Does exercise during pregnancy impact on maternal weight gain and fetal cardiac function? A Randomized controlled study.

OBJECTIVE: To evaluate the association between physical exercise during pregnancy and maternal gestational weight gain and fetal cardiac function. METHODS: This was a randomized controlled trial of women with a singleton pregnancy managed from the first trimester at the Hospital de Torrejón, Madrid, between November 2014 and June 2015. Women were randomized to either follow a supervised physical conditioning program, consisting of a 60-min session 3 days per week for the duration of pregnancy, or not attend any exercise program (controls). The primary outcome was maternal weight gain during pregnancy. Secondary outcomes included fetal cardiac function parameters evaluated at 20, 28 and 36 weeks' gestation, Cesarean section, preterm delivery, induction of labor and birth weight. A sample size of 45 in each group was planned to detect differences in maternal weight gain of at least 1 kg, with a power of > 80% and α of 0.05. RESULTS: During the study period, 120 women were randomized into the exercise (n = 75) and control (n = 45) groups. Following exclusions, the final cohort consisted of 42 women in the exercise group and 43 in the control group. Baseline characteristics (maternal age, prepregnancy body mass index, parity, conception by in-vitro fertilization, Caucasian ethnicity, physical exercise prior to pregnancy and smoker) were similar between the two groups. No differences were found between the groups in maternal weight at 20, 28, 36 and 38 weeks' gestation or in weight gain at 38 weeks. However, the proportion of women with weight loss ≥ 9 kg at 6 weeks postpartum was higher in the exercise compared with the control group (68.2% vs 42.8%; relative risk 1.593; P = 0.02). The ductus arteriosus pulsatility index (DA-PI) at 20 weeks (2.43 ± 0.40 vs 2.26 ± 0.33, P < 0.05) and the ejection fraction (EF) at 36 weeks (0.85 ± 0.13 vs 0.81 ± 0.11, P < 0.05) were higher in the exercise compared with the control group. All other evaluated fetal cardiac function parameters were similar between the two groups. CONCLUSIONS: Performing exercise during pregnancy is not associated with a reduction in maternal weight gain but increases weight loss at 6 weeks postpartum. Physical exercise during pregnancy is associated with increased fetal DA-PI at 20 weeks and EF at 36 weeks, which could reflect adaptive mechanismspre-print493 K

Predictive factors of compliance with a program of supervised exercise during pregnancy.

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Application of a new protocol for providing obstetric care in an outpatient service during the COVID-19 pandemic in a public hospital in Madrid, Spain.

Objective: To evaluate the clinical implementation of a preventive COVID-19 protocol regarding re-organization of appointments and documented infections among health workers in an obstetric outpatient service. Methods: Descriptive analysis of the antenatal care at our obstetric outpatient service and infection rates among health care providers from March 19th to May 22nd, 2020. Appointments were divided into telephone calls or face-to-face examinations. A pre-consultation triage was implemented to identify suspected SARS-CoV2 infected women to reschedule them 14 days later or, if the consultation was non-delayable, to use complete Personal Protective Equipment (PPE). Firstly, the number of face-to-face appointments, telephone appointments, and COVID-19 diagnoses in pregnant women were analyzed. Secondly, the number of obstetricians and nurses diagnosed with SARS-CoV2 infection and their serologic status during universal screening in May 2020 were recorded. Results: One thousand eight hundred forty-two obstetric appointments were scheduled during this period, including 432 (23.5%) telephone appointments (96.53% according to clinical protocol, 1.62% symptomatic patients advised to stay at home, and 1.85% COVID-19 confirmed cases), and 1,410 (76.5%) face-to-face appointments (9.7% did not attend due to fear of getting the infection, 3.1% were lost-to-follow-up, 0.5% were rescheduled due to COVID-19 symptoms and 86.7% who did attend). Of the 1,223 women attending their hospital appointment, 3.6% screened positive at the triage (72.7% rescheduled and 27.3% seen with PPE). 43 rRT-PCR-SARS-CoV2 tests were performed, and two tested positive. No COVID-19 symptoms were reported among health workers at the outpatient obstetric service, and only one nurse presented immunoglobulin (Ig)G anti-SARS-CoV2. Conclusion: A prompt implementation of a preventive protocol in a hospital obstetric outpatient service, including triage, hygienic and preventive measurements, and rescheduling pregnancy appointments, reduces the percentage of health workers affected by SARS-CoV2.post-print369 K

