Le morti in utero: risultati di un progetto pilota di sorveglianza della mortalità perinatale in Italia (SPItOSS).

OBJECTIVES: to describe the results of a pilot population-based perinatal mortality surveillance system, with regards to stillbirths; to study maternal, obstetric, and foetal characteristics, evaluating risk factors and understanding causes. DESIGN: a cross-sectional study was conducted on incident cases of stillbirths collected by the surveillance system from July 2017 to June 2019 in three Italian Regions (Lombardy, Tuscany, and Sicily). SETTING AND PARTICIPANTS: data on stillbirths, resulting from the in-hospital multidisciplinary audits, organised using the Significant Event Audit methodology, were analysed. According to the World Health Organization (WHO) definitions, the project identified stillbirths as foetuses born dead >=28 weeks of gestation. The WHO International Classification of Diseases-Perinatal Mortality was used to categorise the causes of foetal death. MAIN OUTCOMES MEASURES: maternal characteristics, obstetric and foetal findings were investigated. Unadjusted relative risks and 95% confidence intervals were computed with respect to the background population. Finally, causes of death and contributing maternal conditions have been considered. RESULTS: the maternity and neonatal units of the three participating Regions notified 520 stillbirths, of which 435 cases underwent to the multidisciplinary audit (83.7%); 40.0% of cases occurred in the gestational age range between 36 and 39 weeks. The risk of stillbirth was significantly increased in mothers with foreign citizenship (RR: 1.39; 95%CI: 1.13-1.71), multiple pregnancies (RR: 1.59; 95%CI 1.05-2.42), and pregnancies conceived with assisted reproductive technologies (RR: 2.15; 95%CI 1.45-3.19). The rate of congenital malformations was 6.0%. A diagnosis of foetal growth restriction was reported in 10.3% of cases, although the percentage of dead foetuses weighting <10° centile was at least twice in almost all gestational age periods. Post-mortem and placental histological examinations were carried out in more than 70% and more than 90% of cases, respectively. CONCLUSIONS: the implementation of a population-based surveillance system with high participation rate of maternity units and the use of universally accepted definitions could improve the identification of stillbirth avoidable risk factors and potentially modifiable predisposing maternal conditions, highlighting issues of perinatal assistance in need of improvement.

Perinatal care in SARS-CoV-2 infected women: the lesson learnt from a national prospective cohort study during the pandemic in Italy.

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.

Monitoring medicine prescriptions before, during and after pregnancy in Italy.

BACKGROUND: The use of medications during pregnancy is a common event worldwide. Monitoring medicine prescriptions in clinical practice is a necessary step in assessing the impact of therapeutic choices in pregnant women as well as the adherence to clinical guidelines. The aim of this study was to provide prevalence data on medication use before, during and after pregnancy in the Italian population. METHODS: A retrospective prevalence study using administrative healthcare databases was conducted. A cohort of 449,012 pregnant women (15-49 years) residing in eight Italian regions (59% of national population), who delivered in 2016-2018, were enrolled. The prevalence of medication use was estimated as the proportion (%) of pregnant women with any prescription. RESULTS: About 73.1% of enrolled women received at least one drug prescription during pregnancy, 57.1% in pre-pregnancy and 59.3% in postpartum period. The prevalence of drug prescriptions increased with maternal age, especially during the 1st trimester of pregnancy. The most prescribed medicine was folic acid (34.6%), followed by progesterone (19%), both concentrated in 1st trimester of pregnancy (29.2% and 14.8%, respectively). Eight of the top 30 most prescribed medications were antibiotics, whose prevalence was higher during 2nd trimester of pregnancy in women ≥ 40 years (21.6%). An increase in prescriptions of anti-hypertensives, antidiabetics, thyroid hormone and heparin preparations was observed during pregnancy; on the contrary, a decrease was found for chronic therapies, such as anti-epileptics or lipid-modifying agents. CONCLUSIONS: This study represents the largest and most representative population-based study illustrating the medication prescription patterns before, during and after pregnancy in Italy. The observed prescriptive trends were comparable to those reported in other European countries. Given the limited information on medication use in Italian pregnant women, the performed analyses provide an updated overview of drug prescribing in this population, which can help to identify critical aspects in clinical practice and to improve the medical care of pregnant and childbearing women in Italy.

Uptake and Adherence to National Guidelines on Postpartum Haemorrhage in Italy: The MOVIE before-after Observational Study.

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.

Drug Prescriptions among Italian and Immigrant Pregnant Women Resident in Italy: A Cross-Sectional Population-Based Study.

