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Objective The primary aim of this article was to describe SARS‐CoV‐2 infection among pregnant women during the wild‐type and Alpha‐variant periods in Italy. The secondary aim was to compare the impact of the virus variants on the severity of maternal and perinatal outcomes. Design National population‐based prospective cohort study. Setting A total of 315 Italian maternity hospitals. Sample A cohort of 3306 women with SARS‐CoV‐2 infection confirmed within 7 days of hospital admission. Methods Cases were prospectively reported by trained clinicians for each participating maternity unit. Data were described by univariate and multivariate analyses. Main outcome measures COVID‐19 pneumonia, ventilatory support, intensive care unit (ICU) admission, mode of delivery, preterm birth, stillbirth, and maternal and neonatal mortality. Results We found that 64.3% of the cohort was asymptomatic, 12.8% developed COVID‐19 pneumonia and 3.3% required ventilatory support and/or ICU admission. Maternal age of 30–34 years (OR 1.43, 95% CI 1.09–1.87) and ≥35 years (OR 1.62, 95% CI 1.23–2.13), citizenship of countries with high migration pressure (OR 1.75, 95% CI 1.36–2.25), previous comorbidities (OR 1.49, 95% CI 1.13–1.98) and obesity (OR 1.72, 95% CI 1.29–2.27) were all associated with a higher occurrence of pneumonia. The preterm birth rate was 11.1%. In comparison with the pre‐pandemic period, stillbirths and maternal and neonatal deaths remained stable. The need for ventilatory support and/or ICU admission among women with pneumonia increased during the Alpha‐variant period compared with the wild‐type period (OR 3.24, 95% CI 1.99–5.28). Conclusions Our results are consistent with a low risk of severe COVID‐19 disease among pregnant women and with rare adverse perinatal outcomes. During the Alpha‐variant period there was a significant increase of severe COVID‐19 illness. Further research is needed to describe the impact of different SARS‐CoV‐2 viral strains on maternal and perinatal outcomes., Tweetable abstract The rate of severe COVID‐19 disease increased during the Alpha‐variant period compared with the wild‐type period.

This study had two aims: (1) to explore the types and incidence of obstetric violence (OV) in a group of Italian women, as well as associated socio-demographic factors; and (2) to assess whether OV affects women’s mental health (e.g. psychological distress and post-traumatic stress). A web-based cross-sectional study was conducted with 282 Italian women. Women answered questions on socio-demographic factors, childbirth characteristics, OV and mental health. Multiple linear regression analyses assessing the predictive role of socio-demographic and childbirth characteristics on OV were conducted. Additionally, hierarchical multiple linear regression analyses assessing whether OV affected women’s mental health were also carried out. More than three quarters of the sample (78.4%) had experienced at least one type of OV (55.5% of non-consented care and 66.4% of abuse and violence). The factors most associated with OV were younger age, low educational level, not having attended a prenatal childbirth preparedness course, and having given birth naturally. The form of OV that most affected women’s mental health was that linked to abuse and violence rather than non-consented care. Study findings shed light into addressing OV from a multidimensional perspective.

Background The COronaVIrus Disease 2019 (COVID-19) has spread in Italy since February 2020, inducing the government to call for lockdown of any activity, apart primary needs, during the months March–May 2020. During the lockdown, a reduction of admissions and hospitalizations for ischemic diseases was noticed. Purpose of this study was to observe if there has been the same reduction trend in Accident & Emergency (A&E) unit admissions also for obstetric-gynecological conditions. Methods Medical records and electronic clinical databases were searched for all patients who were admitted to the obstetric A&E department or hospitalized at the Gynecology and Obstetrics Unit of University hospital of Naples Federico II, during the quarter March–May in the years 2019 and 2020. The mean ± standard deviation (SD) of monthly admission to the obstetric A&E department and hospitalization of the year 2020 was compared with that of the year 2019, using the unpaired T test with α error set to 0.05 and 95% confidence intervals (95% CI). Results Admissions were 1483 in the year 2020 and 1786 in 2019. Of total, 1225 (37.5%) women were hospitalized: 583 in the year 2020, 642 in 2019. Mean ± SD of patients monthly admitted to our obstetric A&E department was 494 ± 33.7 in the year 2020, and 595.3 ± 30.9 in 2019, with a mean difference of − 101.3 (95% CI − 103.5 to − 99.1; p p Conclusion A significant decrease in the mean of monthly admissions and hospitalizations during the COVID-19 pandemic when compared to the previous year was found also for obstetric–gynecological conditions. Further studies are necessary to assess COVID-19 impact and to take the most appropriate countermeasures.

Background: Poly (ADP-ribose) polymerase-inhibitors (PARPis) showed antitumour activity in BRCA1/2-mutated cancers, with more heterogeneous outcomes in tumours harbouring mutations that impair other genes involved in the DNA homologous recombination repair (HRR) or wild-type (wt). Methods: We conducted a systematic review and meta-analysis to better assess the role of PARPis in the treatment of metastatic solid tumours, with and without BRCA1/2 mutations. The primary end-point was progression-free survival (PFS). The secondary end-points were overall response rate (ORR) and overall survival (OS). A random-effects model was applied. Results: Twenty-nine studies (8,839 patients) were included. PFS was significantly improved (hazard ratio [HR]: 0.59, 95% confidence interval [CI]: 0.51-0.68, p < 0.001), without being affected by BRCA mutational status (p = 0.65). Significant subgroup differences were observed with regard to the tumour site (p = 0.001), line of therapy (p = 0.002), control arm (p < 0.001), type of PARPi (p < 0.001) and trials' phase (p = 0.006). PARPis were associated with ORR (relative risk: 1.35, 95% CI: 1.16-1.56, p < 0.001), with significant subgroup differences observed with regard to treatment line (p = 0.03), control arm (p = 0.04) and PARPis (p < 0.001) and independent of mutational status (p = 0.44), tumour site (p = 0.86) and trials' phase (p = 0.09). OS was significantly improved by PARPis (HR: 0.86, 95% CI: 0.80-0.92, p < 0.001), regardless of mutational status (p = 0.57), tumour site (p = 0.82), treatment line (p = 0.22), control arm (p = 0.21), PARPis (p = 0.30) and trials' phase (p = 0.26). Finally, an exploratory subgroup analysis showed a significant PFS improvement (HR: 0.51, 95% CI: 0.43-0.60, p < 0.001) with PARPis in BRCA-wt/HRR-deficient tumours. Conclusion: Our results confirm the efficacy of already approved PARPi-based treatments in BRCA1/2-mutant solid tumours, support their role also in BRCA-independent HRR-deficient tumours and suggest a potentially broader efficacy in some wt tumours, perhaps with appropriate therapeutic partners. Prospective studies are warranted.

