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BACKGROUND AND AIMS: Good glycemic control is crucial to reduce the risk of adverse pregnancy outcomes. Our aim was to evaluate the efficacy of Flash Glucose Monitoring (FGM) on glucose control in women with pregestational diabetes. METHODS AND RESULTS: Forty women with inadequately controlled type 1 (T1D, n = 34) and type 2 (T2D, n = 6) diabetes at conception were randomly assigned to two arms: the Flash Glucose group (FG, n = 21) using FGM, and the control group (CG, n = 19) using self-monitoring of blood glucose (SMBG). Glycated hemoglobin (HbA1c, %), time in (TIR), below (TBR) and above (TAR) range, glucose variability as well as the occurrence of maternal and neonatal adverse outcomes, were evaluated. HbA1c decreased significantly (p < 0.01) and similarly (-0.65 ± 0.7 vs. -0.67 ± 0.8 for FG and CG, respectively; p = 0.89) in both groups during pregnancy. HbA1c reduction was positively associated with the number of daily FGM scans (p < 0.01). TBR (12.1 ± 2.0% vs. 19.6 ± 3.9%, p = 0.04) and the mean of the daily serum glucose difference (MODD) index (59.1 ± 5.4 vs. 77.7 ± 4.6, p = 0.02) were significantly lower in FG at second trimester. The rates of perinatal adverse outcomes were not different in the two studied groups. CONCLUSIONS: In women with pregestational diabetes, FGM and SMBG had similar efficacy on glucose control during pregnancy. FGM showed additional advantages in terms of TBR and glucose variability. Achievement of good metabolic results depended on the adequate use of glucose sensor. REGISTRATION: At ClinicalTrials.gov as NCT04666818 on December 14, 2020.
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Automonitorización de la Glucosa Sanguínea/instrumentación , Glucemia/efectos de los fármacos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Control Glucémico/instrumentación , Hipoglucemiantes/uso terapéutico , Embarazo en Diabéticas , Adulto , Biomarcadores/sangre , Glucemia/metabolismo , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Femenino , Humanos , Hipoglucemia/sangre , Hipoglucemia/inducido químicamente , Hipoglucemia/prevención & control , Hipoglucemiantes/efectos adversos , Italia , Proyectos Piloto , Valor Predictivo de las Pruebas , Embarazo , Estudios Prospectivos , Resultado del TratamientoRESUMEN
AIM: In response to the COVID-19 pandemic, there is a need for substantial changes in the procedures for accessing healthcare services. Even in the current pandemic, we should not reduce our attention towards the diagnosis and treatment of GDM. The purpose of this document is to provide a temporary guide for GDM screening, replacing the current guidelines when it is not possible to implement standard GDM screening because of an unfavorable risk/benefit ratio for pregnant women or when usual laboratory facilities are not available. DATA SYNTHESIS: At the first visit during pregnancy, we must exclude the presence of "Overt diabetes" in all women. The criteria for the diagnosis of overt diabetes are either fasting plasma glucose ≥126 mg/dL, or random plasma glucose ≥200 mg/dL, or glycated hemoglobin ≥6.5%. When the screening procedure (OGTT) cannot be safely performed, the diagnosis of GDM is acceptable if fasting plasma glucose is ≥ 92 mg/dL. In order to consider the impaired fasting glucose as an acceptable surrogate for the diagnosis of GDM, the fasting glucose measurement should be performed within the recommended time windows for the risk level (high or medium risk). CONCLUSIONS: The changes to the screening procedure for GDM reported below are specifically produced in response to the health emergency of the COVID-19 pandemic. Therefore, these recommended changes should cease to be in effect and should be replaced by current national guidelines when the healthcare authorities declare the end of this emergency.
