Pregnancy outcomes in Italy during COVID-19 pandemic: a population-based cohort study.

OBJECTIVE: To compare the estimates of preterm birth (PTB; 22-36 weeks gestational age, GA) and stillbirth rates during COVID-19 pandemic in Italy with those recorded in the three previous years. DESIGN: A population-based cohort study of liveborn and stillborn infants was conducted using data from Regional Health Systems and comparing the pandemic period (March 1st , 2020-March 31st , 2021, N= 362,129) to an historical period (January 2017- February 2020, N=1,117,172). The cohort covered 84.3% of the births in Italy. METHODS: Poisson regressions were run in each Region and meta-analyses were performed centrally. We used an interrupted time series regression analysis to study the trend of preterm births from 2017 to 2021. MAIN OUTCOME MEASURES: The primary outcomes were PTB and stillbirths. Secondary outcomes were late PTB (32-36 weeks' GA), very PTB (<32 weeks' GA), and extremely PTB (<28 weeks' GA), overall and stratified into singleton and multiples. RESULTS: The pandemic period compared with the historical one was associated with a reduced risk for PTB (Risk Ratio: 0.91; 95% Confidence Interval, CI: 0.88, 0.93), late PTB (0.91; 0.88, 0.94), very PTB (0.88; 0.84, 0.91), and extremely PTB (0.88; 0.82, 0.95). In multiples, point estimates were not very different, but had wider CIs. No association was found for stillbirths (1.01; 0.90, 1.13). A linear decreasing trend in PTB rate was present in the historical period, with a further reduction after the lockdown. CONCLUSIONS: We demonstrated a decrease in PTB rate after the introduction of COVID-19 restriction measures, without an increase in stillbirths.

Stillbirth occurrence during COVID-19 pandemic: a population-based prospective study.

OBJECTIVES: Data collected worldwide on stillbirth (SB) rates during the Covid-19 pandemic are contradictory. Variations may be due to methodological differences or population characteristics. The aim of the study is to assess the changes in SB rate, risk factors, causes of death and quality of antenatal care during the pandemic compared to the control periods. METHODS: This prospective study is based on the information collected by the Emilia-Romagna Surveillance system database. We conducted a descriptive analysis of SB rate, risk factors, causes of death and quality of cares, comparing data of the pandemic (March 2020-June 2021) with the 16 months before. RESULTS: During the pandemic, the SB rate was 3.45/1,000 births, a value in line with the rates of previous control periods. Neonatal weight >90th centile was the only risk factor for SB that significantly changed during the pandemic (2.2% vs. 8.0%; p-value: 0.024). No significant differences were found in the distribution of the causes of death groups. Concerning quality of antenatal cares, cases evaluated with suboptimal care (5.2%) did not change significantly compared to the control period (12.0%), as well as the cases with less than recommended obstetric (12.6% vs. 14%) and ultrasound evaluations (0% vs. 2.7%). CONCLUSIONS: During the COVID-19 pandemic, no significant differences in SB rates were found in an area that maintained an adequate level of antenatal care. Thus, eventual associations between SB rate and the COVID-19 infection are explained by an indirect impact of the virus, rather than its direct effect.

[The preparedness of the Italian obstetric surveillance system in the response to the emergency of the SARS-CoV-2 pandemic: methodological aspects of a population-based study]. / La preparedness dell'Italian obstetric surveillance system in occasione della pandemia da SARS-CoV-2: aspetti metodologici di uno studio di popolazione.

This paper aims to describe the Italian obstetric surveillance system (ItOSS) preparedness as an element for a timely response to the new Coronavirus pandemic. ItOSS is a surveillance network that has been collecting data on maternal mortality and conducting population studies on obstetric near misses since 2013. At the beginning of the pandemic, ItOSS launched a new population-based project to monitor SARS-CoV-2 infection during pregnancy and post-partum and promptly give back information useful to clinicians and decision-makers. All the regions and autonomous provinces, for a total of 289 birth units (PN), joined the study. Data relating to pregnant or post-partum women with a confirmed SARS-CoV-2 infection diagnosis addressing the maternities for outpatient visits or hospitalization were collected. The project methodology entails that each participating maternity reports the cases to ItOSS uploading data through an open-source platform. The on-line form includes sociodemographic and clinical data and maternal-neonatal outcomes. Biological samples to detect possible vertical transmission are also collected voluntarily. A total of 534 incident cases were reported from February 25th to July 10th 2020; 7 regions also collected biological samples for 227 cases; data collection is still ongoing.A preliminary analysis of the first 146 SARS-CoV-2 positive women who gave birth between February 25th to April 22nd shows an incidence rate of the infection equal to 2.1/1,000 in Italy and 6.9/1,000 in the Lombardy Region (Northern Italy). The brief time needed to setting up and operating the project, the national coverage, the adoption of shared tools for data collection, the quality and completeness of the information collected show how the availability of active networks like ItOSS represents a crucial element to hold a high level of preparedness in case of a health emergency.