Perineal trauma after vaginal delivery is common and is associated with severe morbidity, including incontinence, pelvic pain, and sexual dysfunction. Morbidity is mainly related to third- or fourthdegree lacerations.This study aimed to test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery could reduce the rate of perineal laceration.This was a parallel-group, nonblinded, randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted to the labor and delivery room between 37 0/7 and 42 0/7 weeks of gestation were eligible, and were randomized in a 1:1 ratio to receive hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor. The primary outcome was perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as relative risk with 95% confidence interval.A total of 70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15 of 35 (42.9%) women in the intervention group and 33 of 35 (94.3%) women in the control group (relative risk, 0.45; 95% confidence interval, 0.31-0.67). Hands-off technique was also associated with significantly decreased incidence of episiotomy (relative risk, 0.36; 95% confidence interval, 0.14-0.88), first-degree lacerations (relative risk, 0.41; 95% confidence interval, 0.20-0.87), and second-degree lacerations (relative risk, 0.43; 95% confidence interval, 0.19-0.99). There was no significant between-group difference in third- and fourth-degree lacerations, but the trial was not powered for these outcomes.In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations.

A 1-year pilot cross-sectional study was performed to assess eating behaviours and lifestyle among Chinese and Arab pregnant immigrants to Italy. A number of 95 Chinese and 83 Arab women were interviewed. Two ethnic-specific food frequency questionnaires were designed to reflect the habitual diet of women belonging to these ethnic groups. Food items frequency of consumption was discussed using healthy eating guidelines. In both populations, women met healthy eating guidelines, except for salt intake, which was double than recommended; meat, sweet products and sugar-sweetened beverages were consumed more frequently than recommended, while olive oil and yogurt were eaten less frequently. Chinese women did not reach the recommendations for dairy products and fatty fish and exceeded those for red and processed meat, whereas Arab women exceeded the recommendations for cheese. Our findings suggest that the Italian food environment did not significantly affect Chinese and Arab pregnant immigrants' diet.

Randomized trials have found benefits of both vaginal progesterone and 17-alpha-hydroxyprogesterone caproate in the prevention of recurrent preterm birth. A previous meta-analysis directly comparing the two was limited by low-quality evidence, and national and international society guidelines remain conflicting regarding progestin formulation recommended for prevention of recurrent preterm birth. The aim of this updated systematic review with meta-analysis was to evaluate the efficacy of vaginal progesterone compared with 17-alpha-hydroxyprogesterone caproate in the prevention of spontaneous preterm birth in patients with singleton gestations and previous spontaneous preterm birth.Searches were performed in MEDLINE, Ovid, Scopus, ClinicalTrials.gov, the International Prospective Register of Systematic Reviews (PROSPERO), SciELO, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) with the use of a combination of keywords and text words related to "preterm birth," "preterm delivery," "singleton," "cervical length," "progesterone," "progestogens," "vaginal," "17-alpha-hydroxy-progesterone caproate," and "intramuscular" from inception of each database to September 2021. No restrictions for language or geographic location were applied.We included all randomized controlled trials of asymptomatic singleton gestations with previous spontaneous preterm birth that were randomized to prophylactic treatment with either vaginal progesterone (ie, intervention group) or intramuscular 17-alpha-hydroxyprogesterone caproate (ie, comparison group). Post hoc sensitivity analysis was performed for studies with low risk of bias and studies with protocol registration.The primary outcome was preterm birth34 weeks' gestation. The summary measures were reported as relative risks with 95% confidence intervals.Seven randomized controlled trials including 1910 patients were included in the meta-analysis. Patients who received vaginal progesterone had a significantly lower rate of preterm birth at34 weeks (14.7% vs 19.9%; relative risk, 0.74; 95% confidence interval, 0.57-0.96), preterm birth at37 weeks (36.0% vs 46.6%; relative risk, 0.76; 95% confidence interval, 0.69-0.85), and preterm birth at32 weeks of gestation (7.9% vs 13.6%; relative risk, 0.58; 95% confidence interval, 0.39-0.86), compared with women who received intramuscular 17-alpha-hydroxyprogesterone caproate. There were no significant differences in the rate of preterm birth at28 weeks' gestation. Adverse drug reactions were significantly lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (15.6% vs 22.2%; relative risk, 0.71; 95% confidence interval, 0.54-0.92). Perinatal mortality was lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (2.2% vs 4.4%; relative risk, 0.51; 95% confidence interval, 0.25-1.01). In sensitivity analysis including trials rated with at least 4 Cochrane tools as of "low risk of bias," 4 trials were included (N=575), and there was no longer a significant difference in preterm birth at34 weeks' gestation between vaginal progesterone and 17-alpha-hydroxyprogesterone caproate (12.2% vs 13.9%; relative risk, 0.87; 95% confidence interval, 0.57-1.32).Overall, vaginal progesterone was superior to 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth at34 weeks' gestation in singleton pregnancies with previous spontaneous preterm birth. Although sensitivity analysis of high-fidelity studies showed the same trend, findings were no longer statistically significant.