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Betacoronavirus , Infecciones por Coronavirus/epidemiología , Diabetes Gestacional/diagnóstico , Neumonía Viral/epidemiología , Glucemia/análisis , COVID-19 , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Italia , Pandemias , Embarazo , SARS-CoV-2RESUMEN
BACKGROUND: This study aims to evaluate: 1) the prevalence of Female Sexual Dysfunction (FSD) in women affected by type 1 Diabetes Mellitus (DM) and the control group; 2) the correlation between duration of DM, HbA1C levels and sexual life quality; 3) the relationship between different methods of insulin administration and sexual life quality; 4) the correlation between FSD and diabetes complications. METHODS: We selected 33 women with type 1 DM and 39 healthy women as controls. Each participant underwent a detailed medical history and physical examination and completed the 6-item Female Sexual Function Index questionnaire (FSFI-6). In patients affected by type 1 DM, the different methods of insulin administration (Multi Drug Injection - MDI or Continuous Subcutaneous Insulin Infusion - CSII) and the presence of DM complications were also investigated. RESULTS: The prevalence of FSD (total score ≤ 19) was significantly higher in the type 1 DM group than in the control group (12/33, 36.4% and 2/39, 5.2%, respectively; p = 0.010). No statistically significant differences were found regarding FSD according to the presence of complications, method of insulin administration or previous pregnancies. CONCLUSIONS: This study underlined that FSD is higher in women affected by type 1 DM than in healthy controls. This could be due to the diabetic neuropathy/angiopathy and the type of insulin administration. Therefore, it is important to investigate FSD in diabetic women, as well as erectile dysfunction in diabetic men.
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Diabetes Mellitus Tipo 1/complicaciones , Disfunciones Sexuales Fisiológicas/etiología , Adulto , Estudios de Casos y Controles , Diabetes Mellitus Tipo 1/epidemiología , Femenino , Humanos , Obesidad/complicaciones , Prevalencia , Calidad de Vida , Conducta Sexual , Disfunciones Sexuales Fisiológicas/epidemiología , Encuestas y CuestionariosRESUMEN
Pregnancy induces a deep modification of women's gut microbiota composition. These changes may influence hormonal and metabolic factors, increasing insulin resistance and leading to hyperglycaemia in susceptible women. Data on 29 women in pregnancy showed insignificant reductions in the Bacteroidetes/ Firmicutes ratio in women with (n. 14) and without (n. 15) gestational diabetes (GDM). Gut microbiota compositions at the genera and species level were further analysed in ten pregnant women with and ten without GDM (9 samples were excluded due to low DNA quality/quantity), showing differences in functionally specific patterns affecting host energy dietary polysaccharide metabolism pathways. According to our results, gut microbiome alteration may play a role in GDM pathogenesis through an increase of gut permeability and higher intestinal energetic balance.
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Biodiversidad , Diabetes Gestacional , Microbioma Gastrointestinal , Diabetes Gestacional/microbiología , Femenino , Humanos , Resistencia a la Insulina , Proyectos Piloto , EmbarazoAsunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/prevención & control , Diabetes Gestacional/epidemiología , Diabetes Gestacional/prevención & control , Femenino , Estudios de Seguimiento , Humanos , Italia , Embarazo , Prevención Primaria , Factores de RiesgoRESUMEN
AIMS: To assess the GDM recurrence rate in a cohort of pregnant women with prior GDM, to compare two consecutive pregnancies complicated by GDM, to compare women with nonrecurrent and recurrent GDM and to stratify the latter in women with early and late recurrent GDM. METHODS: Retrospective study including 113 women with GDM in an index pregnancy (G1), at least a postindex pregnancy (G2) and normal glucose tolerance in between. The GDM recurrence rate was assessed, and maternal and neonatal outcomes and pancreatic beta cell function of the index pregnancy were compared with those of the postindex pregnancy (G1 vs. G2). Women with nonrecurrent GDM were compared with those with recurrent GDM. RESULTS: The GDM recurrence rate was 83.2% and the minimum prevalence of early recurrent GDM was 43,4%. The pregravid BMI of women with recurrent GDM increased between the two pregnancies (27.3 ± 5.98 vs. 28.1 ± 6.19 kg/m2, p < 0.05). Women with recurrent GDM had a higher prepregnancy BMI than those with nonrecurrent GDM either at the index (27.3 ± 5.98 vs. 23.1 ± 4.78 kg/m2, p < 0.05) or the postindex pregnancy (27 ± 6vs.24 ± 4,4 kg/m2, p < 0.05). CONCLUSIONS: GDM shows a high recurrence rate in our cohort of slightly overweight women, with an early GDM minimum prevalence of 43.4%.
