Sleep and sleep disorders during pregnancy and postpartum: The Life-ON study.

OBJECTIVE: to prospectively assess sleep and sleep disorders during pregnancy and postpartum in a large cohort of women. METHODS: multicenter prospective Life-ON study, recruiting consecutive pregnant women at a gestational age between 10 and 15 weeks, from the local gynecological departments. The study included home polysomnography performed between the 23rd and 25th week of pregnancy and sleep-related questionnaires at 9 points in time during pregnancy and 6 months postpartum. RESULTS: 439 pregnant women (mean age 33.7 ± 4.2 yrs) were enrolled. Poor quality of sleep was reported by 34% of women in the first trimester of pregnancy, by 46% of women in the third trimester, and by as many as 71% of women in the first month after delivery. A similar trend was seen for insomnia. Excessive daytime sleepiness peaked in the first trimester (30% of women), and decreased in the third trimester, to 22% of women. Prevalence of restless legs syndrome was 25%, with a peak in the third trimester of pregnancy. Polysomnographic data, available for 353 women, revealed that 24% of women slept less than 6 h, and 30.6% of women had a sleep efficiency below 80%. Sleep-disordered breathing (RDI≥5) had a prevalence of 4.2% and correlated positively with BMI. CONCLUSIONS: The Life-ON study provides the largest polysomnographic dataset coupled with longitudinal subjective assessments of sleep quality in pregnant women to date. Sleep disorders are highly frequent and distributed differently during pregnancy and postpartum. Routine assessment of sleep disturbances in the perinatal period is necessary to improve early detection and clinical management.

Increasing Vaccine Uptake during Pregnancy by Using Prenatal Education Classes: An Effective Tool for Health Communication and Promotion.

Childbirth education classes represent an antenatal tool for supporting pregnant women and couples in increasing knowledge on pregnancy, delivery, breastfeeding, and newborn care. The aim of this study was to investigate the impact of an additional lesson during the prenatal course regarding the advantage of vaccination to mitigation of maternal anxiety. An observational study was designed that included participants in childbirth education classes and compared courses enhanced by the extra lesson on vaccination during pregnancy versus those who did not receive it. Assessment of the impact of prenatal educational on vaccination was measured by using validated questionnaires (State-Trait Anxiety Inventory, STAI; Perceived Stress Scale, PSS; World Health Organization- Five Well-Being Index, WHO-5). A total of 145 pregnant women participated to the investigation by answering to the online survey. Of them, 33 patients (22.8%) belonged to the course without a lesson on vaccine, while 112 (77.2%) participated to online prenatal education that included an additional meeting on the usefulness of getting vaccinated during pregnancy. No statistical differences were found between study groups in terms of demographics and perinatal outcomes. Participants in the enriched course reported lower basal anxiety levels than those without the vaccine lesson (STAI-State, normal score < 40, 30 vs. 19%, p-value 0.041; STAI-State, mild score 40-50, 78 vs. 67%, p-value 0.037). With reference to the prior two weeks, maternal wellbeing level was improved by the added class (score > 13 as measurement of wellbeing: 62% vs. 80%, p-value < 0.05). Moderate perceived stress assessed by PSS was found in those pregnant women without prenatal education on vaccination (64 vs. 50%, p-value 0.042). The introduction of a lesson regarding vaccination during pregnancy in the program of prenatal education courses improved maternal anxiety levels and wellbeing, in addition to reducing perceived stress.

Robotic multiple sigmoid and rectal mucosa skinning in a multicentric deep infiltrating bowel endometriotic nodules: a case report.

Endometriosis is a benign gynecological disease characterized by the presence of endometrial tissue outside the uterus. The eradication of non-gynecological localizations represents the real surgical challenge. A 29-year-old woman underwent robotic surgery with the Da Vinci system (Intuitive Surgical Inc.) for a diagnosis of stage IV deep endometriosis. The patient presented with 5 cm left ovarian endometrioma, an infiltration of the left posterior parametrium, and bilateral ureteral endometriosis. Once inside the pelvic cavity, deep intestinal infiltrating endometriosis implants were confirmed as triple, multicentric, and multifocal lesions, affected distal sigmoid, rectosigmoid junction, and upper rectum. An expert multiple excision, sparing the intestinal mucosa, was performed. To our knowledge, this is the first description of a multiple robotic shaving of multicentric endometriotic intestinal lesions. After the surgery, a normal diet was quickly restored, accelerating the recovery of the physiological peristalsis and the overall recovery time.