Anthracyclines are among the most active chemotherapies (CT) in breast cancer (BC). However, cardiotoxicity is a risk and peculiar side effect that has been limiting their use in clinical practice, especially after the introduction of taxanes. Non‐pegylated liposomal doxorubicin (NPLD) has been developed to optimize the toxicity profile induced by anthracyclines, while maintaining its unquestionable therapeutic index, thanks to its delivering characteristics that increase its diffusion in tumor tissues and reduce it in normal tissues. This feature allows NPLD to be safely administered beyond the standard doxorubicin maximum cumulative dose of 450–480 mg/m2. Following three pivotal first‐line phase III trials in HER2‐negative metastatic BC (MBC), this drug was finally approved in combination with cyclophosphamide in this specific setting. Given the increasing complexity of the therapeutic scenario of HER2‐negative MBC, we have carefully revised the most updated literature on the topic and dissected the potential role of NPLD in the evolving therapeutic algorithms., SCOPUS: re.j, info:eu-repo/semantics/published

Objective: To evaluate use of vaginal lactoferrin in prevention of preterm birth (PTB) in women with first trimester bacterial vaginosis and prior spontaneous PTB.Methods: This is a retrospective cohort study of all consecutive singleton gestations with prior PTB, and first trimester diagnosis of bacterial vaginosis. Women who were found to have bacterial vaginosis were recommended lactoferrin 300 mg vaginal tablets daily for 21 days. The primary outcome was the incidence of PTB at less than 37 weeks of gestations. Outcomes were compared in women who received daily lactoferrin with those who did notResults: During the study period, 847 pregnant women with prior spontaneous PTB were screened for bacterial vaginosis. Of them, 193 were found to have bacterial vaginosis in the first trimester, with an overall incidence of 22.8%. Out of the 193 women, 125 met the inclusion criteria for the study and were analyzed. Sixty of the included women received vaginal lactoferrin, while 65 did not. Women who received supplementation with lactoferrin had a significantly lower rate of PTB

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6±9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8–0.9 per week increase; p Conclusions Early gestational age at infection, maternal ventilatory supports and low birthweight are the main determinants of adverse perinatal outcomes in fetuses with maternal COVID-19 infection. Conversely, the risk of vertical transmission seems negligible.

Background The current standard first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive (+) metastatic breast cancer is the combination of pertuzumab, trastuzumab and a taxane (P + T + taxane), while standard second-line is ado-trastuzumab-emtansine (T-DM1). The registration trial of pertuzumab, however, did not include early-relapsing patients, defined as patients experiencing tumor relapse ≤12 months from the end of (neo)adjuvant anti-HER2 therapy. Conversely, the pivotal trial of T-DM1 included some patients relapsing ≤6 months after the end of (neo)adjuvant trastuzumab. Thus, a proportion of early-relapsing patients are currently eligible to receive T-DM1 as first-line treatment. Nevertheless, no direct comparison exists between the two regimens in this clinical setting. Patients and methods We retrospectively compared T-DM1 versus P + T + taxane as first-line treatment in two cohorts of early-relapsing patients in an Italian ‘real-world’ setting, involving 14 public health care institutions. The primary endpoint was progression-free survival. Secondary endpoints included patients' characterization, overall survival and post-progression survival. Univariate and multivariate analyses were carried out. All tests were two-sided and a P ≤ 0.05 was considered statistically significant. Results Among 1252 screened patients, 75 met the inclusion criteria. Forty-four (58.7%) received P + T + taxane and 31 (41.3%) received T-DM1. The two cohorts showed similar characteristics of aggressiveness and no significant differences in treatment history. T-DM1, compared with P + T + taxane was associated with worse progression-free survival (adjusted hazard ratio: 2.26, 95% confidence interval: 1.13-4.52, P = 0.021) and overall survival (adjusted hazard ratio: 3.95, 95% confidence interval: 1.38-11.32, P = 0.010), irrespective of previous (neo)adjuvant treatment, age, hormone receptors status, time-to-relapse (≤6 months or within 6-12 months) and presence of visceral/brain metastases. No differences were observed in post-progression survival (P = 0.095). Conclusions Our study suggests superiority for P + T + taxane over T-DM1 as up-front treatment of early-relapsing HER2+ metastatic breast cancer, which merits further assessment in larger and prospective trials., Highlights • This is the first study comparing pertuzumab + trastuzumab + taxane (P + T + taxane) with T-DM1 in early-relapsing HER2+ MBC. • The majority of early-relapsing HER2+ MBC have high-grade, node-positive, large primary tumors. • First-line T-DM1 compared with P + T + taxane is associated with worse progression-free survival. • First-line T-DM1 compared with P + T + taxane is associated with worse overall survival. • Post-progression survival does not differ between the two treatments cohorts.

WOS:000613461600006 PubMed ID: 32926494 Objectives To evaluate the maternal and perinatal outcomes of pregnancies affected by SARS-CoV-2 infection. Methods This was a multinational retrospective cohort study including women with a singleton pregnancy and laboratory-confirmed SARS-CoV-2 infection, conducted in 72 centers in 22 different countries in Europe, the USA, South America, Asia and Australia, between 1 February 2020 and 30 April 2020. Confirmed SARS-CoV-2 infection was defined as a positive result on real-time reverse-transcription polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens. The primary outcome was a composite measure of maternal mortality and morbidity, including admission to the intensive care unit (ICU), use of mechanical ventilation and death. Results In total, 388 women with a singleton pregnancy tested positive for SARS-CoV-2 on RT-PCR of a nasopharyngeal swab and were included in the study. Composite adverse maternal outcome was observed in 47/388 (12.1%) women; 43 (11.1%) women were admitted to the ICU, 36 (9.3%) required mechanical ventilation and three (0.8%) died. Of the 388 women included in the study, 122 (31.4%) were still pregnant at the time of data analysis. Among the other 266 women, six (19.4% of the 31 women with first-trimester infection) had miscarriage, three (1.1%) had termination of pregnancy, six (2.3%) had stillbirth and 251 (94.4%) delivered a liveborn infant. The rate of preterm birth before 37 weeks' gestation was 26.3% (70/266). Of the 251 liveborn infants, 69/251(27.5%) were admitted to the neonatal ICU, and there were five (2.0%) neonatal deaths. The overall rate of perinatal death was 4.1% (11/266). Only one (1/251, 0.4%) infant, born to a mother who tested positive during the third trimester, was found to be positive for SARS-CoV-2 on RT-PCR. Conclusions SARS-CoV-2 infection in pregnant women is associated with a 0.8% rate of maternal mortality, but an 11.1% rate of admission to the ICU. The risk of vertical transmission seems to be negligible. (C) 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Simple Summary Hormone receptor-positive (HR+)/HER2-negative is the most frequent subgroup of metastatic breast cancer (MBC). Important therapeutic advances in the treatment of this tumor type have been observed in the last 20 years, with the approval of numerous endocrine therapies (ET) with or without target therapies (TT). To improve our current knowledge and support clinical decision-making, we conducted a systematic literature and meta-analysis focused on the most relevant/promising first-/second-line ET ± TT of the last 20 years. We observed that CDK4/6-inhibitors(i) + ET were the most effective regimens. At the same time, mTORi-based combinations proved to be a valid therapeutic option in endocrine-resistant tumors, as well as PI3Ki + ET in PIK3CA-mutant patients. Single agent ET might still be a valuable upfront treatment in endocrine sensitive and non-visceral disease. Abstract A precise assessment of the efficacy of first-/second-line endocrine therapies (ET) ± target therapies (TT) in clinically-relevant subgroups of hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) has not yet been conducted. To improve our current knowledge and support clinical decision-making, we thus conducted a systematic literature search to identify all first-/second-line phase II/III randomized clinical trials (RCT) of currently approved or most promising ET ± TT. Then, we performed a meta-analysis to assess progression-free (PFS) and/or overall survival (OS) benefit in several clinically-relevant prespecified subgroups. Thirty-five RCT were included (17,595 patients). Pooled results show significant reductions in the risk of relapse or death of 26–41% and 12–27%, respectively, depending on the clinical subgroup. Combination strategies proved to be more effective than single-agent ET (PFS hazard ratio (HR) range for combinations: 0.60–0.65 vs. HR range for single agent ET: 0.59–1.37; OS HR range for combinations: 0.74–0.87 vs. HR range for single agent ET: 0.68–0.98), with CDK4/6-inhibitors(i) + ET being the most effective regimen. Single agent ET showed comparable efficacy with ET+TT combinations in non-visceral (p = 0.63) and endocrine sensitive disease (p = 0.79), while mTORi-based combinations proved to be a valid therapeutic option in endocrine-resistant tumors, as well as PI3Ki + ET in PIK3CA-mutant tumors. These results strengthen international treatment guidelines and can aid therapeutic decision-making.