Maternal physiological changes at rest induced by exercise during pregnancy: A randomized controlled trial.

Objective: to analyse maternal physiological changes in several areas (cardiovascular, metabolic, renal and hepatic) related to the regular practice of a supervised exercise program. Methods: This is an unplanned secondary analysis from a randomized controlled trial carried out in a single maternity unit in Madrid, Spain (NCT 02,756,143). From November 2014 to June 2015, 92 women were randomly assigned to perform a mild-moderate supervised exercise program during pregnancy (Intervention group, IG) or to continue with their routine pregnancy care (control group, CG). For the purpose of this study we collected clinical and analytical data (heart blood pressure, weight, blood glucose, AST, ALT, blood Creatinine and blood Uric acid) available from all obstetric visits and examined the differences between groups. Results: We did not find any differences in: pregnancy weight (IG: 11.4 ± 4.4 Kg vs. CG: 10.1 ± 5.3 Kg; p = 0.173); fasting glucose at 10+0–12+6 weeks (IG: 78.48±8.34 vs. CG: 76±13.26, p = 0.305) or at 34+0–36+4 weeks (IG: 73.25±10.27 vs CG: 73.45± 8.29,p = 0.920), and 50 gs glucose tolerance at 24+4–26+6weeks (IG: 116.23±35.07 vs CG: 116.36±25.98, p = 0.984); Aspartate-amino-transferase at 10+0–12+6 weeks (IG: 15.38±4.17 vs CG: 17.33±7.05, p = 0.124) and at 34+0–36+4 weeks (IG: 21.65±5.25 vs CG: 19.53±8.32, p = 0.165) or Alanine-amino- transferase at 10+0–12+6 weeks (IG: 27.50±10.63 vs CG: 28.27±11.77, p = 0.746) or at 34+0–36+4 weeks (IG: 22.93±9.23 vs CG: 20.84±13.49, p = 0.407); blood Creatinine concentrations at 34+0–36+4 weeks (IG: 0.595±0.401 vs CG: 0.575±0.100, p = 0.757) and blood uric acid concentrations at 34+0–36+4 weeks (IG: 3.526 ± 0.787 vs CG: 3.262±0.672, p = 0.218). Heart blood pressure was similar between groups except at 27+0–28+6 weeks, where systolic blood pressure was significantly lower in the CG in comparison to the IG (116.31±10.8 mmHg vs. 120.22 ± 10.3 mmHg, p = 0.010). Conclusion: Regular supervised exercise during pregnancy does not alter normal maternal physiologypre-print609 K

Risk Factors for Preeclampsia: Results from a Cohort of Over 5000 Pregnancies in Spain.