Reducing vaccine hesitancy in pregnancy by the health literacy model inclusive of modern communication tools.

Albeit the vaccination is one of the most successful and cost-effective public health interventions, reluctance or refusal to vaccinate represents one of the ten threats to global health by the World Health Organization. Additional efforts to promote vaccination are required for at higher risk categories, such as pregnant women. Our approach supports the role of a clear and transparent communication by using efficient interventions and educational strategies to increase both willingness and confidence for preventable diseases in neonates and infants by vaccinations in pregnancy.

Prior Robotic Console Expertise May Improve Basic Skills at the New Hugo RAS Simulator: Results from a Cohort Trial and Implications for Skill Transference Across Platforms.

Background: Robot-assisted surgery ensures minimal invasiveness; since the expiry of the Da Vinci patent, new robotic systems have entered the market. Recently, the Hugo RAS received CE approval for several surgical procedures. However, more is needed to know about skill acquisition at the new simulator. Objective: This study aims to analyse the factors impacting basic surgical skills at the Hugo RAS simulator. Design setting and participants: We present a cross-sectional study involving 71 participants of different backgrounds invited to a hands-on session with the Hugo RAS simulator voluntarily. All of them had no prior expertise with the system. Participants were recruited among medical/nurse students, residents, and laparoscopic and robotic surgeons. Intervention: All participants underwent a hands-on "pick and place" exercise at the Hugo RAS simulator; the metrics of a second-round pick and place exercise were recorded. Outcome measurements and statistical analysis: Metrics were analysed with regard to the following variables: demographics, videogame use, and prior surgical experience (no surgical expertise, experience with laparoscopy, and experience with robotic console). Results and limitations: All participants completed the test. Of them, 77.5% were naïve to surgery, 8.5% had prior laparoscopic expertise, and 14.1% had prior robotic console experience. The time to complete the pick and place exercise was significantly lower (p < 0.001) among prior robotic surgeons (38 s, interquartile range [IQR] 34-45) compared with both naïve participants (61 s, IQR 53-71) and laparoscopists (93 s, IQR 53-162). The overall score of the exercise decreased with age (p = 0.046); however, the overall scores were significantly and steadily higher among surgeons experienced in robotic consoles across all age groups (p = 0.006). Neither gender (p = 0.7) nor videogame use (p = 0.9) correlated significantly with the metrics. Conclusions: This is the first study analysing factors impacting basic skill acquisition at a new robotic simulator. Experience with robotic consoles may represent a major factor, raising the hypothesis of the transferability of basic robotic skills across different robotic systems. Further studies are required to explore this issue. Patient summary: In the present study, we analysed which characteristics may affect the basic surgical skills at a novel robotic platform.

Impact of hands-on practice with HugoRAS and Versius System simulators on the attractiveness of robotic surgery among medical and nurse undergraduate students.