Short-term and long-term effects of tibolone in postmenopausal women.

BACKGROUND: Tibolone is a synthetic steroid used for the treatment of menopausal symptoms, on the basis of short-term data suggesting its efficacy. We considered the balance between the benefits and risks of tibolone. OBJECTIVES: To evaluate the effectiveness and safety of tibolone for treatment of postmenopausal and perimenopausal women. SEARCH METHODS: In October 2015, we searched the Gynaecology and Fertility Group (CGF) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and PsycINFO (from inception), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and clinicaltrials.gov. We checked the reference lists in articles retrieved. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing tibolone versus placebo, oestrogens and/or combined hormone therapy (HT) in postmenopausal and perimenopausal women. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures of The Cochrane Collaboration. Primary outcomes were vasomotor symptoms, unscheduled vaginal bleeding and long-term adverse events. We evaluated safety outcomes and bleeding in studies including women either with or without menopausal symptoms. MAIN RESULTS: We included 46 RCTs (19,976 women). Most RCTs evaluated tibolone for treating menopausal vasomotor symptoms. Some had other objectives, such as assessment of bleeding patterns, endometrial safety, bone health, sexuality and safety in women with a history of breast cancer. Two included women with uterine leiomyoma or lupus erythematosus. Tibolone versus placebo Vasomotor symptomsTibolone was more effective than placebo (standard mean difference (SMD) -0.99, 95% confidence interval (CI) -1.10 to -0.89; seven RCTs; 1657 women; moderate-quality evidence), but removing trials at high risk of attrition bias attenuated this effect (SMD -0.61, 95% CI -0.73 to -0.49; odds ratio (OR) 0.33, 85% CI 0.27 to 0.41). This suggests that if 67% of women taking placebo experience vasomotor symptoms, between 35% and 45% of women taking tibolone will do so. Unscheduled bleedingTibolone was associated with greater likelihood of bleeding (OR 2.79, 95% CI 2.10 to 3.70; nine RCTs; 7814 women; I2 = 43%; moderate-quality evidence). This suggests that if 18% of women taking placebo experience unscheduled bleeding, between 31% and 44% of women taking tibolone will do so. Long-term adverse eventsMost of the studies reporting these outcomes provided follow-up of two to three years (range three months to three years). Breast cancerWe found no evidence of differences between groups among women with no history of breast cancer (OR 0.52, 95% CI 0.21 to 1.25; four RCTs; 5500 women; I2= 17%; very low-quality evidence). Among women with a history of breast cancer, tibolone was associated with increased risk (OR 1.5, 95% CI 1.21 to 1.85; two RCTs; 3165 women; moderate-quality evidence). Cerebrovascular eventsWe found no conclusive evidence of differences between groups in cerebrovascular events (OR 1.74, 95% CI 0.99 to 3.04; four RCTs; 7930 women; I2 = 0%; very low-quality evidence). We obtained most data from a single RCT (n = 4506) of osteoporotic women aged 60 to 85 years, which was stopped prematurely for increased risk of stroke. Other outcomesEvidence on other outcomes was of low or very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:• Endometrial cancer: OR 2.04, 95% CI 0.79 to 5.24; nine RCTs; 8504 women; I2 = 0%.• Cardiovascular events: OR 1.38, 95% CI 0.84 to 2.27; four RCTs; 8401 women; I2 = 0%.• Venous thromboembolic events: OR 0.85, 95% CI 0.37 to 1.97; 9176 women; I2 = 0%.• Mortality from any cause: OR 1.06, 95% CI 0.79 to 1.41; four RCTs; 8242 women; I2 = 0%. Tibolone versus combined HT Vasomotor symptomsCombined HT was more effective than tibolone (SMD 0.17, 95% CI 0.06 to 0.28; OR 1.36, 95% CI 1.11 to 1.66; nine studies; 1336 women; moderate-quality evidence). This result was robust to a sensitivity analysis that excluded trials with high risk of attrition bias, suggesting a slightly greater disadvantage of tibolone (SMD 0.25, 95% CI 0.09 to 0.41; OR 1.57, 95% CI 1.18 to 2.10). This suggests that if 7% of women taking combined HT experience vasomotor symptoms, between 8% and 14% of women taking tibolone will do so. Unscheduled bleedingTibolone was associated with a lower rate of bleeding (OR 0.32, 95% CI 0.24 to 0.41; 16 RCTs; 6438 women; I2 = 72%; moderate-quality evidence). This suggests that if 47% of women taking combined HT experience unscheduled bleeding, between 18% and 27% of women taking tibolone will do so. Long-term adverse eventsMost studies reporting these outcomes provided follow-up of two to three years (range three months to three years). Evidence was of very low quality, with no clear evidence of any differences between the groups. Effect estimates were as follows:• Endometrial cancer: OR 1.47, 95% CI 0.23 to 9.33; five RCTs; 3689 women; I2 = 0%.• Breast cancer: OR 1.69, 95% CI 0.78 to 3.67; five RCTs; 4835 women; I2 = 0%.• Venous thromboembolic events: OR 0.44, 95% CI 0.09 to 2.14; four RCTs; 4529 women; I2 = 0%.• Cardiovascular events: OR 0.63, 95% CI 0.24 to 1.66; two RCTs; 3794 women; I2 = 0%.• Cerebrovascular events: OR 0.76, 95% CI 0.16 to 3.66; four RCTs; 4562 women; I2 = 0%.• Mortality from any cause: only one event reported (two RCTs; 970 women). AUTHORS' CONCLUSIONS: Moderate-quality evidence suggests that tibolone is more effective than placebo but less effective than HT in reducing menopausal vasomotor symptoms, and that tibolone is associated with a higher rate of unscheduled bleeding than placebo but with a lower rate than HT.Compared with placebo, tibolone increases recurrent breast cancer rates in women with a history of breast cancer, and may increase stroke rates in women over 60 years of age. No evidence indicates that tibolone increases the risk of other long-term adverse events, or that it differs from HT with respect to long-term safety.Much of the evidence was of low or very low quality. Limitations included high risk of bias and imprecision. Most studies were financed by drug manufacturers or failed to disclose their funding source.