Càncer de mama; Genòmica del càncer; Recerca translacional Cáncer de mama; Genómica del cáncer; Investigación traslacional Breast cancer; Cancer genomics; Translational research Novel antibody-drug conjugates against HER2 are showing high activity in HER2-negative breast cancer (BC) with low HER2 expression (i.e., 1+ or 2+ and lack of ERBB2 amplification). However, the clinical and molecular features of HER2-low BC are yet to be elucidated. Here, we collected retrospective clinicopathological and PAM50 data from 3,689 patients with HER2-negative disease and made the following observations. First, the proportion of HER2-low was higher in HR-positive disease (65.4%) than triple-negative BC (TNBC, 36.6%). Second, within HR-positive disease, ERBB2 and luminal-related genes were more expressed in HER2-low than HER2 0. In contrast, no gene was found differentially expressed in TNBC according to HER2 expression. Third, within HER2-low, ERBB2 levels were higher in HR-positive disease than TNBC. Fourth, HER2-low was not associated with overall survival in HR-positive disease and TNBC. Finally, the reproducibility of HER2-low among pathologists was suboptimal. This study emphasizes the large biological heterogeneity of HER2-low BC, and the need to implement reproducible and sensitive assays to measure low HER2 expression. This work was supported by the grants from the European Union’s Horizon 2020 Research and Innovation Programme under Grant agreement No. 847912 (to A.P.), the Instituto de Salud Carlos III-PI16/00904 (to A.P.), Pas a Pas (to A.P.), Save the Mama (to A.P.), Breast Cancer Now-2018NOVPCC1294 (to A.P.), Fundación Científica Asociación Española Contra el Cáncer-Ayuda Postdoctoral AECC 2017 (to F.B.-M.), Fundación SEOM, Becas FSEOM para Formación en Investigación en Centros de Referencia en el Extranjero 2018 (to T.P.) and PhD4MD - Departament de Salut expedient SLT008/18/00122 (to N.C.).

Fractional COA single-center observational prospective cohort study was performed enrolling all GSM patients from July 2017 to October 2018. Patients underwent three outpatient vulvovaginal applications of fractional COOf 20 enrolled patients, 18 underwent all laser applications, and 15 underwent both vulvar biopsies. 93.3% of patients showed remodeling of vulvar connective tissue; 80% showed improvement in vulvar epithelium trophism and 86.7% showed neovascularization. Differences in means between before and after treatment were significant for VuHI, VHI, and all GSM symptoms. Means ± standard deviation of the degree of pain at each laser application were 4.4 ± 0.9, 3.7 ± 1.6, and 2.9 ± 1.9. The rate of overall satisfaction with the treatment was 72.2%.Fractional CO

Objectives To describe a cohort of Italian women with confirmed COVID-19 infection admitted during pregnancy for out or inpatient hospital care, in order to provide rapid feedback for clinicians and policymakers. Design National population-based cohort study. Setting 297 Italian public and private maternity units. Population Pregnant women with COVID-19 infection confirmed by RT-PCR testing through nasopharyngeal swab and/or chest RX or CT findings and/or antibody response from maternal blood. Exclusion criteria: age

Objective: To compare women's experience of first-trimester combined screening (FTCS), with women's experience of an approach that uses the combination of a detailed early anatomy scan and cell-free DNA (cfDNA) analysis. Methods: This was single-center, open label, parallel group, randomized clinical trial. Pregnant women were randomized at the time of their first prenatal visit to either a policy of first-trimester risk assessment based on FTCS, or to a policy of first-trimester risk assessment based on ultrasound findings and cfDNA. Control group included first-trimester risk assessment based on FTCS. FTCS included ultrasound evaluation with crown-rump length, nuchal translucency (NT) measurement, and a detailed ultrasound scan, along with biochemistry (PAPP-A and free beta hCG). In this group, diagnostic testing was offered to patients with risk >1 in 100, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Women randomized in the intervention group received an approach of first-trimester risk assessment based on ultrasound findings and cfDNA. cfDNA analysis included a simultaneous microarray-based assay of non-polymorphic (chromosomes 13, 18, 21, X and Y) and polymorphic loci to estimate chromosome proportion and fetal fraction. In the intervention group, diagnostic testing was offered to patients with abnormal cfDNA screening results, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Participants received pre-test and post-test questionnaires regarding to measure reassurance, satisfaction, and anxiety. The primary outcome was the post-test reassurance, defined as mean score of reassurance post-test questionnaire. The effect of the assigned screening test on the cumulative incidence or on the mean of each outcome was quantified as the relative risk (RR) or mean difference (MD) with 95% confidence interval (CI). Results: 40 women with singleton gestations were included in the trial. Mean score for reassurance was significantly higher in the cfDNA group compared to the FTCS group in the pre-test questionnaire (MD 0.80 points, 95% CI 0.27 to 1.33) and in the post-test questionnaire (MD 16.50 points, 95% CI 2.18 to 30.82). Women randomized to the cfDNA group had higher satisfication and lower mean anxiety score as assessed in the STAI pre-test questionnaire. Conclusions: First-trimester risk assessment for trisomy 21 with a combination of a detailed ultrasound examination and cfDNA is associated with better maternal reassurance and better maternal satisfaction compared to the standard first-trimester combined screening with nuchal trasclucency, and maternal serum free beta-human chorionic gonadotrophin (FbetahCG) and pregnancy-associated plasma protein A (PAPP-A). This article is protected by copyright. All rights reserved.

