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OBJECTIVE: To evaluate the perinatal and maternal outcomes of pregnancies in women infected with SARS-CoV-2, comparing spontaneous and in vitro fertilization (IVF) pregnancies (with either own or donor oocytes). DESIGN: Multicenter, prospective, observational study. SETTING: 78 centers participating in the Spanish COVID19 Registry. PATIENT(S): 1,347 pregnant women with SARS-CoV-2 positive results registered consecutively between February 26 and November 5, 2020. INTERVENTION(S): The patients' information was collected from their medical records, and multivariable regression analyses were performed, controlling for maternal age and the clinical presentation of the infection. MAIN OUTCOME MEASURE(S): Obstetrics and neonatal outcomes, pregnancy comorbidities, intensive care unit admission, mechanical ventilation need, and medical conditions. RESULT(S): The IVF group included 74 (5.5%) women whereas the spontaneous pregnancy group included 1,275 (94.5%) women. The operative delivery rate was high in all patients, especially in the IVF group, where cesarean section became the most frequent method of delivery (55.4%, compared with 26.1% of the spontaneous pregnancy group). The reason for cesarean section was induction failure in 56.1% of the IVF patients. IVF women had more gestational hypertensive disorders (16.2% vs. 4.5% among spontaneous pregnancy women, adjusted odds ratio [aOR] 5.31, 95% confidence interval [CI] 2.45-10.93) irrespective of oocyte origin. The higher rate of intensive care unit admittance observed in the IVF group (8.1% vs. 2.4% in the spontaneous pregnancy group) was attributed to preeclampsia (aOR 11.82, 95% CI 5.25-25.87), not to the type of conception. CONCLUSION(S): A high rate of operative delivery was observed in pregnant women infected with SARS-CoV-2, especially in those with IVF pregnancies; method of conception did not affect fetal or maternal outcomes, except for preeclampsia. CLINICAL TRIAL REGISTRATION NUMBER: NCT04558996.

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BACKGROUND: To determine whether severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, the cause of COVID-19 disease) exposure in pregnancy, compared to non-exposure, is associated with infection-related obstetric morbidity. METHODS: We conducted a multicentre prospective study in pregnancy based on a universal antenatal screening program for SARS-CoV-2 infection. Throughout Spain 45 hospitals tested all women at admission on delivery ward using polymerase-chain-reaction (PCR) for COVID-19 since late March 2020. The cohort of positive mothers and the concurrent sample of negative mothers was followed up until 6-weeks post-partum. Multivariable logistic regression analysis, adjusting for known confounding variables, determined the adjusted odds ratio (aOR) with 95% confidence intervals (95% CI) of the association of SARS-CoV-2 infection and obstetric outcomes. MAIN OUTCOME MEASURES: Preterm delivery (primary), premature rupture of membranes and neonatal intensive care unit admissions. RESULTS: Among 1009 screened pregnancies, 246 were SARS-CoV-2 positive. Compared to negative mothers (763 cases), SARS-CoV-2 infection increased the odds of preterm birth (34 vs 51, 13.8% vs 6.7%, aOR 2.12, 95% CI 1.32-3.36, p = 0.002); iatrogenic preterm delivery was more frequent in infected women (4.9% vs 1.3%, p = 0.001), while the occurrence of spontaneous preterm deliveries was statistically similar (6.1% vs 4.7%). An increased risk of premature rupture of membranes at term (39 vs 75, 15.8% vs 9.8%, aOR 1.70, 95% CI 1.11-2.57, p = 0.013) and neonatal intensive care unit admissions (23 vs 18, 9.3% vs 2.4%, aOR 4.62, 95% CI 2.43-8.94, p <  0.001) was also observed in positive mothers. CONCLUSION: This prospective multicentre study demonstrated that pregnant women infected with SARS-CoV-2 have more infection-related obstetric morbidity. This hypothesis merits evaluation of a causal association in further research.