Does age modify the relationship between adherence to secondary prevention medications and mortality after acute myocardial infarction? A nested case-control study.

PURPOSE: Clinical trials have shown that evidence-based secondary prevention medications reduce mortality after acute myocardial infarction (AMI). Yet, these medications are generally underused in daily practice, and older people are often excluded from drug trials. The purpose of this study was to examine whether the relationship between adherence to evidence-based drugs and post-AMI mortality varies with increasing age. METHODS: The study population was defined as all residents in the Local Health Authority of Bologna (Italy) hospitalized for AMI between January 1, 2008 and June 30, 2011, and followed up until December 31, 2012. Medication adherence was calculated as the proportion of days covered (PDC) for filled prescriptions of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, ß-blockers, antiplatelet drugs, and statins; patients were classified as adherent (PDC ≥75 %) or nonadherent (PDC <75 %). We used incidence density sampling, and the moderating effect of age on the relationship between adherence and mortality was investigated through conditional multiple logistic regression analysis. RESULTS: The study population comprised 3963 patients. During the 5-year study period, 1085 deaths (27.4 %) were observed. For both younger and older patients, adherence to polytherapy (three or four medications) was associated with lower mortality (adj. rate ratio = 0.41; P < 0.001). A significant inverse relationship was found between adherence to each of the four medications and mortality, although the risk reduction associated with antiplatelet therapy declined after the age of 70-75. CONCLUSIONS: The beneficial effect of evidence-based polytherapy on mortality following AMI is observed also in older populations. Nevertheless, the risk-benefit ratio associated with antiplatelet therapy is less favorable with increasing age.

[Organisational determinants of adherence to secondary prevention medications after acute myocardial infarction]. / Determinanti organizzativi e assistenziali dell'aderenza alle terapie di prevenzione secondaria nei pazienti con infarto miocardico acuto.

