying SGA newborns using GA calculated by the test was 62.3% (95% CI: 56.6-67.8). Discussion: The new device (test) was able to assess GA at birth in LBW newborns, with a high agreement with the best available GA as a reference. The GA estimated by the device (test), when used to classify newborns on the first day of life, was useful in identifying premature infants but not when applied to identify SGA infants, considering current algohrithm. Nonetheless, the new device (test) has the potential to provide important information in places where the GA is unknown or inaccurate.
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OBJECTIVE: The structural maturation of the skin is considered a potential marker of pregnancy dating. This study investigated the correlation between the morphometrical skin characteristics with the pregnancy chronology to propose models for predicting gestational age. METHODS: A cross-sectional analysis selected 35 corpses of newborns. The biopsy was performed up to 48 hours after death in the periumbilical abdomen, palm and sole regions. Pregnancy chronology was based on the obstetric ultrasound before 14 weeks. The dimensions of the skin layers, area of glands and connective fibrous tissue were measured with imaging software support. Univariate and multivariate regression models on morphometric values were used to predict gestational age. RESULTS: Gestational age at birth ranged from 20.3 to 41.2 weeks. Seventy-one skin specimens resulted in the analysis of 1183 digital histological images. The correlation between skin thickness and gestational age was positive and strong in both regions of the body. The highest univariate correlation between gestational age and skin thickness was using the epidermal layer dimensions, in palm (r=0.867, p<0.001). The multivariate modelling with the thickness of the abdominal epidermis, the dermis and the area of the sebaceous glands adjusted had the highest correlation with gestational age (r=0.99, p<0.001). CONCLUSION: The thickness of the protective epidermal barrier is, in itself, a potential marker of pregnancy dating. However, sets of values obtained from skin morphometry enhanced the estimation of the gestational age. Such findings may support non-invasive image approaches to estimate pregnancy dating with various clinical applications.
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Parto , Piel , Estudios Transversales , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Embarazo , Piel/diagnóstico por imagen , Ultrasonografía PrenatalRESUMEN
BACKGROUND: The correct dating of pregnancy is critical to support timely decisions and provide obstetric care during birth. The early obstetric ultrasound assessment before 14 weeks is considered the best reference to assist in determining gestational age (GA), with an accuracy of ±5 to 7 days. However, this information is limited in many settings worldwide. OBJECTIVE: The aim of this study is to analyze the association between the obstetric interventions during childbirth and the quality of GA determination, according to the first antenatal ultrasound assessment, which assisted the calculation. METHODS: This is a hospital-based cohort study using medical record data of 2113 births at a perinatal referral center. The database was separated into groups and subgroups of analyses based on the reference used by obstetricians to obtain GA at birth. Maternal and neonatal characteristics, mode of delivery, oxytocin augmentation, and forceps delivery were compared between groups of pregnancies with GA determination at different reference points: obstetric ultrasound assessment 14 weeks, 20 weeks, and ≥20 weeks or without antenatal ultrasound (suboptimal dating). Ultrasound-based GA information was associated with outcomes between the interest groups using chi-square tests, odds ratios (OR) with 95% CI, or the Mann-Whitney statistical analysis. RESULTS: The chance of nonspontaneous delivery was higher in pregnancies with 14 weeks ultrasound-based GA (OR 1.64, 95% CI 1.35-1.98) and 20 weeks ultrasound-based GA (OR 1.58, 95% CI 1.31-1.90) when compared to the pregnancies with ≥20 weeks ultrasound-based GA or without any antenatal ultrasound. The use of oxytocin for labor augmentation was higher for 14 weeks and 20 weeks ultrasound-based GA, OR 1.41 (95% CI 1.09-1.82) and OR 1.34 (95% CI 1.04-1.72), respectively, when compared to those suboptimally dated. Moreover, maternal blood transfusion after birth was more frequent in births with suboptimal ultrasound-based GA determination (20/657, 3.04%) than in the other groups (14 weeks ultrasound-based GA: 17/1163, 1.46%, P=.02; 20 weeks ultrasound-based GA: 25/1456, 1.71%, P=.048). Cesarean section rates between the suboptimal dating group (244/657, 37.13%) and the other groups (14 weeks: 475/1163, 40.84%, P=.12; 20 weeks: 584/1456, 40.10%, P=.20) were similar. In addition, forceps delivery rates between the suboptimal dating group (17/657, 2.6%) and the other groups (14 weeks: 42/1163, 3.61%, P=.24; 20 weeks: 46/1456, 3.16%, P=.47) were similar. Neonatal intensive care unit admission was more frequent in newborns with suboptimal dating (103/570, 18.07%) when compared with the other groups (14 weeks: 133/1004, 13.25%, P=.01; 20 weeks: 168/1263, 13.30%, P=.01), excluding stillbirths and major fetal malformations. CONCLUSIONS: The present analysis highlighted relevant points of health care to improve obstetric assistance, confirming the importance of early access to technologies for pregnancy dating as an essential component of quality antenatal care.
