OBJECTIVES:Concurrence of pregnancy and cancer diagnosis is increasingly frequent in Italy. The study aimed to compare women with pregnancy-associated cancers (PACs) to those of childbearing age, focusing on fertility, induced abortion, and miscarriage. METHODS:The population-based study included women aged 15-49 years, both with and without PAC, who were residents in the area covered by the 19 participating Cancer Registries between 2003 and 2015 and identified by individual deterministic linkage with the Hospital Discharge Database. RESULTS:Overall, 2,218,139 obstetrics hospitalizations occurred, covering delivery (75%), induced abortion (14%), and miscarriage (11%). Among 2409 women with PAC, 69% gave birth, 16% had an induced abortion and 15% a miscarriage. Compared with the reference population, the fertility rate in women with PACs was steadily lower (mean values 25.7/1000 vs 37.7/1000), while induced abortion (from 359/1000 - SRR 1.99, 95%CI 1.32-3.00 - in 2003 to 147/1000 - SRR 1.11, 95%CI 0.59-2.09 - in 2015) and miscarriage ratios exhibited a decreasing trend. CONCLUSION:These results are consistent with international literature and are probably due to advancements in diagnostic and therapeutic opportunities. This is the first Italian population-based study analysing fertility and pregnancy outcomes among women with PAC based on a reliable information on cancer diagnosis.

This study aimed to calculate Italy's first national maternal mortality ratio (MMR) through an innovative record-linkage approach within the enhanced Italian Obstetric Surveillance System (ItOSS). A record-linkage retrospective cohort study was conducted nationwide, encompassing all women aged 11-59 years with one or more hospitalizations related to pregnancy or pregnancy outcomes from 2011 to 2019. Maternal deaths were identified by integrating data from the Death Registry and national and regional Hospital Discharge Databases supported by the integration of findings from confidential enquiries conducted through active surveillance. Maternal Mortality Ratio (MMR), direct MMR (DMMR), and causes of maternal death are the study main outcomes. The MMR was found to be 8.4 per 100,000 live births (95% CI 7.5-9.3), significantly higher than the 3.9 per 100,000 (95% CI 3.3-4.5) calculated solely from the Death Registry, with a notable declining trend over the study period. Causes of death have been classified according to the 10th International Classification of Diseases. Within 42 days from pregnancy outcome, leading causes were obstetric haemorrhage, sepsis, and cardiovascular diseases. Late maternal deaths were primarily attributed to suicide, malignancies, and cardiovascular diseases. This integrated methodology provides a comprehensive understanding of maternal mortality trends and causes in Italy, offering valuable insights for countries utilizing or planning enhanced surveillance systems.

Synopsis All pregnant women at risk should be screened for Chagas disease, as recommended by the Italian National Institute of Health.

OBJECTIVES:Evidence on the effects of the SARS-CoV-2 Omicron variant on vaccinated and unvaccinated pregnant women is sparse. This study aimed to compare maternal and perinatal outcomes of women infected with SARS-CoV-2 during the Omicron wave in Italy, according to their vaccine protection. METHODS:This national prospective cohort study enrolled pregnant women with a positive SARS-CoV-2 nasopharyngeal swab within 7 days of hospital admission between 1 January and 31 May, 2022. Women who received at least one dose of vaccine during pregnancy and those who completed the vaccine cycle with the first booster were considered protected against moderate or severe COVID-19 (MSCD). A multivariable logistic regression model evaluated the association between vaccine protection and disease severity. Maternal age, educational level, citizenship, area of birth, previous comorbidities, and obesity were analysed as potential risk factors. RESULTS:MSCD was rare (41/2147, 1.9%; 95% CI, 1.4-2.6), and the odds of developing it were significantly higher among unprotected women (OR, 2.78; 95% CI, 1.39-5.57). Compared with protected women (n = 1069), the unprotected (n = 1078) were more often younger, with lower educational degrees, and foreigners. A higher probability of MSCD was found among women with previous comorbidities (OR, 2.86; 95% CI, 1.34-6.12) and those born in Asian countries (OR, 3.05; 95% CI, 1.23-7.56). The percentage of preterm birth was higher among women with MSCD compared with milder cases (32.0% [8/25] versus 8.4% [161/1917], p < 0.001) as well as the percentage of caesarean section (52.0% [13/25] versus 31.6% [606/1919], p 0.029). DISCUSSION:Although severe maternal and perinatal outcomes were rare, their prevalence was significantly higher among women without vaccine protection. Vaccination during pregnancy has the potential to protect both the mother and the baby, and it is therefore strongly recommended.

