Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study.

BACKGROUND: Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length screening program in women at low risk for preterm delivery is associated with a reduction in the frequency of preterm birth. OBJECTIVE: To test the hypothesis that the introduction of a midtrimester universal transvaginal ultrasound cervical length screening program in asymptomatic singleton pregnancies without prior preterm delivery would reduce the rate of preterm birth at <37 weeks of gestation. STUDY DESIGN: This study was a multicenter nonblinded randomized trial of screening of asymptomatic singleton pregnancies without prior spontaneous preterm birth, who were randomized to either cervical length screening program (ie, intervention group) or no screening (ie, control group). Participants were randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks of gestation. Women randomized in the screening group received cervical length measurement. Those who were found to have cervical length ≤25 mm were offered 200 mg vaginal progesterone daily along with cervical pessary. The primary outcome was preterm birth at <37 weeks. The risk of primary outcome was quantified by the relative risk with 95% confidence interval, and was based on the intention-to-screen principle. RESULTS: A total of 1334 asymptomatic women with singleton pregnancies and without prior preterm birth, were included in the trial. Out of the 675 women randomized in the transvaginal ultrasound cervical length screening group, 13 (1.9%) were found to have transvaginal ultrasound cervical length ≤25 mm during the screening. Preterm birth at <37 weeks of gestation occurred in 48 women in the transvaginal ultrasound cervical length screening group (7.5%), and 54 women in the control group (8.7%) (relative risk, 0.86; 95% confidence interval, 0.59-1.25). Women randomized in the transvaginal ultrasound cervical length screening group had no significant differences in the incidence of preterm birth at less than 34, 32, 30, 28, and 24 weeks of gestation. CONCLUSION: The introduction of a universal transvaginal ultrasound cervical length screening program at 18 0/6 to 23 6/7 weeks of gestation in singleton pregnancies without prior spontaneous preterm birth, with treatment for those with cervical length ≤25 mm, did not result in significant lower incidence of preterm delivery than the incidence without the screening program.

Prevalence and burden of nausea and vomiting in pregnant women: Interim analysis of the PURITY survey.

OBJECTIVES: Nausea and vomiting in pregnancy is a common and invalidating condition in early pregnancy. However, no data are available on its prevalence in Italy. This survey aims to evaluate the prevalence and impact of nausea and vomiting during pregnancy on the quality of life of Italian women. STUDY DESIGN: The survey was performed in three Italian public University Hospitals in two distinct periods: a first interview took place between the 18th and 22nd week of pregnancy, using the Questionnaire for Pregnancy Period (14 questions regarding demographic data and 30 questions about nausea and vomiting in pregnancy, including Pregnancy-Unique Quantification of Emesis questionnaire), and a follow-up interview, by telephone call, took place immediately after giving birth and in any case within 14 days of delivery, using the Questionnaire for Post-Pregnancy (9 questions). Included women were Caucasian, in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound), able to communicate adequately with the interviewer, understand the questionnaires and able to provide valid informed consent. Twin pregnancies and women who recurred to medically assisted procreation were excluded. This is an interim report on data collected from 232 of the planned 600 women. RESULTS: Mean age of the recruited subjects was 32.6 ± 4.6 years, with approximately 60% primiparous. The prevalence of nausea and vomiting in pregnancy in the sample examined was 65.5% overall (152 out of 232 subjects). Of these 152 women, 63 (41.4%) experienced only nausea, 6 (3.9%) only vomiting, and 83 (54.6%) reported both. Symptoms were reported to begin at 7.2 ± 2.7 weeks, lasted 10.2 ± 5.6 weeks, and persisted at the time of the interview in 32.2% of cases. Overall, over 50% of the women interviewed experienced a negative impact of nausea and vomiting in pregnancy on social relationships and work activity. CONCLUSIONS: A high prevalence of nausea and vomiting in pregnancy, 65.5% overall, was found in this interim analysis. These symptoms appeared capable of negatively influencing women quality of life. Screening procedures should be offered during pregnancy and measures that address nausea and vomiting in pregnancy impact warranted.

Computational reactive-diffusive modeling for stratification and prognosis determination of patients with breast cancer receiving Olaparib.