Objective: E-Cervix™ (WS80A; Samsung, Seoul, Korea) elastography is a recent quantification tool to measure the stiffness of the cervix using strain elastography. The aim of this study was to evaluate the prediction performance of E-cervix for preterm birth in singleton gestation with threatened preterm labor (PTL). Methods: This was a cohort study of singleton pregnancies without prior preterm birth presenting to obstetrics triage for threatened PTL between 23 0/7 and 33 6/7 week who received screening for PTL with transvaginal ultrasound cervical length (TVU CL) and cervical elastography with E-cervix at the time of triage. Cervical elastography parameters were examined and compared between women who delivered preterm and those who did not. The quantification of cervical strain was calculated by a data analysis system that directly analyses raw data from the region of interest (ROI) and described as hardness ratio (HR), mean strain level within 1 cm from internal os (IOS) and external os (EOS). Results: Ninety-five singleton pregnancies without prior preterm birth and with threatened PTL between 23 0/7 and 33 6/7 week of gestation were included in the study. Forty-two (44.2%) had cervical length

Background: HER2-positive (HER2+) breast cancer (BC) comprises all the four PAM50 molecular subtypes. Among these, the HER2-Enriched (HER2-E) appear to be associated with higher pathological complete response (pCR) rates following anti-HER2-based regimens. Here, we present a meta-analysis to validate the association of the HER2-E subtype with pCR following anti-HER2-based neoadjuvant treatments with or without chemotherapy (CT). Methods: A systematic literature search was performed in February 2019. The primary objective was to compare the association between HER2-E subtype (versus others) and pCR. Selected secondary objectives were to compare the association between 1) HER2-E subtype and pCR in CT-free studies, 2) HER2-E subtype within hormone receptor (HR)-negative and HR+ disease and 3) HR-negative disease (versus HR+) and pCR in all patients and within HER2-E subtype. A random-effect model was applied. The Higgins��� I2 was used to quantify heterogeneity. Results: Sixteen studies were included, 5 of which tested CT-free regimens. HER2-E subtype was significantly associated with pCR in all patients (odds ratio [OR] = 3.50, p < 0.001, I2 = 33%), in HR+ (OR = 3.61, p < 0.001, I2 = 1%) and HR-negative tumors (OR = 2.28, p = 0.01, I2 = 47%). In CT-free studies, HER2-E subtype was associated with pCR in all patients (OR = 5.52, p < 0.001, I2 = 0%) and in HR + disease (OR = 4.08, p = 0.001, I2 = 0%). HR-negative status was significantly associated with pCR compared to HR + status in all patients (OR = 2.41, p < 0.001, I2 = 30%) and within the HER2-E subtype (OR = 1.76, p < 0.001, I2 = 0%). Conclusions: The HER2-E biomarker identifies patients with a higher likelihood of achieving a pCR following neoadjuvant anti-HER2-based therapy beyond HR status and CT use. Future trial designs to escalate or de-escalate systemic therapy in HER2+ disease should consider this genomic biomarker.

Background: Gallbladder duplication is a rare anatomic anomaly characterized by the presence of an accessory gallbladder. Objective: To appraise the prevalence and significance of prenatal diagnosis of duplication of gallbladder in a multicenter study. Methods: This was a multicenter case series with literature review. Clinical records of all consecutive pregnant women with a prenatal diagnosis of duplication of gallbladder, who were referred to our Centers were included in this study. The diagnosis of duplication of gallbladder was based on the evidence of double gallbladder in the standard abdominal circumference plane using grey scale. Postnatal magnetic resonance cholangiopancreatography (MRCP) 3D and postnatal neonatal abdominal ultrasound scan were offered soon after birth to confirm the diagnosis of double gallbladder. The systematic review was conducted using electronic databases from inception of each database through December 2019. Results: Five studies, including a total of seven cases, were identified as relevant and included in the systematic review. Gestational age at diagnosis ranged from 20 to 32 weeks of gestation. Associated findings were reported in only one case, where the fetus presented with a left-sided gallbladder, and bilateral renal agenesis with Potter sequence. None of the included cases reported abnormal karyotype. Our cases series included nine cases (0.03%) of double gallbladder with postnatal confirmation, with an overall incidence of this anomaly of 0.03%.Associated findings were reported in only two cases, one with IUGR and omphalocele, that opted for I-TOP, and one with single umbilical artery. Except for the I-TOP, neonatal outcome was favorable in all cases. Conclusions: Duplication of the gallbladder is a very rare malformation with only seven cases reported in the literature diagnosed prenatally. This anomaly is not associated with abnormal karyotype, and the neonatal outcome is favorable if there are no other associated abnormalities.

Background: Women’s experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions. Objective: To test the hypothesis that in nulliparous women with singleton pregnancies at term, listening to music would reduce the pain level during labor. Methods: Parallel group non-blinded randomized clinical trial conducted at a single center in Italy. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 and 42 0/7 weeks of gestation for active phase of labor were eligible, and were randomized in a 1:1 ratio to receive music during labor or no music during labor. Music in labor was defined listening to music from the randomization until the delivery of the baby. The primary endpoint was the pain level during the active phase of labor, recorded using the visual analogue scale (VAS) for pain, ranging from 0 (no pain) to 10 (unbearable pain). The effect of music use during labor on each outcome was quantified as the mean difference (MD) with 95% confidence interval (CI). Results: During the study period, 30 women agree to take part in the study, underwent randomization, and were enrolled and followed up. 15 women were randomized in the music group, and 15 in the control group. No patients were lost to follow up for the primary outcome. Pain level during the active phase of labor was scored 8.8 ± 0.9 in the music group, and 9.8 ± 0.3 in the control group (MD − 1.00 point, 95% CI − 1.48 to − 0.52; P < 0.01). Music during labor and delivery was also associated with a decreased pain at 1 h postpartum (MD − 2.40 points, 95% CI − 4.30 to − 0.50), and decreased anxiety level during active phase of labor (MD − 19.90 points, 95% CI − 38.72 to − 1.08), second stage of labor (MD − 49.40 points, 95% CI − 69.44 to − 29.36), and at 1 h postpartum (MD − 27.00 points, 95% CI − 47.37 to − 6.63). Conclusion: In nulliparous women with singleton pregnancies at term, listening to music reduces the pain level, and the anxiety level during labor. Trial registration: Clinicaltrials.gov NCT03779386.

