The PREDG study: A randomised controlled trial testing whether an educational intervention can prevent gestational weight gain in women with obesity.

OBJECTIVE: The PREDG trial was designed to study the influence of an educative program on gestational weight gain in women with pregestational obesity. METHODS: Randomized controlled clinical trial (https://www.isrctn.com/ISRCTN61793947) in 169 women with pregestational obesity (BMI ≥30 kg/m2). Women were randomized to participate in a group education program in nutrition and physical activity or conventional follow-up in a specialized Unit of Obesity and Pregnancy. The nutritional intervention was adjusted to prepregnancy BMI and to the physical activity intensity. Quality was based on the Mediterranean diet. Macronutrients were distributed as follows: 50% carbohydrates, 20% protein and 30% fat. Adequate gestational weight gain was defined between 5 and 9 kg (IOM 2009). Mean gestational weight gain was compared between groups by using the T Student test and frequencies of adequate gestational weight gain were compared by using ꓫ2. RESULTS: Gestational weight gain was lower in the intervention group: 8 (4-11) vs 9.2 (6-13) kg, p 0.026. Gestational weight gain was below 9 kg in 24 of 39 (61.5%) women of the intervention vs 10 of 41 (24.4%) of the control group (p 0.001). Regarding obstetric complications, there were 15 (8.3%) cases of gestational diabetes with no differences between the groups. There were 14 of 85 (18.2%) cases of gestational hypertension or preeclampsia in the intervention group compared with 26 of 84 (32.5%) in the control group (p 0.040). With reference to neonatal weight, there were 7 of 82 (8.5%) large for gestational age neonates in the intervention group compared with 15 of 79 (19.2%) in the control group (p 0.050). CONCLUSIONS: A group-based educative and structured intervention results in an adequate weight gain and lower rates of gestational hypertension, preeclampsia and large for gestational age neonates in pregnant women with obesity.

The influence of air pollution on gestational age at delivery and birthweight in patients with or without respiratory allergy: A nested case-control study.

INTRODUCTION: Air pollution is a current major health issue. The burden of airborne pollutants and aeroallergen levels varies throughout the year, as well as their interaction and consequences. Prenatal exposure during pregnancy has been associated with adverse perinatal outcomes. The aim of this study was to evaluate the impact of air pollutants on perinatal outcomes in patients with or without respiratory allergy. MATERIAL AND METHODS: Nested case-control retrospective study on 3006 pregnant women. Correlations between concentrations of common pollutants in each trimester of pregnancy and on average during the whole pregnancy and both gestational age at delivery and birthweight were studied. Pearson's correlation coefficient and binary logistic regression were used. RESULTS: In general, pollutants correlated more strongly with birthweight than with gestational age at delivery. Nine-month NO2 , SO2 , CO, and benzene, and second-trimester CO negatively correlated with birthweight, whereas only first-trimester NO2 showed a very mild correlation with gestational age at delivery. Negative correlations between pollutants and birthweight were much stronger in the respiratory allergy group (n = 43; 1.4%) than in the non-allergic group. After adjustments, the most significant predictive pollutant of birthweight was SO2 in both groups. The best predictive model was much stronger in the allergic group for third-trimester SO2 (R2 = 0.12, p = 0.02) than in the non-allergic group for total SO2 (R2 = 0.002, p = 0.02). For each unit that SO2 increased, birthweight reduced by 3.22% vs. 1.28% in each group, respectively. CONCLUSIONS: Air pollutant concentrations, especially SO2 , negatively influenced birthweight. The impact of this association was much stronger and more relevant in the group of women with respiratory allergies.

The influence of maternal respiratory allergy on obstetrics and perinatal outcomes: A nested case-control study.

