Epidemiology and Prevention of Congenital HCMV in Immune Mothers. Congenital HCMV Infection Lombardy
Part 1. Epidemiologic study. To investigate incidence and outcome of congenital infection in immune mothers, clinical records of pregnant women are reviewed for HCMV serostatus at ≤ 13 weeks' gestation. Women with HCMV serology compatible with a remote infection are asked to participate in the study. Consenting women are given a pre-stamped, pre-addressed envelope containing a swab to collect newborn's saliva. Envelopes are sent by courier to a centralized diagnostic facility for HCMV testing. Women can also be enrolled at delivery, provided that the woman has records of presence of virus-specific IgG and absence of IgM early during gestation(or in a previous pregnancy) or, in case of unknown serostatus, a sample of serum/plasma stored at ≤ 13 weeks' gestation is available for retrospective antibody testing (retrospective part of the epidemiology study). Part 1. Nested study. A subset of IgG pos IgM neg women selected among those enrolled at ≤13 weeks' gestation in the epidemiology study are included in a nested study. These women are monitored at enrolment, 20, 30 weeks of gestation and at delivery by prospective determination of HCMV DNA excretion in different bodily fluids. In DNA-positive specimens selected HCMV genes will be sequenced. Part 2. Prevention study. To assess the effectiveness of hygiene measures for prevention of congenital infection HCMV seropositive pregnant women are enrolled at ≤ 13 weeks' gestation. Part 2 starts when enrolment of Part 1 is completed. In practice, part 2 is a continuation of part 1 with the only addition of delivering hygiene information at enrolment. Part 2 will not be performed in case congenital infection rate in Part 1 is <0.4% and clear maternal risk factor for intrauterine transmission cannot be identified at interim analysis (i.e. after examination of 5000 newborns). In case HCMV DNA is detected in newborn's saliva, a urine sample is obtained for confirmation of congenital infection. Infants with documented congenital infection are clinically assessed at the time of diagnosis (for Part 1 and 2) and at one year of age (Part 1 only).
Phase
N/ASpan
174 weeksSponsor
Foundation IRCCS San Matteo HospitalCarate Brianza
Recruiting
Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group
Multicenter prospective cohort observational study. The enrollment period will be 5 years. An additional 4 months will be required to allow the last enrolled patients to complete the 120-day follow-up. It is estimated to enroll a total of 7,000 patients. To facilitate the participation in the study of non-university or IRCCS assistance departments, two methods of data collection will be possible: - High intensity: continuous data collection for the whole period of the study on all the incident cases - Low intensity: data collection once a year on incident cases over a continuous period of 1 month, with a reduced number of variables. The choice of the level of intensity with regard to the data collection method will take place on a voluntary basis (each OU will actually choose the type of speed with which it intends to collaborate in the project, after communicating to the steering committee and to the biostatisticians of the study)
Phase
N/ASpan
268 weeksSponsor
University of Milano BicoccaCarate Brianza
Recruiting
Mode of Delivery in Women With Low-lying Placenta
This is a new protocol to evaluate the mode of birth in women with a low-lying placenta. In particular, we intend to propose a vaginal birth in women having a low-lying placenta with a distance between the inferior placental edge and the internal cervical os, called internal-os-distance (IOD) of > 5 mm, as assessed in the late III trimester using transvaginal sonography. Duration of the study: - Duration of the study: 54 months - Duration of enrollment: 42 months - Duration of follow-up completion of enrolled cases: 6 months - Duration of data analysis: 6 months Study Design: During the II trimester scan, all women presenting a placenta located in the lower uterine segment will undergo evaluation by Transvaginal Sonography (TVS). If a placenta previa or a low-lying placenta will be confirmed, the woman will be recruited and asked to participate in our study, by signing a written informed consent. In addition women attending the Maternity Triage with vaginal bleeding at < 316/7 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery will be asked to participate and will be recruited after signing the informed consent. An expert Obstetrician will perform the TVS as scheduled, after inviting the woman to void. The assessment will include: - the measurement of the IOD (first caliper on the internal cervical os and second caliper on the inferior placental edge). In case of a marginal sinus, the distance between the internal cervical os and the marginal sinus will also be assessed; - the cervical length (defined as shortened if ≤25 mm); - the placental edge thickness, measured within 1 cm from the meeting point between the basal and the chorionic plate. The placental edge will be considered "thick" if > 1cm or if the angle is >45°. All women with a resolution of a previa or low-lying placenta will be assessed in accordance with the protocol of each participating Maternity Unit, including a scan assessment at 38-39 weeks of gestation or within 28 days from the due date. Calculation of sample size / power: Considering that the incidence of previa and low-lying placenta is approximately 2% at the II trimester scan and 0.4% at birth, and assuming a C.I. of 19% in the probability of vaginal birth in women with low-lying placenta/resolved low-lying (> 20 mm), 27 women will be needed for each participating Maternity Unit at the late III trimester scan. Anticipating a 10% drop out, 30 women will be needed to achieve a 95% statistical power to identify a clinically relevant difference in the rate of vaginal birth. This leads to the need of recruiting 150 women at the II trimester scan. CRF and data management: All data will be recorded through CRF provided by the promoter center and the database will be based on Microsoft Excel. A sample of about 20-30 patients for each enrollment center is necessary to have a statistical power of 95% in detecting a clinically relevant difference in outcomes in the various study groups. Analysis plan: Descriptive statistics will be performed for all variables evaluated in the study population. Variables will be described by mean and standard deviation if normally distributed, otherwise by median and interquantile range; proportions will be used for categorical variables. The quantitative variables, among the study groups defined by the IOD at the last TVS, will be compared by parametric and non-parametric tests, whereas the categorical variables will be compared using Pearson's chi2 test (Fisher exact test where appropriate). The analyses for the primary outcome measure will be performed among women admitted to labor. A multivariate analysis will be conducted to assess the association between obstetric variables and vaginal birth. A p-value<0.05 will be considered significant.
Phase
N/ASpan
235 weeksSponsor
University of Milano BicoccaCarate Brianza
Recruiting
Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Italy witnessed a rapid and uncontrolled spread of the infection after March 2020, and a worrisome increasing number of related deaths. The need for increased capacity for COVID-19 patients required elective activities to be drastically reduced or canceled. The unprecedented stress on the healthcare system has caused the reduction of the elective surgery and the cancer screening programs during the last 2 years. Studies predicting harmful impact of the COVID-19 pandemic on cancer care have been already published. However, it has not been proved whether the potential delay of screening, diagnosis and treatment could have a measurable effect on patients undergoing surgery for colorectal cancer in the COVID-19 era. The aim of the study is therefore to compare the 30-day perioperative and oncologic outcomes between patients undergoing surgery for cancer of the colon and rectum between January 2020 and December 2021 (study group) and those who had surgery for colorectal cancer between January 2018 and December 2019 (Control Group), in order to identify: - any change in the distribution of the histological stage (primary aim) - any change in the rate of palliative surgery (primary aim) - any change in the rate of non-radical surgery (R1 or R2 resection) ( primary aim) - any change in the rate of 30-day postoperative complications (secondary outcome) Anonimyzed data will be retrospectively collected on a RedCap platform hosted on the servers of the Alma Mater Studiorum University of Bologna. The variables included demographic characteristics, comorbidities, details of the disease at the diagnosis, details of the neoadjuvant therapy, perioperative variables and 30-day postoperative follow-up variables.
Phase
N/ASpan
82 weeksSponsor
University of BolognaCarate Brianza
Recruiting