Translating evidence-based guidelines into clinical practice is a complex challenge. This observational study aimed to assess the adherence to the Italian national guidelines on postpartum haemorrhage (PPH) and describe the clinical management of haemorrhagic events in a selection of maternity units (MUs) in six Italian regions, between January 2019 and October 2020. A twofold study design was adopted: (i) a before–after observational study was used to assess the adherence to national clinical and organisational key recommendations on PPH management, and (ii) a cross-sectional study enrolling prospectively 1100 women with PPH ≥ 1000 mL was used to verify the results of the before–after study. The post-test detected an improved adherence to 16/17 key recommendations of the guidelines, with clinical governance and communication with family members emerging as critical areas. Overall, PPH management emerged as appropriate except for three recommended procedures that emphasise different results between the practices adopted and the difference between what is considered acquired and what is actually practised in daily care. The methodology adopted by the MOVIE project and the adopted training materials and tools have proved effective in improving adherence to the recommended procedures for appropriate PPH management and could be adopted in similar care settings in order to move evidence into practice.

Maternal sepsis represents a leading cause of mortality and severe morbidity worldwide. In Italy, it is the second cause of direct maternal mortality. Delay in recognition and treatment initiation are the drivers of sepsis-associated adverse outcomes. Between November 2017 and October 2019, the Italian Obstetric Surveillance System coordinated a prospective population-based study on maternal sepsis occurring before or after childbirth from 22 weeks’ gestation onward and up to 42 days following the end of pregnancy. A nested 1:2 matched case-control study on postpartum sepsis was also performed. Maternal sepsis was diagnosed for the presence of suspected or confirmed infection alongside signs or symptoms of organ failure. The aim of this study was to assess maternal sepsis incidence and its associated risk factors, management, and perinatal outcomes. Six Italian regions, covering 48.2% of the national births, participated in the project. We identified an incidence rate of 5.5 per 10,000 maternities (95% CI 4.80–6.28). Seventy percent of patients had a low education level and one third were foreigners with a language barrier. Genital, respiratory, and urinary tract infections were the predominant sources of infection; the majority of cases was caused by E. coli and polymicrobial infections. The presence of vascular and indwelling bladder catheters was associated with a nine-fold increased risk of postpartum sepsis. There were no maternal deaths, but one fourth of women experienced a serious adverse event and 28.3% required intensive care; 1.8% of newborns died. Targeted interventions to increase awareness of maternal sepsis and its risk factors and management should be promoted.

Objectives: to describe the monthly trend of breastfeeding during hospitalization and the presence of companion of woman's choice during labour and birth, and the key regional responders' perspective of homogeneity/heterogeneity of the presence of the support person, before, during (February-May 2020), and after the first COVID-19 pandemic wave in a few Italian Regions.Design: two-phase study.Setting and participants: data from the italian birth certificate of six Italian Regions between 01.01.2019 and 31.03.2021 were analysed. Semi-structured interviews were conducted with the key regional respondents.Main outcome measures: the frequency distributions of breastfeeding and the presence of companion of woman's choice were calculated as a whole and for each Region.Results: the infant feeding practices experienced smaller changes during COVID-19 pandemic than the presence of the companion of woman's choice during labour and birth, from January 2019 to March 2021. The highest value of exclusive breastfeeding was recorded in September 2020 (72.1%; 95%CI 71.3-72.8) in all Regions, while the lowest was recorded in March 2021 (62.5%; 95%CI 61.5-63.4). The presence of companion of woman's choice during labour and birth decreased during the pandemic and did not re-turn to pre-pandemic levels. The highest value of presence of father during birth was recorded in March 2019 (59.0%; 95%CI 58.2-59.8), while the lowest in April 2020 (50.0%; 95%CI 49.1-50.8). The main emerging themes were: the existence of national, regional and local indications; the facilitators (e.g., Baby-Friendly Hospital Initiative implementation, strong motivation of the staff) and the critical points (e.g., inadequate analysis of the clinicalepidemiological context, inhomogeneous indications) of management of the support person presence.Conclusions: the emergency has changed the provision of health services that not always guaranteed the applicationof best practices. It would be desirable to work for assessing the appropriateness of the birth certificate data to collect more accurate information and to provide clinical recommendations.