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INTRODUCTION: Recognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn's skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant's skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings. METHODS AND ANALYSIS: Research protocol for diagnosis, single-group, single-blinding and single-arm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case-control study. ETHICS AND DISSEMINATION: Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings. TRIAL REGISTRATION NUMBER: RBR-3f5bm5.
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Recien Nacido Prematuro/fisiología , Tamizaje Neonatal , Óptica y Fotónica/instrumentación , Piel/fisiopatología , Brasil/epidemiología , Estudios de Casos y Controles , Femenino , Edad Gestacional , Humanos , Recién Nacido , Óptica y Fotónica/métodos , Embarazo , Estándares de Referencia , Fenómenos Fisiológicos de la PielRESUMEN
BACKGROUND: New methodologies to estimate gestational age (GA) at birth are demanded to face the limited access to obstetric ultrasonography and imprecision of postnatal scores. The study analyzed the correlation between neonatal skin thickness and pregnancy duration. Secondarily, it investigated the influence of fetal growth profiles on tissue layer dimensions. METHODS AND FINDINGS: In a feasibility study, 222 infants selected at a term-to-preterm ratio of 1:1 were assessed. Reliable information on GA was based on the early ultrasonography-based reference. The thicknesses of the epidermal and dermal skin layers were examined using high-frequency ultrasonography. We scanned the skin over the forearm and foot plantar surface of the newborns. A multivariate regression model was adjusted to determine the correlation of GA with skin layer dimensions. The best model to correlate skin thickness with GA was fitted using the epidermal layer on the forearm site, adjusted to cofactors, as follows: Gestational age (weeks) = -28.0 + 12.8 Ln (Thickness) - 4.4 Incubator staying; R2 = 0.604 (P<0.001). In this model, the constant value for the standard of fetal growth was statistically null. The dermal layer thickness on the forearm and plantar surfaces had a negative moderate linear correlation with GA (R = -0.370, P<0.001 and R = -0.421, P<0.001, respectively). The univariate statistical analyses revealed the influence of underweight and overweight profiles on neonatal skin thickness at birth. Of the 222 infants, 53 (23.9%) had inappropriate fetal growths expected for their GA. Epidermal thickness was not fetal growth standard dependent as follows: 172.2 (19.8) µm for adequate for GA, 171.4 (20.6) µm for SGA, and 177.7 (15.2) µm for LGA (P = 0.525, mean [SD] on the forearm). CONCLUSIONS: The analysis highlights a new opportunity to relate GA at birth to neonatal skin layer thickness. As this parameter was not influenced by the standard of fetal growth, skin maturity can contribute to clinical applications.