OBJECTIVES: to identify organisational determinants of adherence to evidence-based drug treatments after acute myocardial infarction (AMI), under the hypothesis that low adherence is associated with higher mortality and risk of reinfarction. In particular, we investigated the effect of group vs. single handed practice and multi-professional practice characteristics on patients' adherence to polytherapy after AMI. DESIGN: retrospective cohort study. SETTING AND PARTICIPANTS: residents in the Local Health Authority of Bologna (Italy) who were discharged from any Italian hospital between 2008 and 2011 with a diagnosis of AMI, and followed-up for a year. MAIN OUTCOME MEASURES: adherence to at least three out of the four drug therapies recommended for secondary prevention of AMI (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, ß-blockers, antiplatelet agents, statins). Patients who had at least 80% of days of follow-up covered by drug doses were considered adherent. RESULTS: of the 4,828 post-AMI patients, 31.6% were adherent to polytherapy. General practice characteristics were unrelated to adherence, whereas discharge from cardiology hospital wards was significantly associated with higher patients' adherence (OR 1.97; 95%CI 1.56-2.48). CONCLUSION: general practice organisational models are not associated with higher adherence to evidence-based medications after AMI, whereas cardiologists seem to play a key role in improving patient adherence to polytherapy. Healthcare delivery models should be designed; in them, general practitioners are responsible for the provision of patient-centred care pathways and for care co-ordination with other primary care professionals and specialists, and take an advocacy role for the patient when needed.

Risk factors for stillbirth at term: an Italian area-based, prospective cohort study.

BACKGROUND: Stillbirth at term has great emotional impact on both parents and professionals. In developed countries, efforts to identify risk factors are mandatory to plan area-specific prevention strategies. OBJECTIVE: The aim of the study was to identify independent risk factors that contribute to stillbirth at 37 weeks' gestation or later. STUDY DESIGN: This was an area-based, prospective cohort study on pregnancy at term with enrolled from 2014 to 2021 in Emilia-Romagna, a north Italian region. Data were retrieved from both birth certificates and the Stillbirth Surveillance system database. To identify independent risk factors, a multivariate analysis using logistic regression was performed. A descriptive analysis of the causes of stillbirth is also reported. RESULTS: In the observation period, 246,437 babies born at term (including 260 stillbirths, giving a rate of 1.06/1000) were considered. The risk factors independently associated with stillbirth were small for gestational age babies (odds ratio, 2.58; 95% confidence interval, 1.88-3.53), pregnancy achieved though fertility treatments (odds ratio, 2.01; 95% confidence interval, 1.15-3.51), and delayed access to pregnancy services (odds ratio, 1.56; 95% confidence interval, 1.10-2.22). In multipara, the presence of a previous stillbirth (odds ratio, 3.91; 95% confidence interval, 1.98-7.72) was also associated with an increased risk for recurrence. Early- rather than late-term was an additional risk factor. The most frequent causes of death were placental and cord disorders (61/260 and 56/260, respectively). However, 28.1% of cases remain unexplained. CONCLUSION: The risks for stillbirth at term are known early in pregnancy or could be identified through tailored antenatal management, allowing effective preventive strategies to reduce preventable cases.

Short and long term effects of tibolone in postmenopausal women.

BACKGROUND: Tibolone is an option available for the treatment of menopausal symptoms, based on short-term data on its efficacy. However, there is a need to consider the balance between the benefits and risks of tibolone as there are concerns about breast and endometrial cancer as well as stroke. OBJECTIVES: To evaluate the effectiveness and safety of tibolone in treating postmenopausal women. SEARCH METHODS: We searched the Cochrane Menstrual Disorders and Subfertility Group (MDSG) Specialised Register (19 April 2011), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, 2nd Quarter), MEDLINE (from inception to 19 April 2011), EMBASE (1980 to week 3 April 2011), PsycINFO (1806 to week 3 April 2011), Clinical Trials.gov (30 April 2011). Individual researchers and the current manufacturer of tibolone were contacted to identify unpublished and ongoing trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared tibolone versus placebo, estrogens or combined hormone replacement therapy (HT) by assessing the percentage of women with menopausal symptoms, the severity of those symptoms and the occurrence of safety outcomes in postmenopausal women. DATA COLLECTION AND ANALYSIS: Four review authors independently extracted information from the articles, resolving discrepancies by consensus. All outcomes studied were dichotomous. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using the random-effects model. Heterogeneity of studies was taken into account before deciding to combine the data. MAIN RESULTS: When compared to placebo, tibolone was more effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 847; OR 0.42, 95% CI 0.25 to 0.69), although only the 2.5 mg/day dose of tibolone was significantly better than placebo; but with increased vaginal bleeding (seven RCTs, n = 7462; OR 2.75, 95% CI 1.99 to 3.80). When compared to equipotent doses of combined HT, tibolone reduced vaginal bleeding (15 RCTs, n = 6342; OR 0.32, 95% CI 0.24 to 0.42) but was less effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 545; OR 4.16, 95% CI 1.50 to 11.58).As for long term safety, two major RCTs of tibolone versus placebo provided the most relevant data. An RCT of 3098 women with breast cancer and menopausal symptoms was halted after 3.1 years because of increased tumour recurrence (OR 1.50; 95% CI 1.21 to 1.85). However, in another RCT that selected osteoporotic women with negative mammograms (n = 4506) tibolone was associated with a reduction in breast cancer compared to placebo after 2.8 years (OR 0.32, 95% CI 0.13 to 0.79) although the trial was not specifically designed to assess that outcome and the number of overall events was low. In the same RCT, an excess risk of stroke was observed (OR 2.18, 95% CI 1.12 to 4.21). There was no clear evidence of a tibolone effect on endometrial cancer compared with placebo given the low number of events (seven RCTs, n = 8152; OR 1.98, 95% CI 0.73 to 5.32).There was no evidence of a difference in long term safety between tibolone and combined HT. AUTHORS' CONCLUSIONS: Tibolone, used at the daily dose of 2.5 mg, may be less effective than combined HT in alleviating menopausal symptoms although it reduced the incidence of vaginal bleeding. There was evidence that treatment with combined HT was more effective in managing menopausal symptoms than was tibolone. Available data on the long term safety of tibolone is concerning given the increase in the risk of breast cancer in women who had already suffered from breast cancer in the past and in a separate trial the increase in the risk of stroke in women whose mean age was over 60 years. Similar concerns may exist for estroprogestins but their overall benefit-risk profile is better known and is more directly related to women with menopausal symptoms.