OBJECTIVE: To evaluate the influence of respiratory allergy on obstetrics and perinatal outcomes. METHODS: A nested case-control retrospective study on 41 035 pregnant women. Obstetrics and perinatal outcomes of women with or without respiratory allergy were compared. Rates of preterm delivery (<37 weeks of gestation), low birth weight (<2500 g), neonatal acidosis (pH < 7.20), low 5-min APGAR score (<7), cesarean section rate and indications, and perinatal morbidity and mortality were analyzed. Results are expressed as number and percentages. χ2 and Fisher exact tests were used for comparisons. Logistic regression was used. Statistical significance was set at 95% level (P < 0.05). RESULTS: A total of 724 (1.8%) patients had respiratory allergy, and their rates of preterm delivery and low birth weight were significantly higher than those of control women (both P < 0.001). Nevertheless, analyzing the causes, multiple gestation rate was significantly higher in this group, and adjusting by this, no statistical difference was found in any of the perinatal outcomes studied. In addition, in vitro fertilization and sterility were also significantly higher in the respiratory allergy group (both P < 0.001). CONCLUSION: Women with respiratory allergy are at higher risks of prematurity and low birth weight but these results are mediated by sterility, in vitro fertilization, and multiple gestation rate. Nonetheless, participation of inflammatory mechanisms should be further studied.

[Interarm blood pressure difference: Concordance between two methods of automatic simultaneous measurement and between visits reproducibility]. / Diferencia de presión arterial entre brazos: concordancia entre 2 métodos automáticos de medición simultánea y reproducibilidad entre visitas.

OBJECTIVE: An increased interarm blood pressure difference (IAD) (≥10mmHg) has been associated with increased cardiovascular morbidity and mortality. There are few studies determining how IAD has to be measured and its reliability between visits. The objectives of our study were twofold. First, to evaluate the concordance between two automatic oscillometric devices for IAD measurement (two OMRON devices and one Microlife WatchBP™ device (WBP™)) and to analyse the reproducibility of IAD between visits in the general population attending a primary care centre. DESIGN: Descriptive cross-sectional study of concordance between the two methods and reproducibility of IAD between two visits separated by one week. SITE: Parets del Vallès primary care centre (Barcelona). PARTICIPANTS: General population aged 35-74 years. INTERVENTIONS AND MAIN MEASUREMENTS: One hundred and forty-nine patients completed the two visits. At each visit, IAD was measured three times with both methods and the mean of the three determinations was considered. Other variables such as sociodemographic and anthropometric variables, pathological antecedents and pharmacological treatment were collected through a review of the medical history and an interview with the patient. Concordance between the two devices and between visits reproducibility were calculated using the Lin concordance coefficient (CCL) for IAD expressed continuously and kappa(k) indices for IAD categorised as normal or pathological. RESULTS: Concordance for IAD expressed continuously was low: CCL=0.13 (0.02-0.24). Concordance was also low for IAD categorised as normal or pathological (k=-0.03 (-0.05-0.00)). Reproducibility between visits was low for both methods and for both continuous and categorised IAD: with OMRON™ CCL=0.19 (0.03-0.34) and k=-0.02 (-0.16-0.12) and for WBP™ CCL=0.14 (-0.01-0.29) and k=0.49 (0.33-0.64). CONCLUSIONS: Concordance between two automatic oscillometers in the simultaneous IAD measurement was low. Reproducibility between visits was also low for both methods.

Importance of family planning in patients with immune-mediated inflammatory diseases: A multidisciplinary approach.

BACKGROUND AND OBJECTIVES: Family planning in women with immune-mediated inflammatory diseases is a challenge for healthcare teams, highlighting the need for standardized available evidence to provide patients with objective and agreed information. This study reflects the work performed by a multidisciplinary team in reviewing available scientific evidence, and the strategy agreed for family planning, pregnancy, postpartum, and breastfeeding in patients with immune-mediated inflammatory diseases. METHODS: A literature search was conducted, information was structured across the different stages (preconception, pregnancy, postpartum and breastfeeding), and an on-site meeting was convened, in which patients and healthcare providers participated. RESULTS: Specific materials, which are included in this work, were developed to guide clinical decisions to be agreed upon by patients and healthcare providers. CONCLUSION: These materials meet the need for validated and updated information on the approach and use of indicated drugs for professionals responsible for the management of immune-mediated inflammatory diseases.