Background: Postpartum hemorrhage (PPH) is responsible for about 25% of maternal deaths worldwide. Antifibrinolytic agents, mainly tranexamic acid (TXA), have been demonstrated to reduce blood loss in patients with established PPH. Objective: The aim of this meta-analysis of randomized controlled trials (RCTs) was to evaluate the effectiveness of TXA administration in women with established primary PPH after vaginal delivery. Data sources: The search was conducted using electronic databases from inception of each database through February 2018. Review of articles also included the abstracts of all references retrieved from the search. No restrictions for language or geographic location were applied. Study design: Selection criteria included RCTs comparing the use of TXA in women with established primary PPH after vaginal delivery with control (either placebo or no treatment). Trials in women undergoing cesarean delivery and trials in prevention of PPH were excluded. The primary outcome was the incidence of hysterectomy. The summary measures were reported as summary relative risk (RR) with 95% of confidence interval (CI) using the random effects model of DerSimonian and Laird. Tabulation, integration, and results: Two trials including 14,363 women with established primary PPH after vaginal delivery were analyzed. Women who received TXA soon after the diagnosis of PPH had a significantly lower incidence of hysterectomy (0.5% vs 0.8%; RR 0.63, 95% CI 0.42–0.94), compared to those who did not. The risk of thrombotic events was not increased in the TXA group. Conclusion: In women with established PPH after vaginal delivery, the use of TXA reduces the risk of hysterectomy and does not increase the risk of thrombotic events. We recommend 1 g plus a second dose of 1 g if bleeding continues after 30 min.

Objectives:The primary objective was to quantify the risk of perinatal mortality in non‐anomalous monochorionic monoamniotic (MCMA) twin pregnancies complicated by birth‐weight (BW) discordance. The secondary objectives were to investigate the effect of inpatientvsoutpatient fetal monitoring on the risk of mortality in weight‐discordant MCMA twin pregnancies, and to explore the predictive accuracy of BW discordance for perinatal mortality. Methods:This analysis included data on 242 MCMA twin pregnancies (484 fetuses) from three major research collaboratives on twin pregnancy (MONOMONO, STORK and NorSTAMP). The primary outcomes were the risks of intrauterine (IUD), neonatal (NND) and perinatal (PND) death, according to weight discordance at birth from ≥ 10% to ≥ 30%. The secondary outcomes were the association of inpatientvsoutpatient fetal monitoring with the risk of mortality in weight‐discordant pregnancies, and the accuracy of BW discordance in predicting mortality. Logistic regression and receiver‐operating‐characteristics‐curve analyses were used to analyze the data. Results:The risk of IUD was significantly increased in MCMA twin pregnancies with BW discordance ≥ 10% (odds ratio (OR), 2.2; 95% CI, 1.1–4.4;P= 0.022) and increased up to an OR of 4.4 (95% CI, 1.3–14.4;P= 0.001) in those with BW discordance ≥ 30%. This association remained significant on multivariate logistic regression analysis for BW‐discordance cut‐offs ≥ 20%. However, weight discordance had low predictive accuracy for mortality, with areas under the receiver‐operating‐characteristics curve of 0.60 (95% CI, 0.46–0.73), 0.52 (95% CI, 0.33–0.72) and 0.57 (95% CI, 0.45–0.68) for IUD, NND and PND, respectively. There was no difference in the risk of overall IUD, single IUD, double IUD, NND or PND between pregnancies managed as an inpatient compared with those managed as an outpatient, for any BW‐discordance cut‐off. Conclusions:MCMA twin pregnancies with BW discordance are at increased risk of fetal death, signaling a need for increased levels of monitoring. Despite this, the predictive accuracy for mortality is low; thus, detection of BW discordance alone should not trigger intervention, such as iatrogenic delivery. The current data do not demonstrate an advantage of inpatient over outpatient management in these cases. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

The aim of this systematic review with meta-analysis was to evaluate the effect on length of labor when patients receive IVF with or without dextrose. Searches were performed in electronic databases from inception of each database to May 2018. Trials comparing intrapartum IVF containing dextrose (i.e. intervention group) with no dextrose or placebo (i.e. control group) were included. Only trials examining low-risk pregnancies in labor at ≥36 weeks were included. Studies were included regardless of oral intake restriction. The primary outcome was the length of total labor from randomization to delivery. The meta-analysis was performed using the random effects model. Sixteen trials (n = 2503 participants) were included in the meta-analysis. Women randomized in the IVF dextrose group did not have a statistically significant different length of total labor from randomization to delivery compared to IVF without dextrose (MD −38.33 min, 95% CI −88.23 to 11.57). IVF with dextrose decreased the length of the first stage (MD −75.81 min, 95% CI −120.67 to −30.95), but there was no change in the second stage. In summary, use of IVF with dextrose during labor in low-risk women at term does not affect total length of labor, but it does shorten the first stage of labor.