Ensuring drug safety for pregnant women through prescription drug monitoring is essential. The aim of this study was to describe the prescription pattern of medicines among pregnant immigrant women from countries with high migratory pressure (HMPCs) compared to pregnant Italian women. The prevalence of drug prescriptions among the two study populations was analysed through record linkage procedures applied to the administrative databases of eight Italian regions, from 2016 to 2018. The overall prevalence of drug prescription was calculated considering all women who received at least one prescription during the study period. Immigrants had a lower prevalence of drug prescriptions before (51.0% vs. 58.6%) and after pregnancy (55.1% vs. 60. 3%). Conversely, during pregnancy, they obtained a slightly higher number of prescriptions (74.9% vs. 72.8%). The most prescribed class of drugs was the blood and haematopoietic organs category (category ATC B) (56.4% vs. 45.9%, immigrants compared to Italians), followed by antimicrobials (31.3% vs. 33.7%). Most prescriptions were appropriate, while folic acid administration 3 months before conception was low for both study groups (3.9% immigrants and 6.2% Italians). Progesterone seemingly was prescribed against early pregnancy loss, more frequently among Italians (16.5% vs. 8.1% immigrants). Few inappropriate medications were prescribed among antihypertensives, statins and anti-inflammatory drugs in both study groups.

A nationwide surveillance system to reduce perinatal death cases in Italy: implementing a population-based pilot project.

OBJECTIVES: to describe the methodology of a pilot perinatal mortality surveillance system (SPItOSS) aimed to improve quality of care and prevent avoidable perinatal severe morbidity and mortality in three Italian regions. DESIGN: population-based surveillance project monitoring incident cases of stillbirths, born dead ≥ 28 weeks of gestation and live births dying within 7 days. Local multidisciplinary audits in obstetric and neonatal units were conducted to assess causes of each death. A selection of deaths was also discussed by experts in regional and national Confidential Enquiries to assess causes and avoidability. The WHO perinatal mortality definition and the ICD-PM classification were adopted to codify perinatal deaths. SETTING AND PARTICIPANTS: health professionals working in any obstetric and neonatal unit in Lombardy (Northern Italy), Tuscany (Central Italy), and Sicily (Southern Italy), accounting for 32.3% of births in Italy. Data collection started on 01.07.2017 and ended on 30.06.2019. MAIN OUTCOME MEASURES: obstetric and neonatal units' participation rate in the participating regions, facility structural organisation description, health professionals' training course participation, estimate of perinatal death rates, clinical audits and Confidential Enquiries rates. RESULTS: health professionals from all obstetric and/or neonatal units (N. 138) joined the pilot project. Overall, 830 incident perinatal deaths were reported; 699 underwent a facility-based clinical audit, and 94 selected cases were analysed in detail through regional and national Confidential Enquiries. Among the latter, 16.0% were assessed as avoidable deaths. Interregional differences related to the facility structural organisation were identified. CONCLUSIONS: SPItOSS was efficient in identifying and analysing incident cases of perinatal deaths and detecting improvable aspects of care and avoidable perinatal deaths. The next objective is to extend the surveillance at the national level, considering that stable funding and a higher number of participating healthcare professionals and experts will be needed.

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.

The Italian Obstetric Surveillance System: Implementation of a bundle of population-based initiatives to reduce haemorrhagic maternal deaths.

In this before and after cross-sectional analysis, the authors aim to assess the impact of the bundle of research and training initiatives implemented between 2013 and 2018, and coordinated by the Italian Obstetric Surveillance System (ItOSS) to reduce obstetric haemorrhagic emergencies in five selected Italian Regions. To this purpose, the haemorrhagic Maternal Mortality Ratios (MMR) per 100,000 live births were estimated before and after implementing the bundle, through the ItOSS's vital statistic linkage procedures and incident reporting and Confidential Enquiries. The research and training bundle was offered to all health professionals involved in pregnancy and birth care in the selected regions, representing 40% of national live births, and participating in the ItOSS audit cycle since its institution. The haemorrhagic MMR significantly decreased from 2.49/100,000 live births [95% CI 1.75 to 3.43] in the years 2007-2013 prior to the bundle implementation, to 0.77/100,000 live births [95% CI 0.31 to 1.58] in the years 2014-2018 after its implementation. According to the study results, the bundle of population-based initiatives might have contributed to reducing the haemorrhagic MMR in the participating regions, thus improving the quality of care of the major obstetric haemorrhage.