Mathematical models based on partial differential equations (PDEs) can be exploited to handle clinical data with space/time dimensions, e.g. tumor growth challenged by neoadjuvant therapy. A model based on simplified assessment of tumor malignancy and pharmacodynamics efficiency was exercised to discover new metrics of patient prognosis in the OLTRE trial. We tested in a 17-patients cohort affected by early-stage triple negative breast cancer (TNBC) treated with 3 weeks of olaparib, the capability of a PDEs-based reactive-diffusive model of tumor growth to efficiently predict the response to olaparib in terms of SUVmax detected at 18FDG-PET/CT scan, by using specific terms to characterize tumor diffusion and proliferation. Computations were performed with COMSOL Multiphysics. Driving parameters governing the mathematical model were selected with Pearson's correlations. Discrepancies between actual and computed SUVmax values were assessed with Student's t test and Wilcoxon rank sum test. The correlation between post-olaparib true and computed SUVmax was assessed with Pearson's r and Spearman's rho. After defining the proper mathematical assumptions, the nominal drug efficiency (εPD) and tumor malignancy (rc) were computationally evaluated. The former parameter reflected the activity of olaparib on the tumor, while the latter represented the growth rate of metabolic activity as detected by SUVmax. εPD was found to be directly dependent on basal tumor-infiltrating lymphocytes (TILs) and Ki67% and was detectable through proper linear regression functions according to TILs values, while rc was represented by the baseline Ki67-to-TILs ratio. Predicted post-olaparib SUV*max did not significantly differ from original post-olaparib SUVmax in the overall, gBRCA-mutant and gBRCA-wild-type subpopulations (p > 0.05 in all cases), showing strong positive correlation (r = 0.9 and rho = 0.9, p < 0.0001 both). A model of simplified tumor dynamics was exercised to effectively produce an upfront prediction of efficacy of 3-week neoadjuvant olaparib in terms of SUVmax. Prospective evaluation in independent cohorts and correlation of these outcomes with more recognized efficacy endpoints is now warranted for model confirmation and tailoring of escalated/de-escalated therapeutic strategies for early-TNBC patients.

Perinatal depression during the fourth wave of the COVID-19 outbreak in a single prenatal clinic in Southern Italy: The role of loneliness, anxiety, and maternal support.

Background: The current study aimed at assessing the levels of perinatal depression (i.e., both antenatal and postnatal) during the fourth wave of the COVID-19 outbreak in a group of Italian women, as well as to evaluate the role of loneliness, anxiety, and lack of maternal support in cumulatively predicting perinatal depression. Methods: A cross-sectional study was conducted with 200 Italian women recruited during a peak of the COVID-19 pandemic in Italy (i.e., from September to December 2021) from a single prenatal clinic in Southern Italy. A non-parametric binomial test was conducted to assess whether the perinatal depression frequencies of the current sample differed from those found in a pre-Covid reference group. Additionally, hierarchical multiple linear regression analyses assessing whether loneliness, anxiety, and maternal support affected women's perinatal depression were also conducted. Results: The general prevalence of perinatal depression was significantly higher in participants recruited during the fourth wave of the COVID-19 pandemic compared to the pre-Covid reference group (29% vs. 9.2%). However, results showed that, contrary to postnatal depression (18.2% vs. 19.9%), only the prevalence of antenatal depression was significantly higher compared to the pre-Covid reference group (39.6% vs. 6.4%). Furthermore, loneliness and anxiety, but not maternal support, were associated with higher levels of PD. Limitations: Limitations concerned the cross-sectional nature of the study and the relatively small sample size. Conclusions: This study sheds light on the need to address perinatal mental health of women during major stressful events, such as the COVID-19 pandemic.

Activity restriction for women with arrested preterm labor: a randomized controlled trial.