The scenario of robotic surgery is rapidly evolving with the introduction of new robotic systems. A structured learning program in robotic surgery during academic education is often lacking, especially for undergraduates; as a result, many students may be unaware of indications to robotic surgery and technological progress. The aim of the study is to evaluate the knowledge and interest toward robotic surgery of medical and nurse students, and to analyze how the attractiveness may change after a hand-on training course with new simulators of Hugo RAS and Versius System. We performed a cross-sectional study involving medical and nurse students recruited on a voluntary basis at ASST Santi Paolo and Carlo, Milan; participants were invited to join a hands-on practice simulation with the Hugo RAS and/or Versius Trainer Simulator. Before the hand-on exercise, students were asked to fulfill an online anonymous questionnaire addressing knowledge and interest toward robotic surgery. After a 2-h hands-on exercises at the Hugo RAS and/or at the Versius Trainer simulator (preceded by a brief lecture on robotic surgery and new systems), participants were asked to complete a second-round questionnaire to evaluate changes in attractiveness toward robotic surgery. Data were recorded in a database; after a descriptive analysis of the variables, median values were compared with the Mann-Whitney U test, frequencies with the Fisher's exact test and in the case of paired observations (before and after the simulation), the Mc Nemar test was used. Forty-one undergraduates agreed to participate. Twenty-three nursing students and 18 medical students were recruited. Some of them had a basic knowledge in robotic surgery and were able to figure out some surgical indications, given the presence of a robotic program already settled up at the institution. Before the hands-on course, 44.0% nurse students and 36.6% of medical students were interested in surgical disciplines and robotic surgery. After the simulation, all students (100%) reported a high level of interest in robotic surgery and some of them required for a dedicated internship (p < 0.001). The students provided also feedback on the perceived ease-of-use of the robotic simulators (on a scale 0-10); overall, the median score was 8, IQR [7-8], with no differences between nursing and medical students (p = 0.482). In conclusion, the study demonstrates a great interest toward robotic surgery as a part of medical and nurse education. A hands-on simulation further improved the interest of undergraduates from both backgrounds. The technological progress with the availability of new surgical systems will be the future challenge of training programs and should be considered at all levels of education.

Emotional and autonomic response to visual erotic stimulation in patients with functional hypothalamic amenorrhea.

Introduction: Functional hypothalamic amenorrhea (FHA) is a clinical condition associated with high levels of physiological and psychological stress ranging from weight loss to maladaptive behavior and coping skills. A reliable measure of the psychophysiological response to stress and the ability to cope with stimuli is heart rate variability (HRV). Through the sympathetic (SNS) and parasympathetic nervous system (PNS), the autonomic nervous system (ANS) promotes various changes in HRV that reflect the individual's psychophysiological response to stress. FHA patients are characterized by high levels of PNS activation during psychological load, suggesting that parasympathetic hyperactivation could be a pathology marker. Methods: In the present study, we examine changes in HRV during observation of erotic, neutral, and disgusting images in 10 patients with FHA [(mean ± S.D.) age: 26.8 ± 5.9] and in 9 controls (age: 25.4 ± 6.4; BMI: 22.47 ± 2.97) to assess the differential activation of PNS and SNS between FHA patients and controls matched for age and without other clinical conditions. Results: Our results showed that FHA patients had significantly higher HRV activation while observing high emotional value images and not during the observation of neutral images confirming a parasympathetic hyperactivation. Discussion: HRV and cognitive and psychological testing, could provide new insights into understanding such a clinically understudied condition and provide further tools for clinical diagnosis and treatment.

Basal serum level of Δ4-androstenedione reflects the ovaries' ability to respond to stimulation in IVF cycles: setting up a new reliable index of both ovarian reserve and response.

PURPOSE: Adequate androgen levels are necessary for regular follicular growth, progression beyond the pre-antral stage, and prevention of follicular atresia. The main purpose of this study was to investigate whether baseline androgen levels had a predictive value on stimulation outcomes in IVF cycles. The secondary purpose was to compare the possible predictive value of androgens with that of already known markers. METHODS: The study included 91 infertile patients aged 30-45 years awaiting the first IVF cycle. All women underwent the same stimulation protocol and the same starting dose of recombinant FSH. As stimulation outcomes, the number of follicles recruited, estradiol and progesterone levels on the day of trigger, the total dose of gonadotropins administered, and the number of oocytes collected were recorded. Multiple linear regression and multivariate logistic regression were used to evaluate the significant predictive value of the variables for response to controlled ovarian stimulation (COS). By studying the reliability of different markers, an attempt was made to develop a single index with the highest predictive value. RESULTS: Pearson's correlation revealed a statistically significant inverse correlation between oocytes collected and age (r = - 0.333, p < 0.001) and a positive correlation with AMH (anti-müllerian hormone) (r = 0.360, p < 0.001), antral follicle count (AFC) (r = 0.639, p < 0.001), and androstenedione (Δ4-A) (r = 0.359, p < 0.001). No significant correlation was reported with FSH (r = - 0.133, p = 0.207) and total testosterone (r = 0.180, p = 0.088). In COS good responders, the G-index (= AMH ng/mL*AFC/Δ4-A ng/dL) revealed a significantly higher level (p < 0.001) than AMH, AFC, and Δ4-A alone. CONCLUSION: Baseline serum Δ4-A, presumably crucial for ensuring a regular follicular growth, is a reliable marker of ovarian response to stimulation. Since the ovarian capacity to respond to gonadotropins does not depend exclusively on the presence of follicles, we suggest a new index, the G-index, able to contemplate both the ovarian reserve and the Δ4-A level.