Objective: To determine the incidence of preeclampsia (PE) and preterm PE in Spain and to identify the risk factors for developing the disease. Methods: This is a multicenter prospective cohort study performed at six maternity units across Spain. Women with singleton pregnancies attending their first-trimester routine visit at the hospital were offered participation. Maternal and pregnancy characteristics, including mean arterial pressure, as well as ultrasound findings were recorded. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for subsequent development of PE. Results:A total of 5868 pregnancies were recruited for this study, including 174 (3.0%) cases of PE, 47 (0.8%) cases of preterm PE and 127 (2.2%) cases of term PE. Median maternal age was 33.9 years (interquartile range: 30.1 to 36.9) and median gestational age at the routine visit was 12.7 weeks (interquartile range: 12.3 to 13.0). However, 293 (5.0%) of the women were on aspirin treatment during pregnancy, likely reducing the true incidence of the disease. As expected, increasing body mass index (P<0.001), uterine artery pulsatility index (P=0.011) and mean arterial pressure (P<0.001), assisted conception (P=0.013), previous personal (P<0.001) or family history of PE (P=0.024) and chronic hypertension (P=0.001) were identified as independent risk factors for developing subsequent PE during pregnancy. Screening for PE by maternal factors alone leads to a detection rate of 36.8% (64/174) at 10.0% (587/5868) screen positive rate. Conclusion: In Spain, 3.0% of singleton pregnancies are complicated by PE and 0.8% require delivery before term due to its severity. Screening of PE by risk factors alone is only able to detect about 40% of total PE at 10% screen-positive rate.post-print255 K

Clinical and Economic Evaluation after Adopting Contingent Cell-Free DNA Screening for Fetal Trisomies in South Spain.

Contingent cell-free (cf) DNA screening on the basis of the first-trimester combined test (FCT) results has emerged as a cost-effective strategy for screening of trisomy 21 (T21). Objectives: To assess performance, patients’ uptake, and cost of contingent cfDNA screening and to compare them with those of the established FCT. Methods: This is a prospective cohort study including all singleton pregnancies attending to their FCT for screening of T21 at 2 university hospitals in South Spain. When the FCT risk was ≥1:50, there were major fetal malformations, or the nuchal translucency was ≥3.5 mm, women were recommended invasive testing (IT); if the risk was between 1:50 and 1:270, women were recommended cfDNA testing; and for risks bellow 1:270, no further testing was recommended. Detection rate (DR), false-positive rate (FPR), patients’ uptake, and associated costs were evaluated. Results: We analyzed 10,541 women, including 46 T21 cases. DR of our contingent strategy was 89.1% (41/46) at 1.4% (146/10,541) FPR. Uptake of cfDNA testing was 91.2% (340/373), and overall IT rate was 2.0%. The total cost of our strategy was €1,462,895.7, similar to €1,446,525.7 had cfDNA testing not been available. Conclusions: Contingent cfDNA screening shows high DR, low IT rate, and high uptake at a similar cost than traditional screening.pre-print133 K

Informe del Comité Científico de la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN) sobre el riesgo del uso de semillas de Mucuna pruriens en productos de artesanía

El Comité Científico de la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN) ha evaluado el riesgo del uso de semillas de Mucuna pruriens en productos de artesanía. En este informe se describen sus distintos usos en dichos productos de artesanía y los usos divulgados por sus presuntas propiedades como planta medicinal, en alimentación humana, como antídoto en mordeduras de serpientes y como biomasa o cobertura vegetal. El contexto sociológico del empleo de Mucuna pruriens también se incluye en este informe. Igualmente se describen las características que identi can a Mucuna pruriens como especie vegetal, las propiedades farmacológicas y las propiedades toxicológicas descritas en estudios de toxicidad a dosis única y de toxicidad a dosis repetidas así como la evaluación del riesgo por ingesta accidental de sus semillas en productos de artesanía. Se concluye que el valor de la DL50 de Mucuna pruriens es superior a 2000 mg/kg p.c.. y se puede identi car un NOEL de 70 mg/kg p.c./dia (“dosis limite”) a partir de un estudio de toxicidad dosis repetida en conejos. Se ha estimado un valor TDLo (lowest published toxic dose, o toxic dose low) (dosis tóxica más baja publicada o dosis tóxica mínima) de L-dopa (humanos) de 4286 mg/kg p.c. El margen de seguridad calculado para la semilla de Mucuna pruriens consumida es amplio en relación con la posible exposición tanto en adultos como en niños. Sin embargo, hay que considerar también el riesgo ocasionado por la exposición accidental de las semillas de Mucuna pruriens debido a que pueden originar una oclusión respiratoria o digestiva en los niños, lo que representa un riesgo adicional. El contacto con semillas de Mucuna pruriens puede provocar prurito intenso y alergia de contacto en todos los grupos poblacionales. Los niños y mujeres gestantes presentan sensibilidad a la ingesta de semilla de Mucuna pruriens debido al contenido y acción farmacológica de la L-dopa (levodopa)