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Around two percent of asymptomatic women in labor test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Spain. Families and care providers face childbirth with uncertainty. We determined if SARS-CoV-2 infection at delivery among asymptomatic mothers had different obstetric outcomes compared to negative patients. This was a multicenter prospective study based on universal antenatal screening for SARS-CoV-2 infection. A total of 42 hospitals tested women admitted for delivery using polymerase chain reaction, from March to May 2020. We included positive mothers and a sample of negative mothers asymptomatic throughout the antenatal period, with 6-week postpartum follow-up. Association between SARS-CoV-2 and obstetric outcomes was evaluated by multivariate logistic regression analyses. In total, 174 asymptomatic SARS-CoV-2 positive pregnancies were compared with 430 asymptomatic negative pregnancies. No differences were observed between both groups in key maternal and neonatal outcomes at delivery and follow-up, with the exception of prelabor rupture of membranes at term (adjusted odds ratio 1.88, 95% confidence interval 1.13-3.11; p = 0.015). Asymptomatic SARS-CoV-2 positive mothers have higher odds of prelabor rupture of membranes at term, without an increase in perinatal complications, compared to negative mothers. Pregnant women testing positive for SARS-CoV-2 at admission for delivery should be reassured by their healthcare workers in the absence of symptoms.

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La endometritis granulomatosa es una inflamación crónica que se define histológicamente por la presencia de granulomas en un endometrio con un infiltrado linfoplasmocitario. Su hallazgo en una biopsia o pieza de endometrio, debe hacer pensar en tuberculosis (TBC) genital. Esta TBC era una infección rara en la mujer, las localizaciones endometriales, tubárica y ovárica casi siempre secundaria de otra localización. Más rara en mujeres posmenopáusicas, se cree debida a la escasez de los cultivos del endometrio atrófico. El diagnóstico definitivo de TBC genital es el cultivo del bacilo de Koch. La presunción se puede hacer si aparecen granulomas en la biopsia y Mantoux positivo. Su tratamiento es médico y con buen pronóstico. Presentamos 5 casos clínicos en posmenopáusicas, diagnosticados entre junio de 2001 y abril de 2003

Granulomatous endometritis is a chronic inflammation histologically characterized by the presence of granulomas in an endometrium with lymphoplasmacytic infiltrate. A finding of granulomatous endometritis in the biopsy or endometrial specimen should lead to suspicion of genital tuberculosis. This infection used to be rare in women. Tubal, endometrial and ovarian localizations are almost always secondary to a focus in another location. This entity is less frequent in postmenopausal women, probably because the atrophic endometrium provides a poor environment for growth of the tuberculosis bacillus. The definitive diagnosis of genital tuberculosis is culture of the Koch bacillus. A presumptive diagnosis can be made on the basis of granulomas in biopsy and a positive Mantoux test. Treatment is medical and the prognosis is good. We present five cases of genital tuberculosis in postmenopausal women, diagnosed between June 2001 and April 2003

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BACKGROUND: Left ventricular hypertrophy is an important predictor of cardiovascular risk and its detection contributes to risk stratification. However, echocardiography is not a routine procedure and electrocardiography (ECG) underestimates its prevalence. OBJECTIVE: To evaluate the prevalence of echocardiographic left ventricular hypertrophy in low and medium risk non-treated hypertensive subjects, in order to find out the percentage of them who would be reclassified as high risk patients. METHODS: Cross-sectional, multicenter study was performed in hospital located hypertension units. An echocardiogram was performed in 197 previously untreated hypertensive patients, > 18 years, classified as having low (61%) or medium (39%) risk, according to the OMS/ISH classification. The presence of left ventricular hypertrophy was considered if left ventricular mass index was > or = 134 or 110 g/m(2) in men and women, respectively (Devereux criteria). A logistic regression analysis was performed to identify factors associated to left ventricular hypertrophy. RESULTS: The prevalence of left ventricular hypertrophy was 23.9% (95% CI:17.9-29.9), 25.6% in men and 22.6% in women. In the low risk group its prevalence was 20.7% and in medium risk group 29.5%. Factors associated to left ventricular hypertrophy were: years since the diagnosis of hypertension, OR:1.1 (95% CI:1.003-1.227); systolic blood pressure, OR:1.08 (95% CI:1.029-1.138); diastolic blood pressure, OR:0.9 (95% CI:0.882-0.991); and family history of cardiovascular disease, OR:4.3 (95% CI:1.52-12.18). CONCLUSIONS: These findings underline the importance of performing an echocardiogram in low and high risk untreated hypertensive patients in which treatment would otherwise be delayed for even one year.