Assessment of post-partum haemorrhage risk among women with moderate thrombocytopenia.

It is unknown whether moderate thrombocytopenia represents a risk factor for post-partum haemorrhage (PPH). We assessed PPH risk among women with a platelet count of between 100 and 50 × 109 /l and stratified the risk for O/non-O blood group. We included consecutive women undergoing vaginal delivery or caesarean section with moderate thrombocytopenia. Women with >150 × 109 /l platelets at delivery were selected as controls and matched for age, type of birth and ethnicity. Odds ratios (ORs) with their 95% confidence intervals (95% CIs) were calculated as risk estimates. A total of 94 thrombocytopenic women and 94 controls were included in the study. The rate of PPH was significantly higher in thrombocytopenic women than in controls (37% vs. 10%, p < 0.001); there was a higher risk of PPH in the thrombocytopenic group when compared to the control group (adjusted OR 4.7, 95% CI 2.1-10.8, p < 0.01) and this association was stronger in blood group O carriers (adjusted OR 11.0, 95% CI 2.4-49.6, p < 0.01). In conclusion, our study shows that a moderate thrombocytopenia is a risk factor for PPH, especially in blood group O carriers.

Hyperandrogenism and menstrual imbalance are the best predictors of metformin response in PCOS patients.

BACKGROUND: Moving from the correlation between insulin-resistance and PCOS, metformin has been administered in some PCOS women improving ovulatory and metabolic functions and decreasing androgen levels. Inconsistency and unpredictability of response to metformin limit its extensive use. Aim of this study was to identify reliable predictors of response to metformin therapy for weight loss and reduction in plasma androgen levels using ANNs (artificial neural networks). METHODS: One hundred eight consecutive women with PCOS (ESHRE/ASRM 2003 Rotterdam criteria) treated with metformin 1500 mg/day, at inclusion and every 6 months underwent to a complete clinical, endocrine/metabolic assessment and ultrasonographic evaluation. Therapy outcomes were BMI reduction (≥1 kg/m2) in overweight/obese and free-androgen-index (FAI) decrease (≥1%) in hyperandrogenemic women. Semantic connectivity maps (SCMs) were obtained through Auto-CM, a fourth generation ANN, to compare patients' baseline clinical features to the treatment outcomes. Multivariate logistic regression analysis was used to assess the major predictor in drop-out patients and the associated risk. RESULTS: At 6 months 54 out of 103 (52,4%) obese patients showed BMI reduction and 45 out of 89 (50,6%) hyperandrogenemic women showed FAI decrease. The further response rates at 12 months were 30,6 and 47%, respectively. SCMs showed a clear polarization for both the outcomes with elevated accuracy. Treatment responsiveness resulted strictly related to oligo-amenorrhea and hyperandrogenemia at baseline. In addition, lower serum testosterone levels at baseline were found to be the major predictor of treatment discontinuation. CONCLUSIONS: In women with PCOS, menstrual pattern imbalance and ovarian androgens excess are the best predictors of metformin response. They may pave the way for a rethinking of the criteria for evaluating hyperandrogenism in order to better define the large population included in the diagnosis of PCOS. Baseline plasma testosterone level can serve as a sensitive marker to predict treatment compliance.

SARS-CoV-2 infection testing at delivery: a clinical and epidemiological priority.

BACKGROUND: Universal testing has been suggested as a useful strategy for a safe exit from the total lockdown, without recurrence of COVID-19 epidemic, delivering women being considered a sentinel population. Further universal testing for pregnant women may be useful in order to define appropriate access to COVID19 areas, dedicated neonatal care, and personal protective equipment. METHODS: During the period 10-26 April, all consecutive women admitted for delivery at the Maternity Hospitals of the city of Milan and in six provinces of Lombardy: Brescia, Como, Lecco Monza, Pavia, and Sondrio. areas were tested with nasopharyngeal swabs.Results and conclusion: Out of 1566 women, 49 were tested positive for SARS-Cov-2 (3.1%, 95% Confidence Interval (CI) 2.3-4.0). This value is largely higher than Heath Authorities estimate. Of tested positive women, 22 (44.9%) had symptoms or reported close contacts with positive patients, that is were found at risk by the itemized questionnaire. In conclusion, routine estimate of frequency of positivity among delivering women can be consider a useful methods to monitor positivity at least in females in their fertile ages.