Italy is one of the European Countries with the highest caesarean section (CS) rate and large regional and local variability. In 2021, Calabria Region ranked as the third Italian region for the highest CS rate (38.5%). Calabria Region has joined the "Easy-Net" network program of Ministry of Health (NET-2016-02364191) on the evaluation of audit & feedback (A&F) interventions (Easy-Net https://easy-net.info/). The Easy-Net project is coordinated by The Department of Epidemiology of the Lazio Regional Health Service, and led for the Calabria Region by the Pugliese-Ciaccio Hospital of Catanzaro, with the Italian Ministry of Health and the Italian National Institute of Health. This project aims to reduce CS rate in Calabria Region, through A&F strategy interventions to improve perinatal care quality and maternal and neonatal outcomes. The adopted multi-strategic approach involves the use of Robson's classification to improve the appropriateness of the CS indications, and the A&F activities to identify health professionals' training needs and offer training update. This article describes the protocol of the Easy-Net WP6 study, "Prospective audit and feedback approach: efficacy in improving healthcare practice and reducing the caesarean section rate" (NET-2016-02364191-6). The project is organized in five phases which envisage the pre-intervention data collection relating to indicators of interest and staff attitudes on CS indication and A&F strategy. The 12 months of A&F interventions will be followed by the post-intervention data collection and the evaluation of appropriateness indicators and determinants. A study aimed at women is also planned to detect opinions regarding the use of CS. The study protocol was approved by the Ethics Committee of the Pugliese Ciaccio Hospital.

Background Despite the growing importance given to ensuring high-quality childbirth, perinatal good practices have been rapidly disrupted by SARS-CoV-2 pandemic. This study aimed at describing the childbirth care provided to infected women during two years of COVID-19 emergency in Italy. Methods A prospective cohort study enrolling all women who gave birth with a confirmed SARS-CoV-2 infection within 7 days from hospital admission in the 218 maternity units active in Italy during the periods February 25, 2020-June 30, 2021, and January 1-May 31, 2022. Perinatal care was assessed by evaluating the prevalence of the following indicators during the pandemic: presence of a labour companion; skin-to-skin; no mother–child separation at birth; rooming-in; breastfeeding. Logistic regression models including women’ socio-demographic, obstetric and medical characteristics, were used to assess the association between the adherence to perinatal practices and different pandemic phases. Results During the study period, 5,360 SARS-CoV-2 positive women were enrolled. Overall, among those who had a vaginal delivery ( n = 3,574; 66.8%), 37.5% had a labour companion, 70.5% of newborns were not separated from their mothers at birth, 88.1% were roomed-in, and 88.0% breastfed. These four indicators showed similar variations in the study period with a negative peak between September 2020 and January 2021 and a gradual increase during the Alpha and Omicron waves. Skin-to-skin (mean value 66.2%) had its lowest level at the beginning of the pandemic and gradually increased throughout the study period. Among women who had a caesarean section ( n = 1,777; 33.2%), all the indicators showed notably worse outcomes with similar variations in the study period. Multiple logistic regression analyses confirm the observed variations during the pandemic and show a lower adherence to good practices in southern regions and in maternity units with a higher annual number of births. Conclusions Despite the rising trend in the studied indicators, we observed concerning substandard childbirth care during the SARS-CoV-2 pandemic. Continued efforts are necessary to underscore the significance of the experience of care as a vital component in enhancing the quality of family-centred care policies.

Objective: To estimate the incidence, and to investigate risk factors, management, and perinatal outcomes of eclampsia in Italy.Study design: This is a prospective population-based cohort study enrolling all women admitted for eclampsia between November 2017 and March 2020. Incident cases were reported using electronic and anonymous data collection forms.Main outcome measures: Incidence, risk factors, maternal and perinatal morbidity, and mortality.Results: 109 cases were included for an estimated incidence rate of 1.5 (95 % CI 1.2-1.8) per 10.000 births. Risk of developing eclampsia was associated with multiple pregnancies (RR = 4.51; p < 0.001) and with pregnancies achieved with assisted reproductive technologies (RR = 3.03; p < 0.001). Magnesium sulfate was used as prophylaxis in almost 30 % of women with preeclampsia, and to treat an eclamptic fit in 89 % of women. The time interval between the first fit and delivery was 62 min for antepartum and 10 min for intrapartum cases. Around one third of women developed at least one other major complication and one mother died. Severe morbidity affected 13.3 % of the newborns. Two fetal and one neonatal death were reported.Conclusions: Our data revealed low incidence of eclampsia in Italy and prompt administration of antihypertensive drugs and magnesium sulfate to prevent eclampsia and to treat the recurrence of seizures. However, the rate of severe maternal complications is still high: increasing the time interval between fit and delivery seems to be crucial to achieve an effective stabilization of maternal conditions and reduce maternal major complications.