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BACKGROUND: Microalbuminuria is an important cardiovascular risk factor, and appears to be a marker of early arterial disease in patients with and without diabetes and/or hypertension. The aim of this study was to investigate prevalence of albuminuria in hypertensive patients in clinical settings, as well as to assess the efficacy of the angiotensin receptor blocker irbesartan on the evolution of this risk marker in habitual clinical practice. METHODS: KORAL-HT is a prospective, multicenter 1-year follow-up study in inadequately controlled hypertensive patients. Demographic data, major cardiovascular risk factors, albuminuria, and clinical parameters were recorded at baseline and at 6-month and 12-month visits. During the year of follow-up, the patients received antihypertensive therapy with irbesartan in addition to their usual antihypertensive regimen. RESULTS: A total of 1657 [802 diabetics (48.4%) and 855 nondiabetics (51.6%)] hypertensive patients were studied. The prevalence of microalbuminuria in this sample was 62.5%. After 1-year treatment with irbesartan, the percentage of patients with normoalbuminuria grew from 17.1% at baseline to 40.9% at 1-year follow-up. Blood pressure (BP) decreased from 157.3 +/- 13.7/93.6 +/- 9.2 mm Hg at baseline to 139.8 +/- 13.12 mm Hg and 136.1 +/- 11.6/80.1 +/- 8 mmHg at 6- and 12-month visits, respectively. The percentage of patients who achieved BP targets increased progressively, 57.2% at 6 months, and 70.1% at the study end. CONCLUSION: This study shows that the population attending Spanish HT centers have high prevalence of microalbuminuria. The addition of irbesartan to the usual treatment in poorly controlled hypertensive patients significantly improved BP control, and reduced microalbuminuria both in diabetic and nondiabetic patients. Our study confirms that similar results can be obtained in normal clinical practice as in controlled clinical trials.

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OBJECTIVE: The present study investigated the consequences of partial AT(1) receptor blockade on the participation of catecholamines, thromboxane A(2) (TXA(2)), and endothelin-1 (ET-1) in the renal vasoconstriction induced by angiotensin II (Ang II). METHODS: For this purpose, the increase in renal perfusion pressure (RPP) produced by Ang II was studied in isolated kidneys from untreated or irbesartan-treated Wistar Kyoto and spontaneously hypertensive rats (SHR), in absence or presence of the alfa-1 receptor antagonist, prazosin, the TXA(2) receptor antagonist, ifetroban, or the ET(A)/ET(B) receptor antagonist, PD145065. RESULTS: Systolic arterial pressure (SAP) was higher (P < 0.05) in SHR than in WKY. Increases in RPP produced by Ang II were comparable in kidneys from both untreated groups. Treatment with irbesartan reduced SAP and RPP in both strains in a comparable extent. Presence of prazosin, ifetroban, or PD145065 in perfusion media reduced (P < 0.05) Ang II maximal response in all groups. Maximal inhibition of Ang II-induced vasoconstriction produced by the 3 antagonists was comparable in untreated WKY, but that of ifetroban and PD145065 was lower (P < 0.05) than that of prazosin in untreated SHR. Maximal inhibition of Ang II-induced vasoconstriction produced by the 3 antagonists was comparable in WKY treated with irbesartan, and not different to that observed in untreated WKY. Maximal inhibitory effect of the 3 antagonists was higher (P < 0.05) in treated than in untreated SHR. CONCLUSION: The study further supports the importance of catecholamines, TXA(2), and ET-1 as mediators of the renal vasoconstriction induced by Ang II in both normotensive and hypertensive rats. Hypertensive conditions appeared to reduce the participation of TXA(2) and ET-1 in Ang II-induced vasoconstriction when compared with normotensive conditions. Chronic partial blockade of AT(1) receptors did not affect the participation of catecholamines, TXA(2), and ET-1 in normotensive rats, but increased the participation of the 3 mediators in SHR. This suggests that when AT(1) receptors are partially blocked, other vasoconstrictor factors could exert part of the renal vasoconstrictor effects of Ang II.