Susac syndrome and pregnancy: a relationship to clarify. About two cases and review of the literature.

BACKGROUND: Susac syndrome is a vasculopathy that affects the central nervous system, mainly the brain parenchyma, retina and inner ear. It affects mainly young women and. Management is based on expert consensus and in pregnant women the treatment is not well established. It is necessary to start treatment early because of its potential severity and sequelae. METHOD: We present two cases of Susac syndrome related to pregnancy/puerperium and performed a review of the literature. CONCLUSIONS: Susac syndrome is a disease that requires a high clinical suspicion, especially in pregnant women. Treatment in pregnancy or puerperium is not well established. PRÉCIS: Susac syndrome is a disease that requires a high clinical suspicion, especially in pregnant women. Treatment in pregnancy or puerperium is not well established.

Importance of family planning in patients with immune-mediated inflammatory diseases: a multidisciplinary approach. / Importancia de la planificación familiar en pacientes con enfermedades inflamatorias inmunomediadas: un abordaje multidisciplinar.

BACKGROUND AND OBJECTIVES: Family planning in women with immune-mediated inflammatory diseases is a challenge for healthcare teams, highlighting the need for standardized available evidence to provide patients with objective and agreed information. This study reflects the work performed by a multidisciplinary team in reviewing available scientific evidence, and the strategy agreed for family planning, pregnancy, postpartum, and breastfeeding in patients with immune-mediated inflammatory diseases. METHODS: A literature search was conducted, information was structured across the different stages (preconception, pregnancy, postpartum and breastfeeding), and an on-site meeting was convened, in which patients and healthcare providers participated. RESULTS: Specific materials, which are included in this work, were developed to guide clinical decisions to be agreed upon by patients and healthcare providers. CONCLUSION: These materials meet the need for validated and updated information on the approach and use of indicated drugs for professionals responsible for the management of immune-mediated inflammatory diseases.

Pregnancy control in patients with systemic lupus erythematosus/antiphospholipid syndrome. Part 2: Pregnancy follow-up. / Control del embarazo en pacientes con lupus eritematoso sistémico/síndrome antifosfolípido. parte 2: seguimiento del embarazo.

OBJECTIVE: In order to agree on the fundamental aspects related to the management of pregnancy in patients with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS), the Spanish Societies of Gynaecology and Obstetrics, Internal Medicine and Rheumatology set up a working group for the preparation of three consensus documents. METHODS: Each of the Scientific Societies involved proposed five representatives based on their experience in the field of pregnancy control in patients with autoimmune diseases. The recommendations were developed following the Delphi methodology. RESULTS: This second document contains the recommendations regarding the management of pregnancy in women with SLE and APS, including complications such as lupus activity, congenital heart block, thrombotic and obstetric manifestations of APS and placental vascular disease. CONCLUSIONS: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with SLE/APS during pregnancy.

Pregnancy Control in Patients with Systemic Lupus Erythematosus and Antiphospholipid Syndrome. Part 1: Infertility, Ovarian Preservation and Preconception Assessment. Consensus Document of the Spanish Society of Gynaecology and Obstetrics (SEGO), the Spanish Society of Internal Medicine (SEMI) and the Spanish Society of Rheumatology (SER). / Control del embarazo en pacientes con lupus eritematoso sistémico y síndrome antifosfolípido. Parte 1: Infertilidad, preservación ovárica y valoración preconcepcional. Documento de consenso de la Sociedad Española de Ginecología y Obstetricia (SEGO), Sociedad Española de Medicina Interna (SEMI) y Sociedad Española de Reumatología (SER).