Implementation of guidelines about women with previous cesarean section through educational/motivational interventions.

OBJECTIVE: To investigate the effect of a quality improvement project with an educational/motivational intervention in northern Italy on the implementation of the trial of labor after cesarean section (CS). METHOD: A pre-post study design was used. Every birth center (n = 23) of the Emilia-Romagna region was included. Gynecologist opinion leaders were first trained about Italian CS recommendations. Barriers to implementation were discussed and shared. Educational/motivational interventions were implemented. Data of multipara with previous CS, with a single, cephalic pregnancy at term, were collected during two periods, before (2012-2014) and after (2017-2019) the intervention (2015-2016). The primary outcome was the rate of vaginal birth after CS (VBAC) and perinatal outcomes. RESULTS: A total of 20 496 women were included. The VBAC rate increased from 18.1% to 23.1% after intervention (P < 0.001). The likelihood of VBAC-adjusted for age 40 years or older, Caucasian, body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) at least 30, previous vaginal delivery, and labor induction-was increased by the intervention by 42% (odds ratio 1.42, 95% confidence interval 1.31-1.54). Neonatal well-being was improved by intervention; neonates requiring resuscitation decreased from 2.1% to 1.6% (P = 0.001). CONCLUSION: Educating and motivating gynecologists toward the trial of labor after CS is worth pursuing. Health quality improvement is demonstrated by increased VBAC even improving neonatal well-being.

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.

Neurodevelopmental Trajectories of Preterm Infants of Italian Native-Born and Migrant Mothers and Role of Neonatal Feeding.

There is evidence that preterm infants of migrant mothers are at a higher risk of adverse perinatal outcomes than those of native-born mothers, and that human milk feeding is beneficial to infants' neurodevelopment. Using the United Nations Human Development Index (HDI) to classify mother's country of origin, we investigated whether type of neonatal feeding (human milk vs. mixed milk vs. exclusive formula milk) affected preterm newborn neurodevelopment varying across different HDI categories (Italian native-born vs. high HDI migrant vs. low HDI migrant) up to 2 years of age. Neurodevelopment of 530 infants born in Italy at ≤32 weeks of gestational age and/or weighing <1500 g was measured at 3-, 6-, 9-, 12-, 18-, and 24-months corrected age (CA) using the revised Griffiths Mental Development Scale 0-2 years. The trajectories of the general developmental quotient and its five subscales were estimated using mixed models. At 24-months CA only preterm infants of low HDI migrant mothers and fed exclusive formula milk showed moderate neurodevelopment impairment, with lower developmental trajectories of eye-hand coordination, performance, and personal-social abilities. Migrant mothers from low HDI countries and their preterm infants should be targeted by specific programs supporting maternal environment, infant development, and human or mixed milk neonatal feeding. Future research should focus on a deeper understanding of the mechanisms through which type of feeding and mother migrant conditions interact in influencing preterm infants' neurodevelopment.