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BACKGROUND: An important purpose of postmarketing surveillance of drugs is to better characterize the safety profile of drug therapy in the clinical setting. Another goal is to confirm the effectiveness of these drugs in patients who are candidates for antihypertensive therapy and who may have been excluded from Phase III studies. Irbesartan is a long-acting angiotensin II-receptor blocker specific for the angiotensin 1-receptor subtype that, in clinical trials in patients with hypertension, reduces blood pressure. OBJECTIVES: The KARTAN (this word was derived from the first and last syllables of Karvea [trademark of Bristol-Myers Squibb Group, Madrid, Spain] and irbesartan) study was designed to confirm and extend the findings from previous clinical trials using data from a large number of patients with hypertension treated with irbesartan in routine clinical practice. The primary goal was to assess the types and incidences of adverse drug reactions (ADRs) occurring at a low frequency (<0.05%) with irbesartan. The secondary objectives were to study the effect of irbesartan as an antihypertensive agent, to assess the types and incidences of the most frequent ADRs (>/=0.05%) occurring in routine clinical practice, and to detect possible interactions between irbesartan and other drugs frequently used in the primary care setting. METHODS: This 6-month, observational, open-label, uncontrolled, national, longitudinal, prospective study was conducted by 852 primary care physicians across Spain. Men and women aged >/=18 years with mild to moderate hypertension who, in their physicians' opinion, should have been treated with irbesartan were included. Each patient was followed up for 6 months, attending visits at baseline (ie, the start of treatment) and 1, 3, and 6 months after the start of treatment. A sample size of 3219 patients was calculated for the detection of >/=1 low-incidence (<0.05%) ADR. After the baseline visit, therapy typically was begun with irbesartan 150 mg/d. The initial dose was titrated up, at 300-mg increments based on the patient's response, at each visit as needed to achieve the treatment goals (systolic blood pressure, <140 mm Hg; diastolic blood pressure, <90 mm Hg). Information regarding ADRs was collected on case-report forms designed for each visit and analyzed by the scientific committee of the study. All recruited patients were included in the tolerability analysis. RESULTS: A total of 4887 patients were enrolled (2165 men, 2 772 women; mean [SD] age, 61.1 [11.0] years [range, 19-94 years]; 23.3% of patients were aged >70 years); 4612 were assessable for efficacy. One hundred eight patients (2.2%) experienced ADRs over the 6-month treatment period; 3 of these patients (0.1%) experienced >1 ADR. Of the total number of clinical manifestations of ADRs, 24 occurred at an incidence <0.05%. Irbesartan produced reductions in blood pressure that were statistically significant from the first visit (all p < 0.001), and 39.9% of the patients achieved the treatment goal at the end of the follow-up period. CONCLUSION: In this postmarketing surveillance study of patients with hypertension treated in routine clinical practice, irbesartan showed a satisfactory tolerability profile that was consistent with that seen in randomized, controlled trials.

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BACKGROUND AND OBJECTIVE: Our objective was to evaluate, through the health related quality of life (HRQoL) questionnaire MINICHAL, the influence of socio-demographic, clinical and therapeutic variables on health related quality of life of hypertensive patients. PATIENTS AND METHOD: An observational, prospective and multi-center study was carried out in hypertensive patients who were either starting or undergoing a modification of antihypertensive treatment. A total of three visits was done: a baseline visit and two follow-up visits at one and six months. At all three visits, several socio-demographic, clinical and therapeutic variables were recorded and HRQoL was measured using the MINICHAL questionnaire, the Spanish version of the Psychological General Well-Being Index, and a single question about the change in general health status. The objective was to evaluate the impact of these variables on HRQoL. RESULTS: 736 patients with hypertension were evaluated. In the multivariate analysis, gender, number of concomitant diseases, degree of hypertension, organ damage and educational level were all variables displaying a relation with HRQoL. After 6 months of treatment intensification, an improvement of HRQoL was observed. Moreover, a positive correlation was observed between the degree of reduction of blood pressure (BP) and heart rate and HRQoL improvement, especially in the State of mind dimension. CONCLUSIONS: In hypertension, a better BP control has a positive influence on HRQoL. As several clinical variables are negatively correlated with HRQoL, specific interventions are needed to correct modifiable factors.