The variety of placental morphological findings with SARS-CoV-2 maternal infections has raised the issue of poor agreement in histopathological evaluation. The aims of this study were: to describe the histopathological placental features of a large sample of SARS-CoV-2-positive women who gave birth in Italy during the COVID-19 pandemic, to analyse the factors underlying these lesions, and to analyse the impact of placental impairment on perinatal outcomes. From 25 February 2020 to 30 June 2021, experienced perinatal pathologists examined 975 placentas of SARS-CoV-2-positive mothers enrolled in a national prospective study, adopting the Amsterdam Consensus Statement protocol. The main results included the absence of specific pathological findings for SARS-CoV-2 infections, even though a high proportion of placentas showed signs of inflammation, possibly related to a cytokine storm induced by the virus, without significant perinatal consequences. Further research is needed to better define the clinical implications of placental morphology in SARS-CoV-2 infections, but the results of this large cohort suggest that placentas do not seem to be a preferential target for the new Coronavirus infection.

BACKGROUND:immigrant women diagnosed with gestational diabetes mellitus (GDM) have additional language and cultural obstacles in following lifestyle and dietary recommendations within a Western health care setting.OBJECTIVES:to describe: • sociodemographic characteristics and dietary and lifestyle behaviours in Italian and immigrant pregnant women who underwent a GDM screening; • any differences in these aspects among GDM Italian and immigrant women; • any differences in terms of primary maternal-neonatal outcomes among GDM and normal glucose tolerance (NGT) cohorts.DESIGN:survey.SETTING AND PARTICIPANTS:this survey was conducted in three hospitals located in Tuscany Region (Central Italy). According to a convenience sampling, an ad hoc questionnaire was administered both to Italian and immigrant women who underwent an oral glucose tolerance test.MAIN OUTCOME MEASURES:information about nutrition and lifestyle, medical and obstetric history, clinical and therapy data, maternal and neonatal primary outcomes was analysed. Eating habits have been investigated referring to the prudent diet, in order to also include those foods specifically consumed by the immigrant women, in addition to the Mediterranean Diet which is more widespread among Italians.RESULTS:a total of 117 Italian women (42 diagnosed with GDM) and 95 immigrant women (36 with GDM) were enrolled. Immigrant women showed lower adherence to the prudent diet compared to Italian women (p<0.05) and a broader use of unhealthy food preparation (e.g., frying; p<0.05). Primary maternal and neonatal outcomes (preterm birth, caesarean section, macrosomia) showed no statistical differences among GDM and NGT cohorts.CONCLUSIONS:even if immigrant and Italian women gained similar pregnancy outcomes, immigrant women showed lower adherence to the prudent diet at the time of GDM screening. An ethnic and tailored meal plan is needed to overcome cultural barriers in dietary recommendations during pregnancy in immigrant women.

The primary aim of this article was to describe SARS‐CoV‐2 infection among pregnant women during the wild‐type and Alpha‐variant periods in Italy. The secondary aim was to compare the impact of the virus variants on the severity of maternal and perinatal outcomes.

INTRODUCTIONThis study aimed to estimate the incidence of SARS-CoV-2 infection among pregnant women during the first pandemic wave in Italy, and to describe COVID-19 disease characteristics and maternal and perinatal outcomes.MATERIALS AND METHODSNational population-based prospective cohort study collecting information on women with SARS-CoV-2 diagnosis, confirmed within 7 days from hospital admission.RESULTSThe national SARS-CoV-2 rate was 6.04 per 1,000 births (95% CI 5.62-6.49) among pregnant women and 7.54 (95% CI 7.47-7.61) among women in reproductive age. 72.1% of the cohort developed mild COVID-19 disease without pneumonia nor need for ventilatory support. Severe disease was significantly associated with women's previous comorbidities (OR 2.55; 95% CI 0.98-6.90), obesity (OR 4.76; 95% CI 1.79-12.66) and citizenship from High Migration Pressure Countries (OR 3.43; 95% CI 1.27-9.25).CONCLUSIONSDuring the first pandemic wave in Italy, the SARS-CoV-2 rate among pregnant women was lower compared to that detected among women of reproductive age, and risks of severe COVID-19 disease and adverse maternal and perinatal outcomes were rare.