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Diabetes Gestacional , Índice de Masa Corporal , Diabetes Gestacional/epidemiología , Diabetes Gestacional/etiología , Femenino , Humanos , Recién Nacido , Masculino , Embarazo , Prevalencia , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Aim: The primary aim of this study was to assess insulin requirements and carbohydrate to insulin ratio (CHO/IR) in normal weight, overweight, and obese pregnant women with type 1 diabetes across early, middle, and late pregnancy. Methods: In this multicenter, retrospective, observational study we evaluated 86 of 101 pregnant Caucasian women with type 1 diabetes under pump treatment. The women were trained to calculate CHO/IR daily by dividing CHO grams of every single meal by insulin units injected. Since the purpose of the study was to identify the CHO/IR able to reach the glycemic target, we only selected the CHO/IR obtained when glycemic values were at target. Statistics: SPSS 20. Results: We studied 45 normal weight, 31 overweight, and 10 obese women. Insulin requirements increased throughout pregnancy (p < 0.0001 and <0.001 respectively) in the normal and overweight women, while it remained unchanged in the obese women. Insulin requirements were different between groups when expressed as an absolute value, but not when adjusted for body weight. Breakfast CHO/IR decreased progressively throughout pregnancy in the normal weight women, from 13.3 (9.8-6.7) at the first stage of pregnancy to 6.2 (3.8-8.6) (p = 0.01) at the end stage, and in the overweight women from 8.5 (7.1-12.6) to 5.2 (4.0-8.1) (p = 0.001), while in the obese women it remained stable, moving from 6.0 (5.0-7.9) to 5.1 (4.1-7.4) (p = 0.7). Likewise, lunch and dinner CHO/IR decreased in the normal weight and overweight women (p < 0.03) and not in the obese women. The obese women gained less weight than the others, especially in early pregnancy when they even lost a median of 1.25 (-1 -1.1) kg (p = 0.005). In early pregnancy, we found a correlation between pregestational BMI and insulin requirements (IU/day) or CHO/IR at each meal (p < 0.001 and p = 0.001, respectively). In late pregnancy, a relationship between pre-gestational BMI and CHO/IR change was found (P = 0.004), as well as between weight gain and CHO/IR change (p=0.02). The significance was lost when both variables were included in the multiple regression analysis. There was no difference in pregnancy outcomes except for a higher pre-term delivery rate in the obese women. Conclusion: Pre-gestational BMI and weight gain may play a role in determining CHO/IR during pregnancy in women with type 1 diabetes under pump treatment.