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FUNDAMENTO Y OBJETIVO: Evaluar, mediante el cuestionario de calidad de vida relacionada con la salud (CVRS) MINICHAL, la influencia de las variables sociodemográficas, clínicas y terapéuticas en la calidad de vida relacionada con la salud de los pacientes hipertensos. PACIENTES Y MÉTODO: Estudio observacional, prospectivo y multicéntrico en pacientes hipertensos que iniciaban o modificaban tratamiento antihipertensivo. Se realizaron tres visitas, una basal y dos de seguimiento (una al mes y otra a los 6 meses). En ellas se registraron las variables sociodemográficas, clínicas y terapéuticas, y se aplicaron los cuestionarios validados de CVRS MINICHAL, la versión española del Índice de Bienestar Psicológico y una pregunta sobre el cambio en el estado de salud general con el objetivo de evaluar la influencia sobre la CVRS de dichas variables sociodemográficas, clínicas y terapéuticas. RESULTADOS: Se evaluó a un total de 736 pacientes hipertensos. En el análisis multivariante, el sexo femenino, el número de enfermedades concomitantes, el grado de hipertensión arterial, el grado de afección orgánica y el nivel educativo fueron las variables que se mostraron relacionadas con la CVRS. Se observó una mejoría de la CVRS tras 6 meses de intensificación del tratamiento, apreciándose una correlación positiva entre grado de reducción de presión arterial y de frecuencia cardíaca y mejora en la CVRS, especialmente en la dimensión de "Estado de ánimo". CONCLUSIONES: En los pacientes hipertensos, el mejor control de la presión arterial incide favorablemente sobre la CVRS. Además, ciertas características de los pacientes se correlacionan negativamente con la CVRS, por lo que la intervención terapéutica debe estar especialmente dirigida a corregir los factores modificables (AU)

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BACKGROUND: The finding that low health-related quality of life (HRQoL) can be a risk factor for future cardiovascular events in patients with hypertension emphasizes the need for disease-specific HRQoL assessment tools in this population. OBJECTIVE: This study evaluated the feasibility and psychometric properties of the short form of the Spanish Hypertension Quality of Life Questionnaire (MINICHAL). METHODS: An observational, prospective, multicenter study was carried out among patients with hypertension, stratified by sex and disease stage. The feasibility and validity of the MINICHAL were evaluated at baseline. Two follow-up visits were conducted at 1 and 6 months after the initial visit, during which the test-retest reliability and responsiveness to change of the MINICHAL were assessed, respectively. RESULTS: A total of 736 consecutive patients with hypertension were included. Mean (SD) administration time for the MINICHAL was 7.2 (6.5) minutes. In the validation process, factor analysis showed 2 dimensions: "State of mind" (StM) and "Somatic manifestations" (SM). The response level was high, with 94.3% of patients answering all items. Patients with a higher disease stage (ie, stage II/III hypertension) had a worse HRQoL than those with a lower disease stage (P < 0.01). Internal consistency was 0.87 for StM and 0.75 for SM. Test-retest reliability was 0.82 and 0.75 for the StM and SM dimensions, respectively. Among patients who reported experiencing a positive change in their overall health status 6 months after treatment initiation or treatment change, responsiveness to change ranged from 0.52 (better) to 1.14 (much better). CONCLUSIONS: The MINICHAL questionnaire could be administered in a short time with a high response level and was found to have acceptable psychometric properties. The MINICHAL is a potentially useful tool for the evaluation of HRQoL among patients with hypertension in the routine clinical setting.

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