BACKGROUND: In the past, some pregnant women have been recommended to be in activity restriction because of the presumed increased risk of preterm birth due to the increased release of catecholamines, which might stimulate myometrial activity, during exercise and aerobic activity. OBJECTIVE: This study aimed to test the hypothesis that in women with singleton pregnancy and arrested preterm labor, activity restriction would reduce the rate of preterm birth at <37 weeks of gestation. STUDY DESIGN: This was a parallel-group nonblinded randomized trial conducted at a single center in Italy. Eligible patients were those with a diagnosis of arrested preterm labor, defined as not delivering after 48 hours of hospitalization for threatened preterm labor, with transvaginal ultrasound cervical length ≤25 mm, no other symptoms of possible uterine contractions, and cervical dilatation <3 cm at pelvic examination. Inclusion criteria were singleton pregnancies between 24 0/7 and 33 6/7 weeks of gestation. Participants were randomized in a 1:1 ratio to either activity restriction at the time of discharge or no activity restriction. Women in the intervention group were recommended activity restriction, defined as the following: pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity. The primary endpoint was preterm birth at <37 weeks of gestation. RESULTS: A total of 120 participants were included in the trial; 60 patients were enrolled in the activity restriction group and 60 in the control group. Preterm birth at <37 weeks of gestation occurred in 15 of 60 women (25.0%) in the activity restriction group and 23 of 60 women (38.3%) in the control group (relative risk, 0.65; 95% confidence interval, 0.38-1.12). There was no significant between-group difference in the incidence of preterm birth at <32 weeks and in neonatal outcomes, but the trial was not powered for these outcomes. CONCLUSION: In singleton gestations with arrested preterm labor, activity restriction, including pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity, does not result in a lower rate of preterm birth at <37 weeks. Given the evidence on the lack of benefits, use of activity restriction in this population should be discouraged.

Characteristics of Placental Histopathology in Women with Uncomplicated Pregnancies Affected by SARS-CoV-2 Infection at the Time of Delivery: A Single-Center Experience.

The aim of this study was, firstly, to analyze the histopathological characteristics of placentas in women with uneventful pregnancies and affected by COVID-19 at the time of delivery; and secondly, to correlate histological findings to maternal and neonatal characteristics. In our single-center prospective observational study, 46 placentas from term uncomplicated singleton pregnancies of patients with a documented SARS-CoV-2 infection at the time of delivery underwent histological examination. Despite a normal feto-maternal outcome, most of the placentas (82.6%) presented signs of maternal vascular malperfusion, while features of fetal vascular malperfusion were found in 54% of cases. No correlation was detected between maternal and neonatal characteristics and the severity of blood circulation disease, and abnormal findings were also described in asymptomatic patients. Moreover, we did not find any maternal symptoms or clinical details allowing for the prediction of abnormal placental findings in pregnancy complicated by COVID-19 infection. Our results suggest that SARS-CoV-2 infection during pregnancy could lead to acute placental dysfunction.

Hands-on vs hands-off technique for the prevention of perineal injury: a randomized clinical trial.

BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION: In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations.

Vaginal progesterone compared with intramuscular 17-alpha-hydroxyprogesterone caproate for prevention of recurrent preterm birth in singleton gestations: a systematic review and meta-analysis.

OBJECTIVE: 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. DATA SOURCES: 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. STUDY ELIGIBILITY CRITERIA: 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. METHODS: The primary outcome was preterm birth <34 weeks' gestation. The summary measures were reported as relative risks with 95% confidence intervals. RESULTS: 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 at <34 weeks (14.7% vs 19.9%; relative risk, 0.74; 95% confidence interval, 0.57-0.96), preterm birth at <37 weeks (36.0% vs 46.6%; relative risk, 0.76; 95% confidence interval, 0.69-0.85), and preterm birth at <32 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 at <28 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 at <34 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). CONCLUSION: Overall, vaginal progesterone was superior to 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth at <34 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.

The Effectiveness of Neroli Essential Oil in Relieving Anxiety and Perceived Pain in Women during Labor: A Randomized Controlled Trial.