Introduction: To appraise the incidence and value of intrahepatic persistent right umbilical vein (PRUV). Methods: This was a single-center study. Records of all women with a prenatal diagnosis of intrahepatic PRUV were reviewed. The inclusion criteria were women with gestational age greater than 13 weeks of gestation. Exclusion criteria were fetuses with situs abnormalities, due to the hepatic venous ambiguity, and extrahepatic PRUV. The primary outcome was the incidence of intrahepatic PRUV in our cohort. The secondary outcomes were associated malformations. Results: 219/57,079 cases (0.38%) of intrahepatic PRUV were recorded. The mean gestational age at diagnosis was 21.8 ± 2.9 weeks of gestations. PRUV was isolated in the 76.7%, while in 23.3% was associated with other major or minor abnormalities. The most common associated abnormalities were cardiovascular abnormalities (8.7%), followed by genitourinary abnormalities (6.4%), skeletal abnormalities (4.6%), and central nervous system abnormalities (4.1%). Within the cardiovascular abnormalities, the most common one was ventricular septal defect (six cases). Conclusion: In most cases PRUV is an isolated finding. Associated minor or major malformations are presented in the 23.3% of the cases, so this finding should prompt detailed prenatal assessment of the fetus, with particular regard to cardiovascular system.

Vulvovaginal atrophy (VVA) is a condition frequently observed in menopause. Its symptoms can significantly affect the quality of life of patients. Since VVA is related to estrogen deficiency, chemotherapy and hormone therapy for breast cancer (BC) might cause VVA by inducing menopause. Given the lack of effective treatment for VVA in BC survivors, we retrospectively evaluated the efficacy and tolerability of fractional microablative CO2 laser therapy in these patients.We treated 82 BC survivors with three cycles of CO2 laser after failure of topical nonestrogenic therapy. The severity of symptoms was assessed with a visual analog scale (VAS) at baseline and after completion of laser therapy. Differences in mean VAS scores of each symptom before and after treatment were assessed with multiple t tests for pairwise comparisons. Multivariate analyses were used to adjust the final mean scores for the main confounding factors.Pre versus post-treatment differences in mean VAS scores were significant for sensitivity during sexual intercourse, vaginal dryness, itching/stinging, dyspareunia and dysuria (P 0.001 for all), bleeding (P = 0.001), probe insertion (P = 0.001), and movement-related pain (P = 0.011). Multivariate analyses confirmed that results were significant, irrespective of patients' age and type of adjuvant therapy.This study shows that CO2 laser treatment is effective and safe in BC patients with iatrogenic menopause. However, the optimal number of cycles to administer and the need for retreatment remain to be defined. Prospective trials are needed to compare CO2 laser therapy with therapeutic alternatives.

Objectives Given their inclusion and exclusion criteria, randomized clinical trials (RCT) might not include a population that truly mirrors real life (RL). This raises concerns about the applicability of RCT results in clinical practice. We evaluated the efficacy of anti-HER2 treatment with pertuzumab combined with trastuzumab and a taxane as first-line treatment for HER2-positive metastatic breast cancer in a RL setting, and compared the safety results obtained in our population versus the experimental cohort of the CLEOPATRA RCT, which led to the approval of this therapy. Materials and methods Patients treated with trastuzumab, pertuzumab and a taxane were enrolled in this retrospective study. We compared the tumor features and the patients' characteristics of the RL cohort to those of the CLEOPATRA cohort. We also compared the median progression-free survival (PFS) in the RL population versus specific patients' subgroups. Results RL patients were more frequently HR-positive, less likely to have visceral metastases (P

Objective Data Timing of artificial rupture of membranes (ie, amniotomy) in induction of labor is controversial, because it has been associated not only with shorter labors, but also with fetal nonreassuring testing, at times necessitating cesarean delivery. The aim of this systematic review and metaanalysis of randomized trials was to evaluate the effectiveness of early amniotomy vs late amniotomy or spontaneous rupture of membranes after cervical ripening. Study The search was conducted with the use of electronic databases from inception of each database through February 2019. Review of articles included the abstracts of all references that were retrieved from the search. Study Appraisal and Synthesis Methods Selection criteria included randomized clinical trials that compared early amniotomy vs control (ie, late amniotomy or spontaneous rupture of membranes) after cervical ripening with either Foley catheter or prostaglandins at any dose. The primary outcome was the incidence of cesarean delivery. The summary measures were reported as summary relative risk with 95% of confidence interval with the use of the random effects model of DerSimonian and Laird. Results Four trials that included 1273 women who underwent cervical ripening with either Foley catheter or prostaglandins and then were assigned randomly to either early amniotomy, late amniotomy, or spontaneous rupture of membranes (control subjects) were included in the review. Women who were assigned randomly to early amniotomy had a similar risk of cesarean delivery (31.1% vs 30.9%; relative risk, 1.05; 95% confidence interval, 0.71–1.56) compared with control subjects and had a shorter interval from induction to delivery of approximately 5 hours (mean difference, –4.95 hours; 95% confidence interval, –8.12 to –1.78). Spontaneous vaginal delivery was also reduced in the early amniotomy group, but only 1 of the included trials reported this outcome (67.5% vs 69.1%; relative risk, 0.78; 95% confidence interval, 0.66–0.93). No between-group differences were reported in the other obstetrics or perinatal outcomes. Conclusion After cervical ripening, routine early amniotomy does not increase the risk of cesarean delivery and reduces the interval from induction to delivery.

BACKGROUND: Postpartum hemorrhage (PPH) is responsible for about 25% of maternal deaths worldwide. Antifibrinolytic agents, mainly tranexamic acid, have been demonstrated to reduce maternal blood loss and need for transfusion requirements at delivery in some settings. OBJECTIVE: The aim of this meta-analysis of randomized controlled trials (RCTs) was to evaluate the effectiveness of tranexamic acid for the prevention of PPH after vaginal delivery. DATA SOURCES: The search was conducted using electronic databases from the inception of each database through February 2018. Review of articles also included the abstracts of all references retrieved from the search. No restrictions for language or geographic location were applied. STUDY DESIGN: Selection criteria included RCTs comparing the prophylactic use of tranexamic acid after vaginal delivery with control (either placebo or no treatment). Trials in women undergoing cesarean delivery and trials in women with established PPH were excluded. The primary outcome was the incidence of primary PPH. The summary measures were reported as summary relative risk (RR) with 95% confidence interval (CI) using the random-effects model of DerSimonian and Laird. TABULATION, INTEGRATION, AND RESULTS: Four RCTs, including 4671 participants, evaluating tranexamic acid usually 1 g intravenous (IV) within 10 min after vaginal delivery in addition to oxytocin, cord traction, and uterine massage, at or near term for prevention of primary PPH, defined mostly as blood loss ≥500 mL in the first 24 h following delivery, were analyzed. Women who received prophylactic tranexamic acid after vaginal delivery had a significantly lower incidence of primary PPH (8.7 versus 11.4%; RR 0.61, 95% CI 0.41-0.91) and lower mean blood loss mean difference (MD) -84.74 mL, 95% CI -109.76 to -59.72). The risk of thrombotic events was not increased in the tranexamic acid group. CONCLUSIONS: Prophylactic tranexamic acid 1 g IV within 10 min after vaginal delivery reduces the risk of primary PPH.