Informe del Comité Científico de la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN), sobre fotodepiladores domésticos

El Comité Científico (Sección Consumo) de la Agencia Española de Consumo, Seguridad Alimentaria y Nutrición (AECOSAN) ha elaborado este informe con el objeto de evaluar el riesgo de uso de los fotodepiladores domésticos. Este informe científico analiza los posibles efectos adversos (directos e indirectos) derivados de su uso, así como los aspectos sociológicos. El comité científico concluye, sobre la base de la información científico-técnica disponible, que no es posible analizar los aspectos de seguridad necesarios para el uso de estos dispositivos. Existe una falta de datos que procedan de estudios científico-técnicos que tengan en cuenta los posibles riesgos directos e indirectos de la exposición a corto y largo plazo de las diferentes clases/tipos de fotodepiladores domésticos, así como el potencial desarrollo de reacciones por fotosensibilidad y otros potenciales efectos adversos asociados a la exposición a sustancias volátiles, potencialmente peligrosas, que son liberadas durante la operación de eliminación del vello corporal. Este Comité considera conveniente que las autoridades competentes valoren la necesidad de que se lleven a cabo, por los responsables de su comercialización, estudios científico-técnicos que evalúen los riesgos directos e indirectos resultantes de la exposición a corto plazo y largo plazo, de las diferentes clases/tipos de fotodepiladores domésticos al objeto de poder evaluar su seguridad en el uso. Aunque existen distintos aspectos recogidos en las normas legales, reglamentarias y administrativas aplicables a estos dispositivos, el marco jurídico existente no es su ciente para garantizar la seguridad de estos dispositivos antes, durante y después del uso. A juicio de este Comité Científico, también existe una falta de legislación armonizada para todas las tecnologías implicadas en este grupo de dispositivos y sugiere revisar la regulación existente desarrollando una legislación específica para este tipo de dispositivos, especialmente los domésticos

New approach for estimating risk of miscarriage after chorionic villus sampling.

Objective To estimate the risk of miscarriage associated with chorionic villus sampling (CVS). Methods This was a retrospective cohort study of women attending for routine ultrasound examination at 11 + 0 to 13 + 6 weeks' gestation at one of eight fetal-medicine units in Spain, Belgium and Bulgaria, between July 2007 and June 2018. Two populations were included: (1) all singleton pregnancies undergoing first-trimester assessment at Hospital Clínico Universitario Virgen de la Arrixaca in Murcia, Spain, that did not have CVS (non-CVS group); and (2) all singleton pregnancies that underwent CVS following first-trimester assessment at one of the eight participating centers (CVS group). We excluded pregnancies diagnosed with genetic anomalies or major fetal defects before or after birth, those that resulted in termination and those that underwent amniocentesis later in pregnancy. We used propensity score (PS) matching analysis to estimate the association between CVS and miscarriage. We compared the risk of miscarriage of the CVS and non-CVS groups after PS matching (1:1 ratio). This procedure creates two comparable groups balancing the maternal and pregnancy characteristics that are associated with CVS, in a similar way to that in which randomization operates in a randomized clinical trial. Results The study population consisted of 22 250 pregnancies in the non-CVS group and 3613 in the CVS group. The incidence of miscarriage in the CVS group (2.1%; 77/3613) was significantly higher than that in the non-CVS group (0.9% (207/22 250); P < 0.0001). The PS algorithm matched 2122 CVS with 2122 non-CVS cases, of which 40 (1.9%) and 55 (2.6%) pregnancies in the CVS and non-CVS groups, respectively, resulted in a miscarriage (odds ratio (OR), 0.72 (95% CI, 0.48–1.10); P = 0.146). We found a significant interaction between the risk of miscarriage following CVS and the risk of aneuploidy, suggesting that the effect of CVS on the risk of miscarriage differs depending on background characteristics. Specifically, when the risk of aneuploidy is low, the risk of miscarriage after CVS increases (OR, 2.87 (95% CI, 1.13–7.30)) and when the aneuploidy risk is high, the risk of miscarriage after CVS is paradoxically reduced (OR, 0.47 (95% CI, 0.28–0.76)), presumably owing to prenatal diagnosis and termination of pregnancies with major aneuploidies that would otherwise have resulted in spontaneous miscarriage. For example, in a patient in whom the risk of aneuploidy is 1 in 1000 (0.1%), the risk of miscarriage after CVS will increase to 0.3% (0.2 percentage points higher). Conclusions The risk of miscarriage in women undergoing CVS is about 1% higher than that in women who do not have CVS, although this excess risk is not solely attributed to the invasive procedure but, to some extent, to the demographic and pregnancy characteristics of the patients. After accounting for these risk factors and confining the analysis to low-risk pregnancies, CVS seems to increase the risk of miscarriage by about three times above the patient's background risk. Although this is a substantial increase in relative terms, in pregnancies without risk factors for miscarriage, the risk of miscarriage after CVS remains low and similar to, or slightly higher than, that in the general population. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.pre-prin

Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: updated meta-analysis.

Objective: To review clinical validation or implementation studies of maternal blood cell-free (cf) DNA analysis and define the performance of screening for fetal trisomies 21, 18 and 13 and sex chromosome aneuploidies. Data sources: Searches of PubMed, Embase and the Cochrane library were performed to identify all peer-reviewed articles on cfDNA testing in screening for aneuploidies between January 2011, when the first such study was published and 31 December 2016. Results: In total, 35 relevant studies were identified and these reported cfDNA results in relation to fetal karyotype from invasive testing or clinical outcome. In the combined total of 1,963 cases of trisomy 21 and 225,032 non-trisomy 21 singleton pregnancies the pooled weighted detection rate (DR) and false positive rate (FPR) were 99.7% (95% CI 99.1-99.9%) and 0.04% (95% CI 0.02-0.08%), respectively. In a total of 560 cases of trisomy 18 and 212,019 unaffected singleton pregnancies the pooled weighted DR and FPR were 98.2% (95% CI 95.5-99.2%) and 0.05% (95% CI 0.03-0.07%). In a total of 119 cases of trisomy 13 and 212,883 unaffected singleton pregnancies the pooled weighted DR and FPR were 99.0% (95% CI 65.8-100%) and 0.04% (95% CI 0.02-0.07%). In a total of 36 cases of monosomy X and 7,677 unaffected singleton pregnancies the pooled weighted DR and FPR were 95.8% (95% CI 70.3-99.5%) and 0.14% (95% CI 0.05-0.38%). In a combined total of 17 cases of sex chromosome abnormalities other than monosomy X and 5,383 unaffected singleton pregnancies the pooled weighted DR and FPR were 100% (95% CI 83.6-100%) and 0.003% (95% CI 0-0.07%). For twin pregnancies, in a total of 24 cases of trisomy 21 and 1,111 unaffected cases the DR was 100% (95% 95.2-100%) and FPR was 0% (95% CI 0-0.003%). Conclusion: Screening by analysis of cfDNA in maternal blood in singleton pregnancies could detect >99% of fetuses with trisomy 21, 98% of trisomy 18 and 99% of trisomy 13 at a combined FPR of 0.13%. The number of reported cases of sex chromosome abnormalities is too small for accurate assessment of performance of screening. In twin pregnancies performance of screening for trisomy 21 is encouraging but the number of cases reported is small.pre-print635 K