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Diabetes Mellitus Tipo 1/terapia , Carbohidratos de la Dieta/administración & dosificación , Insulina/administración & dosificación , Embarazo en Diabéticas , Adulto , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 1/epidemiología , Cálculo de Dosificación de Drogas , Femenino , Edad Gestacional , Humanos , Peso Corporal Ideal/fisiología , Sistemas de Infusión de Insulina , Italia/epidemiología , Comidas , Necesidades Nutricionales , Obesidad/sangre , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/terapia , Sobrepeso/sangre , Sobrepeso/complicaciones , Sobrepeso/epidemiología , Sobrepeso/terapia , Embarazo , Complicaciones del Embarazo/sangre , Complicaciones del Embarazo/epidemiología , Complicaciones del Embarazo/terapia , Resultado del Embarazo/epidemiología , Embarazo en Diabéticas/sangre , Embarazo en Diabéticas/tratamiento farmacológico , Embarazo en Diabéticas/epidemiología , Estudios Retrospectivos , Adulto JovenRESUMEN
AIMS: To assess the proportion of women with gestational diabetes (GDM) by performing postpartum Oral Glucose Tolerance Test (OGTT) and to identify GDM phenotypes at high-risk of postpartum dysglycemia (PPD). METHODS: Observational, retrospective, multicenter study involving consecutive GDM women. Recursive partitioning (RECPAM) analysis was used to identify distinct and homogeneous subgroups of women at different PPD risk. RESULTS: From a sample of 2,736 women, OGTT was performed in 941 (34.4%) women, of whom 217 (23.0%) developed PPD. Insulin-treated women having family history of diabetes represented the subgroup with the highest PPD risk (OR 5.57, 95% CI 3.60-8.63) compared to the reference class (women on diet with pre-pregnancy BMI < = 28.1 kg/m2). Insulin-treated women without family diabetes history and women on diet with pre-pregnancy BMI > 28.1 kg/m2 showed a two-fold PPD risk. Previous GDM and socioeconomic status represent additional predictors. Fasting more than post-prandial glycemia plays a predictive role, with values of 81-87 mg/dl (4.5-4.8 mmol/l) (lower than the current diagnostic GDM threshold) being associated with PPD risk. CONCLUSIONS: Increasing compliance to postpartum OGTT to prevent/delay PPD is a priority. Easily available characteristics identify subgroups of women more likely to benefit from preventive strategies. Fasting BG values during pregnancy lower than those usually considered deserve attention.
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Diabetes Gestacional , Adulto , Glucemia , Diabetes Gestacional/diagnóstico , Diabetes Gestacional/epidemiología , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Periodo Posparto , Embarazo , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Introduction: The prevalence among pregnant women with diabetes of monogenic diabetes due to glucokinase deficit (GCK-MODY) varies from 0 to 80% in different studies, based on the chosen selection criteria for genetic test. New pregnancy-specific Screening Criteria (NSC), validated on an Anglo-Celtic pregnant cohort, have been proposed and include pre-pregnancy BMI <25 kg/m2 and fasting glycemia >99 mg/dl. Our aim was to estimate the prevalence of GCK-MODY and to evaluate the diagnostic performance of NSC in our population of women with diabetes in pregnancy. Patients and Methods: We retrospectively selected from our database of 468 diabetic pregnant patients in Sant'Andrea Hospital, in Rome, from 2010 to 2018, all the women who received a genetic test for GCK deficit because of specific clinical features. We estimated the prevalence of GCK-MODY among tested women and the minimum prevalence in our entire population with non-autoimmune diabetes. We evaluated diagnostic performance of NSC on the tested cohort and estimated the eligibility to genetic test based on NSC in the entire population. Results: A total of 409 patients had diabetes in pregnancy, excluding those with autoimmune diabetes; 21 patients have been tested for GCK-MODY, 8 have been positive and 13 have been negative (2 of them had HNF1-alfa mutations and 1 had HNF4-alfa mutation). We found no significant differences in clinical features between positive and negative groups except for fasting glycemia, which was higher in the positive group. The minimum prevalence of monogenic diabetes in our population was 2.4%. The minimum prevalence of GCK-MODY was 1.95%. In the tested cohort, the prevalence of GCK-MODY was 38%. In this group, NSC sensitivity is 87% and specificity is 30%, positive predictive value is 43%, and negative predictive value is 80%. Applying NSC on the entire population of women with non-autoimmune diabetes in pregnancy, 41 patients (10%) would be eligible for genetic test; considering a fasting glycemia >92 mg/dl, 85 patients (20.7%) would be eligible. Discussion: In our population, NSC have good sensitivity but low specificity, probably because there are many GDM with GCK-MODY like features. It is mandatory to define selective criteria with a good diagnostic performance on Italian population, to avoid unnecessary genetic tests.