OBJECTIVE: Pregnancy and puerperium are considered a risk situation in women with systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). Therefore, specialized assessment is essential both preconception and during pregnancy and the puerperium. Likewise, it is very important that different specialists in autoimmune diseases and high-risk pregnancies participate in the follow-up of these patients in a coordinated manner. The Spanish Society of Gynaecology and Obstetrics, the Spanish Society of Internal Medicine, and the Spanish Society of Rheumatology have set up a working group for the preparation of three consensus documents. METHODS: The stages of the work were: distribution of work in three groups corresponding to the three periods related to pregnancy (preconception, during pregnancy and childbirth and puerperium), identification of key areas, exhaustive review of the literature and formulation of recommendations. RESULTS: This first document includes the 48 recommendations that address aspects related to infertility, the need for and treatments for gonadal preservation and preconception assessment. CONCLUSIONS: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with SLE/APS during pregnancy.

Pregnancy control in Patients with Systemic Lupus Erythematosus/Antiphospholipid Syndrome. Part 3: Childbirth. Puerperium. Breastfeeding Contraception. Newborn. / Control del embarazo en pacientes con lupus eritematoso sistémico/síndrome antifosfolípido. Parte 3. Parto. Puerperio. Lactancia. Anticoncepción. Recién nacido.

OBJECTIVE: In order to agree on the fundamental aspects related to the management of pregnancy in patients with systemic lupus erythematosus and antiphospholipid syndrome, the Spanish Societies of Gynaecology and Obstetrics, Internal Medicine and Rheumatology have set up a working group for the preparation of three consensus documents. METHODS: Each of the Scientific Societies involved proposed five representatives based on their experience in the field of pregnancy control in patients with autoimmune diseases. The recommendations were developed following the Delphi methodology. RESULTS: This third document contains the recommendations regarding the management of delivery, puerperium and lactation, including medication use during these periods and the care of the newborn. In addition, a section on contraception is included. CONCLUSIONS: These multidisciplinary recommendations are considered decision-making tools for clinicians involved in the care of patients with systemic lupus erythematosus/antiphospholipid syndrome during pregnancy.

Increased risk of neonatal complications or death among neonates born small for gestational age to mothers with gestational diabetes.

AIMS: To evaluate if neonatal complications or death were poorer for neonates born small for gestational age (SGA) than for those born with adequate weight or large for gestation age (LGA) to women with gestational diabetes mellitus (GDM). METHODS: Retrospective analysis of the clinical outcomes of neonates born to 3413 women with GDM. The prevalence of neonatal hypoglycaemia, hypocalcaemia, hyperbilirubinemia, polycythaemia, and death was compared among three birthweight groups: SGA, adequate, and LGA. A two-sided chi-squared or Fisher's exact test was used for between-group comparisons. A forward multiple logistic regression was performed to determine the odds ratio (OR) associated with SGA. RESULTS: Neonatal complications were more frequent in the SGA group (20.1%) than in the adequate (9.9%) or LGA (15.2%) groups. There were four deaths (1.6%) in the SGA group compared to one in the LGA (0.4%) and six in the adequate (0.2%) groups (P = 0.002). SGA was a risk factor for neonatal complications or death (OR. 2.122; 95% confidence interval, 1.552-2.899), independent of maternal age, weight gain, fasting glucose, glycaemic control, gestational hypertension, pre-eclampsia, smoking, or neonatal prematurity. CONCLUSION: SGA birthweight is an important risk factor for neonatal complications or death among neonates born to mothers with GDM.

Obstetric and perinatal outcome in anti-Ro/SSA-positive pregnant women: a prospective cohort study.