Objectives: To assay the presence of the SARS-CoV-2 genome in vaginal, rectal, and placental swabs among pregnant women and in newborn nasopharyngeal swabs and to investigate the immunological response and maternal antibody transfer through the umbilical cord blood and milk of unvaccinated mothers. Methods: Vaginal, rectal, and placental specimens, maternal and neonatal serum, and milk were collected from a wide cohort of pregnant Italian women with confirmed SARS-CoV-2 infection admitted to the hospital between February 25, 2020 and June 30, 2021. Samples were tested in selected reference laboratories according to a shared interlaboratory protocol. Results: Among 1086 enrolled women, the SARS-CoV-2 positive rate detected in all specimens ranged from 0.7% to 8.4%. Respectively, 45.2% of maternal sera collected during pregnancy and 39.7% of those collected at birth tested positive for immunoglobulin G, whereas 50.5% tested positive among neonates. Nasopharyngeal swabs were positive in 0.8% of the newborns, and immunoglobulin G was detected in 3.0% of the milk samples. The highest immunological response was recorded within 30 days during pregnancy and within 60 days of birth and in the neonatal population. Conclusion: Vertical transmission should be considered a rare event; although, a good maternal immunological response and antibodies transfer throughout the umbilical cord blood was detected.

Introduction Spontaneous hemoperitoneum in pregnancy is defined as a sudden non-traumatic intraperitoneal bleeding in pregnancy and up to 42 days postpartum. In the present study we aim to estimate the incidence and investigate the risk factors, the management and the outcomes of spontaneous hemoperitoneum in pregnancy in order to improve its clinical identification and reduce avoidable maternal deaths. Material and methods This is a prospective population-based cohort study, set in maternity units from nine Italian regions covering 75% of the national births. The study population comprises all women admitted for spontaneous intraperitoneal hemorrhage during pregnancy and up to 42 days postpartum between November 2017 and March 2020. Incident cases were reported by trained clinicians through electronic data collection forms. Descriptive statistics were performed. The main outcome measures included incidence rate of spontaneous hemoperitoneum in pregnancy, association with potential risk factors, clinical management and maternal and perinatal outcomes. Results Twenty-nine cases met the adopted definition of spontaneous hemoperitoneum in pregnancy with an estimated incidence rate of 0.04 per 1000 births. An increased risk ratio (RR) of this condition was observed in pregnancies conceived by assisted reproductive technology (RR = 6.60, 95% CI 2.52-17.29), in the case of multiple pregnancies (RR = 6.57, 95% CI 1.99-21.69) and maternal age >= 35 years (RR 2.10, 95% CI 1.01-4.35). In 17/29 cases the bleeding site was intra-pelvic (23.5% in the posterior uterine wall and 35.2% in the left hemipelvis). Laparotomy represented the surgical treatment in 27 cases (93%), and most women underwent a cesarean delivery (92.6%). Median blood loss was 1900 mL, one hysterectomy was necessary, and two women died. Twenty-two preterm births were recorded. Conclusions Spontaneous hemoperitoneum in pregnancy is a rare, life-threatening condition associated with high perinatal morbidity and mortality. Maternal age >= 35 years, multiple pregnancies and assisted reproductive technology were associated to a higher risk of the condition. Two women of 29 died and 70% of births occurred preterm.

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.

This summary is based on the 2nd edition of the "Interim guidance on pregnancy, childbirth, breastfeeding and care of infants (0-2 years) in response to the COVID-19 emergency. Update of the INIH COVID-19 Report n. 45/2020", published on 5 February 2021.1

Objectives To describe a cohort of Italian women with confirmed COVID-19 infection admitted during pregnancy for out or inpatient hospital care, in order to provide rapid feedback for clinicians and policymakers. Design National population-based cohort study. Setting 297 Italian public and private maternity units. Population Pregnant women with COVID-19 infection confirmed by RT-PCR testing through nasopharyngeal swab and/or chest RX or CT findings and/or antibody response from maternal blood. Exclusion criteria: age <18 years, refusal to participate and inability to give consent to participation. Methods A network of 351 trained reference clinicians enrols eligible women after acquiring an informed consent and completes a data entry form through a secure web-based system. Main outcome measures COVID-19 pneumonia, invasive respiratory support, ICU admission, women’s severe morbidity and mortality Results Over 80% of the 65 cases occurred in Northern Italy. Women’s mean age is 33.8 years. Gestational age at presentation is ≤14 weeks in 15.6% of the cases, 15-27 weeks in 51.6% and ≥28 weeks in 32.8% women. Pneumonia affects 41.5% of the cohort; three women have severe complications and are admitted to ICU. None has died. Conclusions The study describes the course of COVID-19 infection in a cohort of pregnant women, providing valuable information to improve clinical and logistical management of these cases. Questions arising from the study deserve further research.