Cesarean section rate is a matter of maternal age or parity?

OBJECTIVE: To determine the impact of women's age on the cesarean section (CS) rate according to Robson groups 1, 2A, 3 and 4A. STUDY DESIGN: Retrospective cohort study of term, livebirth, singleton pregnancies with spontaneous or induced labor who delivered at the San Paolo Hospital from 1996 through 2019, and had the Robson group assigned. Women were grouped in 5 age classes (≤24, 25-29, 30-34, 35-39 and ≥40 years). The primary outcome was the rate of CS. RESULTS: 24 843 women were included: 36.4% classified as Robson group 1, 18.9% as Robson group 2A, 34.4% as Robson group 3 and 10.2% as Robson group 4A. The CS rate of women in Robson groups 1, 2A, 3 and 4A was 6.6%, 21.8%, 1.6% and 4.3% respectively. In nulliparous women [Robson groups 1 and 2A] group 1, the adjusted OR of CS increased steadily from 30 to ≥40 years, when compared to women aged 25-29 years. On the contrary, in multiparous women [Robson groups 3 and 4A] significant increased OR were present only for women ≥40 years. In young women [≤24 years] there was a significant reduction in the number of cesarean sections only in Robson group 1. CONCLUSION: The results of our study show that multiparous women aged ≥40, either in spontaneous or induced labor have an independent twofold increased risk of delivering by cesarean section when compared to women of 25-29 years. On the contrary, in nulliparous women, the risk slightly, but significantly, increases with age and again becomes twofold in women ≥40 years.

Stem Cells in Clinical Trials for Pelvic Floor Disorders: a Systematic Literature Review.

Pelvic floor disorders (PFDs) include a series of conditions that can be poorly tolerated, negatively affecting the quality of life. Current treatment options show unsatisfactory results and new ones are therefore needed. Stem cell (SC) therapy might be an alternative treatment strategy. This systematic review aims to define the state of art of SC therapy for PFDs in clinical trials, by systematically reviewing the available evidence. A systematic search strategy was conducted up to November 7, 2020, in PubMed, Scopus, Cochrane Library, and ISI Web of Science. Preclinical studies on animal models were not considered. Studies were included when the patients were affected by any PFDs and cells were isolated, cultured, and characterized as SC. The study protocol was registered in PROSPERO (CRD42020216551). A total of 11 prospective clinical studies were included in the final assessment, specifically 7 single-arm studies dealing with SC therapy for stress urinary incontinence and 4 with anal incontinence. Among the latter, there were two prospective, single-arm studies and two randomized controlled trials. No papers concerning the use of SC for prolapse repair were retrieved. Due to the great heterogeneity, data pooling was not possible. Stem cell injection resulted in a safe procedure, with few mild adverse side effects, mostly related to harvesting sites. However, a clear beneficial impact of SC treatment for the treatment of pelvic floor disorders could not be demonstrated. Further larger targeted studies with control arms are needed before any conclusions can be made.

Predictors of low ovarian reserve in cART-treated women living with HIV.