[Computerized medical records in monitoring hypertension. Longitudinal and horizontal evaluation of 25 general practitioners in a primary care setting of Modena, Italy]. / Monitoraggio del paziente iperteso attraverso l'utilizzo della cartella clinica informatizzata. Valutazione longitudinale e trasversale dell'attività di 25 Medici di Medicina Generale della azienda Unità Sanitaria Locale di Modena.

This study aims at evaluating the effectiveness of a computerized-based Clinical Record in monitoring hypertension in a Primary Care Setting. Blood pressure (BP) recording increased by 62% to 70% in the years 2004 to 2006. No improvement, however, was noticeable in the achievement of gold-standard targets in BP control (62% in all period). At the end of 2006 BP was recorded in 65% of patients. Among them, 2/3 of the non diabetics reached < 140/90 mmHg standard, while only 23% of diabetics reached < 130/80 mmHg standard. In conclusion, using a computerized clinical record appears not to be sufficient to obtain good clinical performances, yet it is a necessary first step to clinical audit.

Impact of perinatal practices for early-onset group B Streptococcal disease prevention.

BACKGROUND: Prevention of residual cases of neonatal group B streptococcus (GBS) early-onset disease (EOGBS) has become a goal in the past decade. This study is aimed at evaluating changes in the incidence of EOGBS over a 9-year period after the implementation of a screening-based approach and comparing 2 different protocols for managing healthy-appearing at-risk newborns (ARNs). METHODS: A screening-based strategy was introduced in Emilia-Romagna (Italy) in 2003. A prospective, cohort study was conducted from 2003 to 2011; culture-proven EOGBS cases were analyzed in 2 periods: period 1 (2003 to 2008) and period 2 (2009 to 2011). ARNs (≥35 weeks' gestation) were managed according to 2 different protocols: laboratory testing plus observation (period 1) was replaced with expectant observation alone (period 2). RESULTS: Ninety-one EOGBS cases were observed (incidence rate: 0.26/1000 live births). The incidence in full-term babies declined from 0.30 (period 1) to 0.14/1000 live births (period 2, P = 0.04). Recto-vaginal screening cultures in full-term mothers increased significantly from 10/45 (period 1) to 10/14 (period 2, P = 0.002). EOGBS was diagnosed earlier in ARNs than in not-at-risk newborns (mean age 5.5 versus 14.5 hours, P = 0.007). There were no differences in age at diagnosis irrespective of whether ARNs were managed with laboratory testing plus observation (mean 3.5 hours, period 1) or with expectant observation alone (mean 2.4 hours, period 2). CONCLUSIONS: When screening cultures were handled according to standard protocols, cases of EOGBS in full-term newborns simultaneously decreased. ARNs were diagnosed in a timely manner through both strategies. The clinical yield of laboratory testing was negligible.

Group B streptococcus late-onset disease: 2003-2010.

BACKGROUND: There is insufficient population-based data on group B streptococcus (GBS) late-onset disease (LOD). Risk factors and routes of GBS transmission are poorly understood. METHODS: A prospective, cohort study was conducted to collect incidence data on LOD and evaluate GBS infections over an 8-year period (2003-2010). Starting from January 2007, maternal rectovaginal and breast milk cultures were routinely collected on confirmation of the LOD diagnosis to assess maternal GBS culture status. RESULTS: The incidence rate of LOD was 0.32 per 1000 live births (1.4 and 0.24 per 1000 live births for preterm and term newborns, respectively). The registered cases of LOD (n = 100) were classified as sepsis (n = 57), meningitis (n = 36), or focal infection (n = 7). Thirty neonates were preterm (2 had recurrent infection); 68 were term. Four infants died (3 early preterm, 1 term). At the time the LOD diagnosis was confirmed, 3 (6%) of 53 mothers had GBS mastitis, and 30 (64%) of 47 carried GBS at the rectovaginal site. Early (7-30 days) LOD presentation was associated with neonatal brain lesions or death (odds ratio: 0.96 [95% confidence interval: 0.93-0.99]). Intrapartum antibiotic exposure was significantly associated with mild (12 of 22) rather than severe (11 of 45; P = .03) LOD. CONCLUSIONS: Preterm neonates had the highest rates of LOD and mortality. Most mothers carried GBS at the time of the LOD diagnosis, whereas 6% had mastitis. Intrapartum antibiotics were associated both with delayed presentation of symptoms and milder LOD.