Anti-Ro/SS-A is one specific type of antinuclear antibodies. They are in the majority of cases associated with primary Sjögren syndrome (SS) but also in Systemic Lupus Erythematosus (SLE), rheumatoid arthritis (RA), and in healthy people. During pregnancy, they are mainly associated to congenital heart block (CHB) and neonatal lupus (NL). The aim of this study was to compare the rate of maternal and fetal complications between a series of anti-Ro/SS-A positive pregnant women prospectively followed. Forty-two anti-Ro/SSA antibodies positive pregnant women that were referred to our hospital between 2011 and 2015. Data about pregnancy follow-up and outcomes were prospectively recorded from electronic databases. Data included demographic characteristics of the patients and their diseases (type, treatments, profile of anti-Ro/SSA, and antiphospholipid antibodies), pregnancy complications (CHB, preeclampsia, preterm delivery), ultrasound examinations and conditions, and mode of delivery. Maternal age was 35.22 ± 3.42 years and most of them were either SLE (n = 16, 40%) or Sjögren syndrome (n = 15, 37.5%). The rest of them were asymptomatic carriers (n = 8; 20%), and there was only one case of rheumatoid arthritis (n = 1; 2.5%). The incidence of anti-Ro52 and anti-Ro60 positive was n = 13, 82.4% and n = 16, 100%, respectively. Anti-La/SSB antibodies were present in n = 17, 48,6% of the patients. Half of the patients were taking hydroxycloroquine (n = 18, 45%). Seven pregnancies were complicated by fetal anti-Ro-related cardiac disease (17.9%) including four cases (57.1%) of second-degree heart block, two cases of third degree heart block (28.6%) and one case (14.3%) of intense and diffuse hyperechogenicity in atrioventricular valves without heart block. Gestational age at diagnosis of these conditions was 23.2 ± 3.5 weeks. One of the 18 patients having hydroxychloroquine (5.6%) compared with the six of them in women not having this medication (6/22, 27.3%) (p = 0.10). Concerning about Doppler evaluation, the Z score of umbilical pulsatility index (PI) was significantly higher in the SLE patients (p = 0.02). There were no cases of preeclampsia. Labor was induced in 21 cases (52.5%) and cesarean section rate was 45%. Gestational age at birth was 39 (37-40) weeks, and the general prematurity rate was 20% (n = 8). Birthweight was 2985 g (2425-3185 g) and 2850 (12.25-52.50) centiles for gestational age. The rate of small for gestational age (SGA) infants was 31.3% for SLE patients (5/16), 13.3% for Sjögren syndrome (2/15), and 12.5% for asymptomatic women (1/8). The rate of neonatal acidosis (pH < 7.20) was 20% (8/34) and it was higher in the SLE cases (6/15, 40%) when delivered after 38 weeks. The main pregnancy complication associated to anti-Ro/SS-A antibodies is CHB. The prevalence of CHB in patients taking hydroxychloriquine is lower without distinguishing between high or low risk patients. Preterm delivery occurs in anti-Ro/SS-A patients at the same rate as in the general population if no complications such as CHB or intrauterine growth restriction (IUGR) occur. The SGA rate also is higher probably because of SLE not because anti-Ro/SS-A antibodies. Finally, the finding of high umbilical artery PI will allow to predict fetus at risk of adverse pregnancy outcomes. HIGHLIGHTS: •Anti-Ro/SS-A and anti-La/SS-B are clinically very relevant during pregnancy mainly because of their association to congenital heart block and neonatal lupus. •In our cohort, the prevalence of congenital heart block detected in patients taking hydroxycloroquine is much lower than in patients not taking it without distinguishing between high and low risk patients. •High umbilical artery pulsatility index in Doppler scans studies has been detected in our anti-Ro/SSA population (basely in SLE patients) demonstrated this measurement as a predictor of SGA and adverse pregnancy outcomes in general population such as cesarean section for fetal distress. The small for gestational age rate is higher probably because of SLE not because anti-Ro/SS-A •Preterm delivery happens in anti-Ro/SS-A patients at the same rate as in the general population if no complications such as congenital heart block or intrauterine growth restriction occur.

The effect of a triple therapy on maternal anti-Ro/SS-A levels associated to fetal cardiac manifestations.