Acceptance of e-Learning Programs for Maternity Health Care Professionals Implemented by the Italian Obstetric Surveillance System.

INTRODUCTION: Distance learning efficacy on physician performances and patient health outcomes has been demonstrated. This study explored the participation and evaluation of CME e-learning courses for Italian health care professionals addressing leading causes of maternal mortality identified by the Italian Obstetric Surveillance System (ItOSS) at the Italian National Health Institute, namely postpartum hemorrhage and pregnancy hypertensive disorders. METHODS: A model for two online free 12-hour case-based training courses was used. Data on participants were collected, anonymized, and transferred to the Italian National Health Institute for later analysis. Participants were requested to sign an online informed consent form. RESULTS: Twenty-one thousand five hundred thirty-two health care professionals enrolled to the courses from 2014 to 2017 as follows: midwives (14,187, 65.9%); obstetricians (3,716, 17.2%); anesthesiologists (1,896, 8.8%); and other medical specialists (1,733, 8.0%). Overall, 85% of participants acquired CME credits. Participants' satisfaction on quality, efficacy, and relevance was very high. DISCUSSION: ItOSS courses were able to reach a substantial number of different professional profiles involved in perinatal care all over the country; ItOSS courses can be considered an effective way to spread evidence-based good clinical practices. Nevertheless, further studies are needed to verify the improvement in professional health care skills and patient outcomes.

Women undergoing peripartum hysterectomy due to obstetric hemorrhage: A prospective population-based study.

INTRODUCTION: Peripartum hysterectomy is usually undertaken in cases of life-threatening obstetric hemorrhage to prevent the death of the mother. Near-miss events are still under-researched and inappropriate care continues to be a critical issue, even in countries with advanced obstetric surveillance systems. The aim of the present study was to estimate the prevalence, associated factors, management and intraoperative and postoperative complications of peripartum hysterectomy due to obstetric hemorrhage. MATERIAL AND METHODS: A prospective population-based study has been conducted in six Italian regions covering 49% of births in Italy. The study population comprised all women aged 11-59 years undergoing peripartum hysterectomy, from September 2014 to August 2016, due to obstetric hemorrhage within 7 days of delivery. In each maternity unit a trained reference person reported incident cases using electronic data collection forms. The background population comprised all women who delivered in the participating regions during the study period. RESULTS: The overall peripartum hysterectomy prevalence was 1.09 per 1000 maternities, with a large variability among regions, ranging from 0.52 to 1.60. Previous cesarean section (relative risk [RR] 4.97, 95% CI 4.13-5.96), assisted reproductive technology (RR 5.99, 95% CI 4.42-8.11) multiple pregnancy (RR 5.03, 95% CI 3.57-7.09) and maternal age ≥35 years (RR 2.69, 95% CI 2.25-3.21) were the main associated factors for hysterectomy. The most common causes of peripartum hysterectomy were uterine atony (45.1%) and abnormally invasive placentation (40.2%). Intensive care unit admission was reported in 49.9% of cases, 16.8% of women suffered severe morbidity and 5 women died. CONCLUSIONS: The rate of peripartum hysterectomy in Italy was three times higher compared with the UK, the Netherlands and the Nordic countries. The wide difference may be associated with women's characteristics, such as age at delivery and previous cesarean section, and with different management options leading to peripartum hysterectomy.

Maternal suicide in Italy.

Suicide has been identified as one of the most common causes of death among women within 1 year after the end of pregnancy in several high-income countries. The aim of this study was to provide the first estimate of the maternal suicide ratio and a description of the characteristics of women who died by suicide during pregnancy or within 1 year after giving birth, induced abortion or miscarriage (i.e., maternal suicide) in 10 Italian regions, covering 77% of total national births. Maternal suicides were identified through the linkage between regional death registries and hospital discharge databases. Background population data was collected from the national hospital discharge, abortion and mortality databases. The previous psychiatric history of the women who died by maternal suicide was retrieved from the regionally available data sources. A total of 67 cases of maternal suicide were identified, corresponding to a maternal suicide ratio of 2.30 per 100,000 live births in 2006-2012. The suicide rate was 1.18 per 100,000 after giving birth (n = 2,876,193), 2.77 after an induced abortion (n = 650,549) and 2.90 after a miscarriage (n = 379,583). The majority of the women who died by maternal suicide (34/57) had a previous psychiatric history; 15/18 previously diagnosed mental disorders were not registered along with the index pregnancy obstetric records. Suicide is a relevant cause of maternal death in Italy. The continuity of care between primary, mental health and maternity care were found to be critical. Clinicians should be aware of the issue, as they may play an important role in preventing suicide in their patients.