Childbirth is a stressful and physically painful event in a woman's life and aromatherapy is one of the most used non-pharmacological methods that is effective in reducing anxiety and perceived pain. This randomized controlled study aimed at determining the effect of neroli oil aromatherapy on anxiety and pain intensity perception in 88 women during labor, randomly assigned to either an intervention group (n = 44) or control group (n = 44). Anxiety and perceived pain were assessed through the visual analogue scale during the latent, early, and late active phases of labor. Data analyses included the t-test, Chi-square test, and repeated measures ANOVA. Perceived pain and anxiety in the group receiving aromatherapy were significantly lower than in the control group at all stages of labor (p < 0.05). Specifically, as the labor progressed, pain and anxiety increased in all participants, but the increase was milder in the experimental group than in the control group. The multiparas showed higher average anxiety scores, but not perceived pain, than the primiparas in all phases of labor (p < 0.05). Ultimately, neroli oil aromatherapy during labor can be used as an alternative tool to relieve anxiety and perceived pain in women during all stages of labor.

Cervical elastography using E-cervix for prediction of preterm birth in singleton pregnancies with threatened preterm labor.

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 <25 mm, and were admitted for true PLT. Out of the 53 women with cervical length ≥25 mm, 40 (75.5%) were discharged, and 13 (24.5%) were admitted. Women with threatened PTL but without true PTL, had significantly higher HR compared to those with true PTL (49.0 ± 20.9% versus 34.8 ± 19.6%; p < .01), and significantly lower stiffness of cervical IOS and EOS. Women who delivered preterm had significantly lower HR compared to those who did not delivery preterm, in overall cohort, and in the subset of only women with true PTL. Incidences of HR < 50% and <35% were statistically significantly higher in women who delivered preterm compared to those who did not (p < .01). CONCLUSIONS: Cervical elastography with E-cervix may be useful for the assessment of women presenting to obstetrics triage for threatened PTL. Women with low HR, especially with HR less than 50 or 35%, are at increased risk of PTB. CONDENSATION: Women who delivered preterm had significantly lower HR compared to those who did not delivery preterm and significantly lower IOS and EOS, in overall cohort, and in the subset of women with true PTL. Incidences of HR < 50% and <35% were statistically significantly higher in women who delivered preterm compared to those who did not (p < .01). KEY MESSAGE: Cervical elastography with E-cervix may be useful for the assessment of women presenting to obstetrics triage for threatened PTL.

Obstetric violence in a group of Italian women: socio-demographic predictors and effects on mental health.

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.

Obstetric A&E unit admission and hospitalization for obstetrical management during COVID-19 pandemic in a third-level hospital of southern Italy.

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 < 0.0001). Mean ± SD of patients monthly hospitalized to our department was 194 ± 19.1 in the year 2020, 213.7 ± 4.7 in 2019, with a mean difference of - 19.7 (95% CI - 23.8 to - 15.6; p < 0.0001). 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.

Anthracyclines Strike Back: Rediscovering Non-Pegylated Liposomal Doxorubicin in Current Therapeutic Scenarios of Breast Cancer.

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.

Poly (ADP-ribose) polymerase inhibitors in solid tumours: Systematic review and meta-analysis.

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.

Childbirth Care among SARS-CoV-2 Positive Women in Italy.

The new coronavirus emergency spread to Italy when little was known about the infection's impact on mothers and newborns. This study aims to describe the extent to which clinical practice has protected childbirth physiology and preserved the mother-child bond during the first wave of the pandemic in Italy. A national population-based prospective cohort study was performed enrolling women with confirmed SARS-CoV-2 infection admitted for childbirth to any Italian hospital from 25 February to 31 July 2020. All cases were prospectively notified, and information on peripartum care (mother-newborn separation, skin-to-skin contact, breastfeeding, and rooming-in) and maternal and perinatal outcomes were collected in a structured form and entered in a web-based secure system. The paper describes a cohort of 525 SARS-CoV-2 positive women who gave birth. At hospital admission, 44.8% of the cohort was asymptomatic. At delivery, 51.9% of the mothers had a birth support person in the delivery room; the average caesarean section rate of 33.7% remained stable compared to the national figure. On average, 39.0% of mothers were separated from their newborns at birth, 26.6% practised skin-to-skin, 72.1% roomed in with their babies, and 79.6% of the infants received their mother's milk. The infants separated and not separated from their SARS-CoV-2 positive mothers both had good outcomes. At the beginning of the pandemic, childbirth raised awareness and concern due to limited available evidence and led to "better safe than sorry" care choices. An improvement of the peripartum care indicators was observed over time.