OBJECTIVE: To evaluate the efficacy and safety of the combination of steroids, plasmapheresis and intravenous immunoglobulins (IVIG) on maternal anti Ro/SS-A antibody levels in cases of fetal cardiac involvement. MATERIAL AND METHODS: A series of three cases of positive anti-Ro/SS-A mothers with fetuses showing mild cardiac involvement were treated with a triple therapy composed of steroids, plasmapheresis and IVIG. Maternal antibody levels were measured several times before and after the application of each cycle of therapy. The effect of the treatment on fetal cardiac manifestations was also evaluated. RESULTS: Maternal anti-Ro/SS-A levels significantly decreased after each cycle of either plasmapheresis or IVIG therapy. The most significant decrease occurred after the first cycle. The natural evolution of the disease was stopped by this therapy in two of these cases, signs of cardiac inflammation decrease and none of the newborns needed neonatal pacemaker. CONCLUSIONS: A triple therapy combining plasmapheresis, IVIG and glucocorticoids may stop the natural evolution of the fetal cardiac affectation in positive anti-Ro/SS-A antibody patients. Further studies are needed in order to validate clinical applications of this treatment approach.

Prognosis of 2009 A(H1N1) influenza in hospitalized pregnant women in a context of early diagnosis and antiviral therapy.

BACKGROUND: Initial reports suggested that novel A(H1N1) influenza virus (2009 A[H1N1]v) infection was significantly more severe in pregnant than in non-pregnant women. In Spain, antiviral therapy was recommended for pregnant women from the beginning of the 2009 pandemic. METHODS: The prospective cohort study included consecutive pregnant and non-pregnant women of reproductive age with a proven diagnosis of 2009 A(H1N1)v admitted to any of the 13 participating Spanish hospitals between 12 June and 10 November 2009. RESULTS: In total, 98 pregnant and 112 non-pregnant women with proven 2009 A(H1N1)v hospitalized during the study period were included. Influenza was more severe among non-pregnant patients than pregnant patients with respect to outcomes of both intensive care unit admission (18% versus 2%; P<0.001) and death (5 versus 0; P=0.06). Pregnant women had fewer associated comorbid conditions other than pregnancy (18% versus 44%; P<0.001); they were also admitted earlier than non-pregnant women (median days since onset of symptoms: 2 versus 3; P<0.001) and a higher percentage received early antiviral therapy (41% versus 28%; P=0.03). Neither a multivariate nor a matched cohort analysis found pregnancy to be associated with greater severity than that associated with hospitalized, seriously ill non-pregnant women. CONCLUSIONS: 2009 A(H1N1)v influenza was not associated with worse outcomes in hospitalized pregnant women compared with non-pregnant ones of reproductive age in a context of early diagnosis and antiviral therapy.

Nueva terapia con inmunoglobulinas en un caso de hemocromatosis neonatal / Immunoglobulin therapy for natal hemochromatosis

La hemocromatosis neonatal es una enfermedad hepática muy severa del recién nacido y se asocia a una alta mortalidad. Se cree que su etiología es de tipo aloinmune, debido a la presencia de un anticuerpo materno hasta ahora desconocido que interfiere con el metabolismo férrico del feto, llegando a producir gran morb i mortal ¡dad. Basándonos en esta teoría, el tratamiento materno con inmunoglobulinas intravenosas en gestaciones sucesivas podría prevenir el desarrollo de un nuevo cuadro de hemocromatosis neonatal. Se describe el caso de una gestante con un hijo anterior diagnosticado y fallecido neonatalmente por hemocromatosis, a la que en el embarazo actual se le trató con inmunoglobulinas intravenosas consiguiendo un hijo sano y vivo. Es el primer caso descrito en España y demuestra el éxito de esta terapia, tal como describe la literatura.

Neonatal hemochromatosis is a severe neonatal liver disease with a high mortality and recurrence rate. It is supposed to be a gestational alloimmune disease because of the existence of maternal antibodies against fetal hepatic metabolism. On the basis of this hypothesis, the administration of intravenous immunoglobulin has been reported as a successful treatment during the following pregnancy. We describe the first case of this treatment in Spain which confirms the data available in the literature.