The way to move beyond the numbers: the lesson learnt from the Italian Obstetric Surveillance System.

OBJECTIVE: To describe the Italian Obstetric Surveillance System (ItOSS) investigating maternal death through incident case reporting and confidential enquiries. METHODS: All maternal deaths occurred in any public and private health facility in 8 Italian regions covering 73% of national births have been notified to the ItOSS. Every incident case is confidentially reviewed to assess quality of care and establish the cause and avoidability of the death. FINDINGS: A total of 106 maternal deaths among 1 455 545 live births have been notified to the surveillance system in 2013-17. Haemorrhage, sepsis and hypertensive disorders of pregnancy are the leading causes of direct maternal deaths due to obstetric causes. CONCLUSIONS: A maternal mortality surveillance system, including incidence reporting and confidential enquiries along with a retrospective analysis of administrative data sources, emerged as the best option for case ascertainment and for preventing avoidable maternal deaths.

Maternal mortality in Italy: Results and perspectives of record-linkage analysis.

INTRODUCTION: Accurate estimates and reliable classification of maternal deaths are imperative steps in the chain of actions targeted at reducing avoidable maternal mortality. The aims of this study were to estimate the maternal mortality ratio (MMR) in 10 Italian regions covering 77% of total national births and to identify the most suitable approach to classify the causes of death. MATERIAL AND METHODS: Deaths during and within 1 year after pregnancy have been identified through linkage between death registry and hospital discharge database. Regional and national data sources from 2006 to 2012 were used. The MMR has been estimated and deaths were classified as direct or indirect and according to their primary causes. RESULTS: A total of 277 maternal deaths within 42 days after pregnancy were identified: 149 direct, 102 indirect causes and 26 unclassified-resulting in a MMR of 9.18 per 100 000 live births. The under-reporting rate of official MMR figures in the participating regions is 60.3%. Hemorrhage (MMR 1.92), hypertensive disorders of pregnancy and cardiac diseases (MMR 1.06) were the leading causes of deaths occurring within 42 days after pregnancy, whereas malignancy (39%) and violent deaths (17%) were the most frequent of the 543 late maternal deaths. CONCLUSIONS: Record-linkage is an efficient and reliable method to estimate maternal mortality and to identify causes of maternal deaths. Both the indirect/direct and the classification by primary cause have a role in countries where direct deaths exceed indirect maternal mortality. Building upon linkage data, confidential enquiries further increase the likelihood of reducing maternal mortality.

Drug prescribing during pregnancy in a central region of Italy, 2008-2012.

BACKGROUND: Drug consumption during pregnancy is a matter of concern, especially regarding drugs known or suspected to be teratogens. Little is known about drug use in pregnant women in Italy. The present study is aimed at examining the prevalence, and to detect potential inappropriateness of drug prescribing among pregnant women in Latium, a region of central Italy. METHODS: This retrospective study was conducted on a cohort of women aged 18-45 years who delivered between 2008 and 2012 in public hospitals. Women were enrolled through the Regional Birth Register. After linking the regional Health Information Systems and the Regional Drug Claims Register, women's clinical data and prescribed medications were analyzed. Italian Medicine Agency (AIFA) and US Food and Drug Administration (FDA) evidence were used to investigate inappropriate prescribing and teratogenic risk. RESULTS: Excluding vitamins and minerals, 80.6% (n = 153,079) of the women were prescribed at least one drug during pregnancy, with an average of 4.6 medications per pregnancy. Drugs for blood and hematopoietic organs were the most commonly prescribed (53.0%,), followed by anti-infectives for systemic use (50.7%). Among the inappropriate prescriptions, progestogen supplementation was given in 20.1% of pregnancies; teratogen drugs were prescribed in 0.8%, mostly angiotensin co-enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) (0.3%). CONCLUSIONS: In Latium, drugs are widely used in pregnancy. Prescriptions of inappropriate drugs are observed in more than a fifth of pregnancies, and teratogens are still used, despite their known risk. Continuous updates of information provided to practitioners and an increased availability of information to women might reduce inappropriate prescribing.

[WHO GLOSS: a global study to promote the reduction of preventable maternal and neonatal deaths related to sepsis.] / WHO GLOSS: uno studio globale per ridurre le morti materne e neonatali da sepsi.