ABSTRACT: Ovarian dysfunction and lower circulating anti-Müllerian hormone (AMH) feature women living with HIV (WLWH). Because treated human immunodeficiency virus (HIV) infection is characterized by a pro-inflammatory/oxidative phenotype resulting in residual comorbidity, we sought to investigate possible associations between plasma AMH and markers of inflammation, immune activation/senescence/exhaustion, oxidative stress as well as comorbidities in a cohort of combined anti-retroviral therapy (cART)-treated WLWH versus age-matched HIV-uninfected, healthy women.Eighty WLWH on effective cART aged 25 to 50 years and 66 age-matched healthy women were enrolled. We measured: plasma AMH, IL-6, reactive oxygen species modulator 1 (ROMO1) (ELISA); plasma tumor necrosis factor α, IL-10, soluble vascular cell adhesion molecule 1, osteopontin (Luminex); CD4/CD8 activation (CD38/CD69), apoptosis (CD95), exhaustion (PD1), maturation (CD45RA/CD45R0/CD127/CCR7), recent thymic emigrants (CD31/CD103) (flow cytometry). Mann Whitney and chi-squared tests were used. Univariate and multivariate logistic regression analyses were used to assess factors associated with low AMH (≤1 ng/mL).Compared to healthy women, WLWH were more frequently non-Caucasian, drug/alcohol abusers, with history of late menarche, lower hormonal contraceptive use, with higher gravidity and lower parity. WLWH showed significantly lower AMH (P = .004) as well as higher ROMO1 (P = .0003) and tumor necrosis factor α (P < .0001). The multivariate analyses revealed ROMO1 (adjusted odds ratio [AOR]: 1.42, P = .03) and HIV infection (AOR: 8.1, P = .0001) as independently associated with low AMH. The logistic regression model with both HIV status and ROMO1 (a marker of oxidative stress) confirmed HIV as the only predictor of low AMH (AOR: 17, P = .0003).Despite effective cART, WLWH showed lower AMH compared to age-matched peers, indicating pre-mature ovarian ageing. Both HIV and oxidative stress are independently associated with low AMH, emphasizing the impact of HIV-associated oxidative stress on reproductive aging.

"Add-Ons" for Assisted Reproductive Technology: Do Patients Get Honest Information from Fertility Clinics' Websites?

"Add-on" procedures are actively promoted on some fertility clinic websites as proven means to improve IVF success rates, especially for couples with repeated implantation/IVF failures. However, the actual contribution of these interventions to live birth rates remains inconclusive. At present, little is known about the type and quality of the information provided on the IVF clinics' websites regarding the merits of "add-ons." A systematic evaluation of the quality of information on "add-on" procedures in fertility clinic websites was performed using 10-criteria structured questionnaire. We included English language websites that presented in the Google.com search engine after typing the following key-words:"endometrial scratching"(ES), "intralipid infusions"(ILI), "assisted hatching"(AHA), "PGT-A," or "PGS". In total, 254 websites were evaluated. In most cases, an accurate description of the "add-on" procedures was provided (78.8%). However, only a minority (12%) reported their undetermined effectiveness. The use of PGT-A was more often encouraged (52.8%) than ES (23.6%) and AHA (16%). The cost was infrequently presented (6.9%). Scientific references were only rarely provided for ILI, versus 12.7% for ES, 4.0% for AHA, and 5.6% for PGT-A. The information entry date was often missing. None of the websites reported the clinic's pregnancy-rate following the "add-on" procedures. Information on "add-ons" available to patients from IVF clinic websites is often inaccurate. This could perpetuate false myths among infertile patients about these procedures and raises concern regarding possible commercial bias. It is imperative that IVF clinic websites will better communicate the associated risks and uncertainties of "add-ons" to prospective patients.

Percutaneous microwave ablation of uterine fibroids: correlation between shrinkage and trend symptoms.

PURPOSE: To assess a correlation between the shrinkage of the fibroid and the course of the symptoms. MATERIAL AND METHODS: Fourteen patients with symptomatic uterine leiomyomas (mean fibroid volume: 111.45 cm3) underwent percutaneous microwave ablation. Contrast-enhanced MRI follow-up was performed before and after treatment to evaluate the volume shrinkage. Two scores obtained from the Uterine Fibroids Symptom and Quality of Life questionnaire were used to perform a clinical follow-up to evaluate the symptoms and the quality of life at baseline, and at 3, 6 and 12 months after treatment. RESULTS: All patients were treated, no complications occurred. During a mean MR follow-up of 8.1 months we observed shrinkage of the fibroids in all patients (mean 70.3 cm3). During 12 months clinical follow-up, we observed a significant improvement of symptoms and an excellent improvement of quality of life (p < .001). CONCLUSION: Uterine fibroids percutaneous microwave ablation is a safe tool to obtain a significant improvement in quality of life for all the patients of our cohort.