Fetal lymphangioma is a rare congenital malformation of lymphatic system that involve the skin and the subcutaneous tissue. The vast majority of the lymphangioma occurs in the neck. More rarely lymphangiomas may occur in the axillary region, including chest wall. Our consecutive case series study included three cases of fetal chest wall cystic lymphangiomas. In our cohort, fetal chest wall cystic lymphangiomas were the 18.8% of the all cases of lymphangiomas of axillary region. In all the three cases no other fetal abnormalities were evaluated, and the chest wall cystic lymphangiomas were unilateral, honeycombed in appearance, with multiple echo-free area of varying size in the mass, with no color flow on Doppler sonography, and with a trend to increase during the gestation. The incidence of chromosomal abnormalities was 33.3%, with one case out of the three being trisomy 21.The literature review revealed only seven cases of fetal chest wall cystic lymphangiomas. The cases were not associated with other abnormalities, nor with abnormal karyotype and only one case of fetal death was reported. Three women delivered vaginally. In summary, fetal chest wall cystic lymphangioma is a very rare malformations with only seven cases reported in the literature. This malformation is usually not associated with abnormal karyotype or other abnormalities and the neonatal outcome is favorable after surgical removal. Spontaneous vaginal delivery may be a safe approach for delivery women with fetal chest wall cystic lymphangioma. CONDENSATION: Fetal chest wall cystic lymphangioma is a very rare malformations with only seven cases reported in the literature. This malformation is usually not associated with abnormal karyotype or other abnormalities and the neonatal outcome is favorable after surgical removal. Spontaneous vaginal delivery may be a safe approach for delivery women with fetal chest wall cystic lymphangioma.

Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate.This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at37 weeks of gestation.This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment.A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30).In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at37 weeks of gestation.

Study Objective To assess if any difference could be found in uterine vascularization between septate and bicornuate uterus. Design Pilot study (Canadian Task Force classification II-2). Setting University hospital infertility clinic. Patients One hundred nine women with complete duplication of the uterine cavity. All had already received the final diagnosis of the type of uterine malformation, either septate uterus or bicornuate uterus, via diagnostic hysteroscopy and laparoscopy. Another group of 10 patients with uterine anomalies and affected by ovarian mass were also evaluated via intravenous contrast medium–enhanced ultrasound examination. Interventions Patients were evaluated using 2-dimensional and 3-dimensional power Doppler imaging of the uterus. Measurements and Main Results Seventy-three patients with septate uterus, with or without cervical and vaginal duplication, and 36 patients with bicornuate uterus were selected for inclusion in the study. Irregular vascular networks were detected between the 2 hemicavities in the patients with septate uterus. All bicornuate uteri showed a peculiar vascular network between the 2 hemicavities: the main recognizable vessels formed a network depicting the Greek letter γ at the level of the uterine midline. Detection of the γ sign can be used to differentiate septate from bicornuate uterus. This finding was also confirmed in patients who underwent intravenous contrast medium–enhanced ultrasound examination. Conclusions power Doppler provides a new and uninvasive tool for differentiation of septate from bicornuate uterus.

A total of 3,324 singleton pregnant women were screened for pre-term delivery and 128 women were finally randomised and analysed for outcome showing borderline cervical length (25-29 mm) and elevated cervico-vaginal interleukin 6 levels. To verify if vaginal administration of lactoferrin might have an influence on these variables, two groups of 64 patients were formed. Study cases were submitted to lactoferrin for 21 days; controls received no treatment. An inverse relation was found between interleukin 6 levels and cervical length. On day 30 from the beginning of the treatment, study cases showed a decrease in interleukin 6 levels and an increase in cervical length. A greater number of women with regular uterine contractions and reduced cervical consistency before the 37th week of gestation were found in the controls. Our data show that lactoferrin could play a role in reducing the number of women at risk for pre-term birth for shortened cervical length and elevated interleukin 6 levels.

OBJECTIVES: Breast cancer is one of the most common malignancies in women. Hormonal treatment and chemotherapy induce a transient or permanent menopause status. Vulvovaginal atrophy (VVA) is a frequent debilitating symptom of menopause that is best treated with local or systemic estrogen formulations. Because estrogens drive the growth of the majority of breast cancers, most effective VVA therapies are precluded. The aim of this study was to evaluate the effects of fractional microablative CO2 laser on sexual function and in relieving symptoms in women with breast cancer and VVA induced or exacerbated by iatrogenic menopause. METHODS: This retrospective study included 26 women affected by hormone-receptor positive breast tumors and treated for VVA symptoms with the fractional microablative CO2 laser system. Every 30 to 40 days, women underwent a cycle of treatment for a total of three cycles. During each cycle, women underwent a gynecological examination and completed visual analog scale questionnaires designed to assess (1) the degree of symptoms and (2) procedure-related discomfort. RESULTS: Treatment resulted in a significant regression of VVA symptoms and procedure-related discomfort versus baseline (P

Our objective was to compare the effectiveness and safety of atosiban and ritodrine, in pregnancies obtained by intracytoplasmic sperm injection (ICSI) undergoing cervical cerclage. Data from a prospective study were compared with those from a retrospective study. Sixteen ICSI pregnant women, 20 - 24 weeks' gestation and maternal age >18 years, received atosiban (bolus dose 6.75 mg i.v., followed by 300 μg/min i.v. for 3 h and 100 μg/min i.v. for 45 h). Cervical cerclage was performed 3 h after starting atosiban. The control group (group B) of 16 ICSI pregnant women were matched and received ritodrine hydrochloride (100 - 350 μg/min) for 48 h. Cervical cerclage was performed after 24 h. Pre-term rupture of membranes occurred within 48 h of cervical cerclage in one woman receiving atosiban and in four women receiving ritodrine. There was no significant difference in terms of pregnancies not delivered at 48 h (short-term tocolysis) and at 7 days (long-term tocolysis). However, there was a significantly higher incidence of maternal tachycardia with ritodrine compared with atosiban (p