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Diabetes Mellitus Tipo 2/epidemiología , Diabetes Gestacional/epidemiología , Glucoquinasa/deficiencia , Mutación , Embarazo en Diabéticas/epidemiología , Adulto , Biomarcadores/análisis , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/enzimología , Diabetes Mellitus Tipo 2/genética , Diabetes Gestacional/sangre , Diabetes Gestacional/enzimología , Diabetes Gestacional/genética , Femenino , Estudios de Seguimiento , Pruebas Genéticas , Glucoquinasa/genética , Humanos , Italia/epidemiología , Embarazo , Embarazo en Diabéticas/sangre , Embarazo en Diabéticas/enzimología , Embarazo en Diabéticas/genética , Prevalencia , Pronóstico , Estudios RetrospectivosRESUMEN
Many specialists use the remote management of people with chronic disease as diabetes, but structured management protocols have not been developed yet. The COVID-19 pandemic has given a big boost to the use of telemedicine, as it allows to maintain the physical distance, essential to the containment of contagion having regular health contact. Encouraging results related to the use of telemedicine in women with hyperglycaemia in pregnancy, have been recently published. It is well known that hyperglycaemia alters the immune response to infections, that inflammation, in turn, worsens glycaemic control and that any form of hyperglycaemia in pregnancy (HIP) has effects not only on the mother but also on development of the foetus. Therefore, the Italian Diabetes and Pregnancy Study Group, together with a group of experts, developed these recommendations in order to guide physicians in the management of HIP, providing specific diagnostic, therapeutic and assistance pathways (PDTAs) for the COVID-19 emergency. Three detailed PDTAs were developed, for type 1, type 2 and gestational diabetes.
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Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/prevención & control , Diabetes Gestacional/tratamiento farmacológico , Hiperglucemia/prevención & control , Insulina/uso terapéutico , Pandemias/prevención & control , Neumonía Viral/prevención & control , Guías de Práctica Clínica como Asunto/normas , Complicaciones Infecciosas del Embarazo/prevención & control , Glucemia/análisis , COVID-19 , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Diabetes Gestacional/fisiopatología , Diabetes Gestacional/virología , Manejo de la Enfermedad , Femenino , Humanos , Hiperglucemia/epidemiología , Hiperglucemia/virología , Hipoglucemiantes/uso terapéutico , Italia/epidemiología , Neumonía Viral/complicaciones , Neumonía Viral/epidemiología , Neumonía Viral/virología , Embarazo , Complicaciones Infecciosas del Embarazo/epidemiología , Complicaciones Infecciosas del Embarazo/virología , SARS-CoV-2 , Telemedicina/métodosRESUMEN
Mobile health (mHealth) applications (apps) have been recently introduced as an easily accessible tool for providing information to pregnant women with diabetes. Despite the growing number of apps on the topic "diabetes & pregnancy", a smartphone app offering comprehensive and individualized information to both women (before and during gestation) and their healthcare professionals was still missing. To overcome this lack, the Italian Diabetes and Pregnancy Study Group conceived and realized in 2016 a novel mobile app called "MySweetGestation". It is designed to be an interactive educational tool for both patients and physicians not expert in the field. Through an interactive way of learning, it provides validated information to the user, focusing on different area of interest: from prevention and risk factors for developing diabetes during pregnancy to treatment and follow-up strategies after gestation. Three years since its publication, MySweetGestation has been downloaded in different western and eastern countries worldwide, suggesting a widespread social impact. Easily accessible personalized information made available via mHealth technology may be of great importance to spread controlled information among the pregnant population. MySweetGestation, being an interactive educational device for both patients and healthcare professionals, may contribute to improve the management of pregnant women with diabetes.