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Piel/diagnóstico por imagen , Ultrasonografía , Biometría , Peso al Nacer , Dermis/patología , Dermis/fisiología , Estudios de Factibilidad , Antebrazo/patología , Antebrazo/fisiología , Edad Gestacional , Humanos , Recién Nacido , Recien Nacido Prematuro , Piel/patología , Nacimiento a TérminoRESUMEN
BACKGROUND: Current methods to assess the gestational age during prenatal care or at birth are a global challenge. Disadvantages, such as low accessibility, high costs, and imprecision of clinical tests and ultrasonography measurements, may compromise health decisions at birth, based on the gestational age. Newborns' organs and tissues can indirectly indicate their physical maturity, and we hypothesized that evolutionary changes in their skin, detected using an optoelectronic device meter, may aid in estimating the gestational age. This study analyzed the feasibility of using newborn skin reflectance to estimate the gestational age at birth noninvasively. METHODS AND FINDINGS: A cross-sectional study evaluated the skin reflectance of selected infants, preferably premature, at birth. The first-trimester ultrasound was the reference for gestational age. A prototype of a new noninvasive optoelectronic device measured the backscattering of light from the skin, using a light emitting diode at wavelengths of 470 nm, 575 nm, and 630 nm. Univariate and multivariate regression analysis models were employed to predict gestational age, combining skin reflectance with clinical variables for gestational age estimation. The gestational age at birth of 115 newborns from 24.1 to 41.8 weeks of gestation correlated with the light at 630 nm wavelength reflectance 3.3 mm/6.5 mm ratio distant of the sensor, at the forearm and sole (Pearson's correlation = 0.505, P < 0.001 and 0.710, P < 0.001, respectively). The best-combined variables to predict the gold standard gestational age at birth was the skin reflectance at wavelengths of 630 nm and 470 nm in combination with birth weight, phototherapy, and adjusted to include incubator stay, and sex (R2 = 0.828, P < 0.001). The main limitation of the study is that it was very specific to the premature population we studied and needs to be studied in a broader spectrum of newborns. CONCLUSIONS: A novel automated skin reflectometer device, in combination with clinical variables, was able to predict the gestational age and could be useful when the information is in doubt or is unknown. Multivariable predictive models associated the skin reflectance with easy to obtain clinical parameters, at the birth scenario. External validation needs to be proven in an actual population with the real incidence of premature infants.
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Edad Gestacional , Recien Nacido Prematuro , Óptica y Fotónica/métodos , Piel/fisiopatología , Peso al Nacer , Estudios Transversales , Femenino , Humanos , Recién Nacido , Óptica y Fotónica/instrumentación , Embarazo , Fenómenos Fisiológicos de la PielRESUMEN
PURPOSE: To analyze the relationships among gestational risk, type of delivery and immediate maternal and neonatal repercussions. METHODS: A retrospective cohort study based on secondary data was conducted in a university maternity hospital. A total of 1606 births were analyzed over a 9-month period. Epidemiological, clinical, obstetric and neonatal characteristics were compared according to the route of delivery and the gestational risk characterized on the basis of the eligibility criteria for high clinical risk. The occurrence of maternal and neonatal complications during hospitalization was analyzed according to gestational risk and cesarean section delivery using univariate and multivariate logistic analysis. RESULTS: The overall rate of cesarean sections was 38.3%. High gestational risk was present in 50.2% of births, mainly represented by hypertensive disorders and fetal malformations. The total incidence of cesarean section, planned cesarean section or emergency cesarean section was more frequent in pregnant women at gestational high risk (p<0.001). Cesarean section alone did not influence maternal outcome, but was associated with poor neonatal outcome (OR 3.4; 95%CI 2.7-4.4). Gestational high risk was associated with poor maternal and neonatal outcome (OR 3.8; 95%CI 1.3-8.7 and OR 17.5; 95%CI 11.6-26.3, respectively). In multivariate analysis, the ratios were maintained, although the effect of gestational risk has determined a reduction in the OR of the type of delivery alone from 3.4 (95%CI 2.7-4.4) to 1.99 (95%CI 1.5-2.6) for adverse neonatal outcome. CONCLUSION: Gestational risk was the main factor associated with poor maternal and neonatal outcome. Cesarean delivery was not directly associated with poor maternal outcome but increased the chances of unfavorable neonatal outcomes.