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Diabetes Gestacional/epidemiología , Aplicaciones Móviles/tendencias , Telemedicina/tendencias , Femenino , Humanos , Embarazo , Factores de RiesgoRESUMEN
AIMS: In 2010, Italian health professionals rapidly implemented the one-step screening for gestational diabetes mellitus (GDM) based on a 75 g OGTT, to comply with the diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). The change was promoted by the two main Italian scientific societies of diabetology, Associazione Medici Diabetologi (AMD) and Società Italiana di Diabetologia (SID), and it took just a few months for the Istituto Superiore di Sanità, together with several scientific societies, to revise the criteria and include them in the National Guidelines System. Over the last 9 years, the implementation of these guidelines has shown some benefits and some drawbacks. METHODS: In order to evaluate the critical issues arisen from the implementation of the current Italian guidelines for the diagnosis of GDM, the studies published on this topic have been reviewed. The search was performed using the following keywords: "gestational diabetes" AND "diagnostic criteria" OR screening AND Ital*. The study is an expert opinion paper, based on the relevant scientific literature published between 2010 and 2019. The databases screened for the literature review included PubMed, MEDLINE, and Scopus. RESULTS: The implementation of the Guidelines for Screening and Diagnosis of GDM in Italy present some strengths and some weaknesses. One of the positive aspects is that high-risk women are required to perform an OGTT early in pregnancy. By contrast, there are several aspects in need of improvement: (1) In spite of the current indications, only a minority of high-risk women perform OGTT early in pregnancy; (2) several low-risk women are screened for GDM; (3) in some low-risk women affected by GDM, the diagnosis might be missed with the application of the current guidelines; (4) there is a lack of homogeneity in the risk assessment data from different regions. CONCLUSIONS: In order to improve the current Italian GDM guidelines, some practical solutions have been suggested.
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Diabetes Gestacional/diagnóstico , Guías de Práctica Clínica como Asunto , Adulto , Femenino , Humanos , Italia , Tamizaje Masivo/normas , EmbarazoRESUMEN
AIMS: This study monitored blood glucose profiles in normotolerant breastfeeding women, with and without previous gestational diabetes, in real life in order to identify normal blood glucose fluctuations during breastfeeding. SUBJECTS AND METHODS: Two groups were studied: (1) 18 women with recent gestational diabetes mellitus but normotolerant postpartum (pGDM-N group) and (2) 15 women normotolerant both during pregnancy and postpartum (pN-N group). All participants underwent continuous glucose monitoring during which they recorded their main daily activities and three standardized events: "suckling," "meal," and "meal and suckling." Other than these three events, these women were essentially on an "ad lib" diet. Data were expressed as median and SD values. Student's t test and Fisher's test were used to compare mean, variances, and percentages. Differences were significant with P<0.05. Clustering analysis was used to determine the normal range of glucose values. RESULTS: The two groups were matched for age, follow-up duration, and monitoring measurements but not for body mass index. Blood glucose levels and variances were higher in the pGDM-N group, particularly during daytime and the three standardized events, and were not related to body mass index. Suckling had no direct effect on glucose profile during both the non-fed and the fed state. Blood glucose levels that best represent the normal breastfeeding population were between 50 and 126 mg/dL (from 2.8 to 7.0 mmol/L). CONCLUSIONS: Three months after delivery, normotolerant women with recent gestational diabetes had higher daily blood glucose levels than women who were always normotolerant, with no direct effect of suckling. The blood glucose profiles of healthy subjects could be representative of the normal range of the population during breastfeeding.
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Automonitorización de la Glucosa Sanguínea/métodos , Glucemia/metabolismo , Lactancia Materna , Diabetes Gestacional/sangre , Adulto , Índice de Masa Corporal , Análisis por Conglomerados , Femenino , Prueba de Tolerancia a la Glucosa , Humanos , Recién Nacido , Periodo Posparto , Embarazo , Valores de Referencia , Factores de TiempoRESUMEN
Hypertensive disorders in pregnancy can be chronic, pregestational or just diagnosed before the 20th week, or newly diagnosed in the second half of pregnancy. Any type of hypertension is more frequent in diabetic pregnancies with a different distribution among different types of diabetes. Most of the evidence is for pre-eclampsia associated with a marked increase in primary caesarean section, preterm birth and more need for neonatal intensive care. Different risk factors and pregnancy outcomes would support the hypothesis that pre-eclampsia and gestational hypertension might be largely separate entities, but this position is not unanimously accepted. Chronic hypertension increases with age and duration of diabetes, predicting increased rates of prematurity and neonatal morbidity, especially when associated with superimposed pre-eclampsia. Long-term consequences are observed in women whose pregnancy was complicated by hypertension such as chronic hypertension and cardiovascular diseases.