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Parto Obstétrico , Complicaciones del Embarazo/epidemiología , Resultado del Embarazo , Adolescente , Adulto , Cesárea , Estudios de Cohortes , Femenino , Humanos , Recién Nacido , Persona de Mediana Edad , Embarazo , Estudios Retrospectivos , Riesgo , Adulto JovenRESUMEN
OBJETIVO: Avaliar as relações entre risco gestacional, tipo de parto e suas repercussões maternas e neonatais imediatas. MÉTODOS: Análise retrospectiva de coorte em base de dados secundários, em maternidade de hospital universitário. Foram considerados 1606 partos no período de nove meses. Características epidemiológicas, clínicas, obstétricas e neonatais foram comparadas em função da via de parto e do risco gestacional, caracterizado conforme os critérios de elegibilidade de alto risco clínico. A ocorrência de complicações maternas e neonatais durante a internação foi analisada em função do risco gestacional e parto cesariano. Para isto, análise logística univariada e multivariada foram empregadas. RESULTADOS: A taxa global de cesarianas foi de 38,3%. O alto risco gestacional esteve presente em 50,2% dos partos, representado principalmente pelos distúrbios hipertensivos e as malformações fetais. A ocorrência total de cesarianas, cesarianas anteparto ou intraparto foi mais frequente em gestantes de elevado risco gestacional (p<0,001]. A cesariana, isoladamente, não influenciou o resultado materno, mas associou-se ao resultado neonatal desfavorável (OR 3,4; IC95% 2,7-4,4). O alto risco gestacional associou-se ao resultado materno e neonatal desfavorável (OR 3,8; IC95% 1,6-8,7 e OR 17,5; IC95% 11,6-26,3, respectivamente) Na análise multivariada, essas relações de risco se mantiveram, embora o efeito do risco gestacional tenha determinado uma redução no OR do tipo de parto isoladamente de 3,4 (IC95% 2,66-4,4) para 1,99 (IC95% 1,5-2,6) para o resultado neonatal desfavorável. CONCLUSÃO: O risco gestacional foi o principal fator associado ao resultado materno e neonatal desfavorável. A cesariana não influenciou diretamente ...
PURPOSE: To analyze the relationships among gestational risk, type of delivery and immediate maternal and neonatal repercussions. METHODS: A retrospective cohort study based on secondary data was conducted in a university maternity hospital. A total of 1606 births were analyzed over a 9-month period. Epidemiological, clinical, obstetric and neonatal characteristics were compared according to the route of delivery and the gestational risk characterized on the basis of the eligibility criteria for high clinical risk. The occurrence of maternal and neonatal complications during hospitalization was analyzed according to gestational risk and cesarean section delivery using univariate and multivariate logistic analysis. RESULTS: The overall rate of cesarean sections was 38.3%. High gestational risk was present in 50.2% of births, mainly represented by hypertensive disorders and fetal malformations. The total incidence of cesarean section, planned cesarean section or emergency cesarean section was more frequent in pregnant women at gestational high risk (p<0.001). Cesarean section alone did not influence maternal outcome, but was associated with poor neonatal outcome (OR 3.4; 95%CI 2.7-4.4). Gestational high risk was associated with poor maternal and neonatal outcome (OR 3.8; 95%CI 1.3-8.7 and OR 17.5; 95%CI 11.6-26.3, respectively). In multivariate analysis, the ratios were maintained, although the effect of gestational risk has determined a reduction in the OR of the type of delivery alone from 3.4 (95%CI 2.7-4.4) to 1.99 (95%CI 1.5-2.6) for adverse neonatal outcome. CONCLUSION: Gestational risk was the main factor associated with poor maternal and neonatal outcome. Cesarean delivery was not directly associated with poor maternal outcome but increased the chances of unfavorable neonatal outcomes. .