The study aims to promote the reduction of preventable maternal and neonatal deaths related to sepsis worldwide. To achieve this goal, the study will test new WHO criteria for early identification of maternal sepsis across both low and high resource settings, describe and analyze the frequency and outcomes of suspected or confirmed maternal sepsis for mothers and infants. Additionally, in the European participating countries, the study will describe the patterns of anti-microbial usage amongst women with suspected maternal sepsis, explore migration status amongst women with possible severe maternal infection and describe any variations in their management.

Do Italian pregnant women use periconceptional folate supplementation?

INTRODUCTION: Deficiency of folic acid (FA) has been identified as a risk factor for neural tube defects (NTDs) as well as other congenital anomalies. Thus, periconceptional folate supplementation is recommended for all women planning to get pregnant. METHODS: We conducted a KAP (knowledge, attitude, practice) survey to investigate the use of FA and its appropriateness. The survey included a sample of 562 women who delivered in the Lazio region between 2013 and 2014. Two logistic regression analyses were performed to evaluate the association between the characteristics of participating women and both the information received on FA intake and its use. RESULTS: The prevalence of periconceptional FA assumption was 19.4% although 82.2% of the interviewed women had planned their pregnancies. CONCLUSIONS: It shows that more periconceptional counseling is needed to increase women's awareness on the opportunity of FA supplementation.

Human oocyte cryopreservation with slow freezing versus vitrification. Results from the National Italian Registry data, 2007-2011.

OBJECTIVE: To compare mature human oocytes cryopreservation with slow freezing (SF) and vitrification (VT) in infertile couples. DESIGN: Retrospective study of national Italian data submitted during the period 2007-2011. SETTING: National ART registry. PATIENT(S): Infertile patients with supernumerary oocytes. INTERVENTION(S): Thawing or warming of cryopreserved oocytes and ICSI. MAIN OUTCOME MEASURE(S): oocyte survival, fertilization, implantation and clinical pregnancy rate between SF and VT. RESULT(S): A total of 14,328 cycles with 11,599 transfers, 1,850 pregnancies, 1,168 deliveries and 1,342 babies born were analyzed from 146 reporting centers (range of cycles 1-1,255 per center). The SF oocytes' survival rate was lower than in VT (51.1% vs. 63.1%). Fertilization rate was significantly higher in SF than in VT (SF 71.6% vs. VT 70.1%). VT showed a significantly higher pregnancy rate, both per started cycle (14.4% vs. 12.0%) and per transfer (18.0% vs. 14.8%), and implantation rate (9.5% vs. 8.1%) than SF. However, the range and median pregnancy rate per started cycle were, respectively, 0%-50% and 7.7% in SF and 0%-100% and 6.7% in VT. CONCLUSION(S): VT showed a statistically significant higher performance than SF. As with other ART procedures, the results are not homogeneous among clinics and protocols, but the confirm the clinical value of oocyte cryopreservation in infertile patients.

Hair and urine testing to assess drugs of abuse consumption in couples undergoing assisted reproductive technology (ART).

For the first time in Europe hair and urine testing have been applied to assess drugs of abuse consumption in couples undergoing assisted reproductive technology and the eventual association of toxic habits with other lifestyle, health status and sociodemographic factors was also investigated. Couples attending five assisted reproduction centers in Rome were invited to join the study. When they presented at the Centre for the visit, they were asked to answer a structured questionnaire concerning sociodemographic characteristics and lifestyle habits, and at the same time to provide hair and urine samples. Hair and urine testing for drugs of abuse, urinary profile of principal endogenous steroids involved in fertility process (testosterone, epitestosterone, androsterone, etiocholanolone and dehydroepiandrosterone) and of alcohol and tobacco smoke biomarkers were performed with validated methodologies. Of the 594 enrolled individuals (297 couples), 352 (164 couples and 24 single individuals from the couple) completed the questionnaire and gave both hair and urine samples, apart from 3 bald men, who only gave urine samples. Urine testing showed an overall 4.8% (17 individuals) positivity to drugs of abuse: 4.2% to cannabinoids, 1.4% to cocaine and 0.85% to both drugs. Results of 4cm segment hair samples testing matched those from urine samples. Thus, taking together, results of urine and hair testing confirmed repeated use of cannabis, cocaine and both drugs in 3.7, 0.85 and 0.57% examined individuals, respectively. Drug consumers were in a statistically higher percentage active smokers and alcohol drinkers, less prone to physical activity and with a trend towards higher weight than non consumers. Finally, repeated drug consumption was associated with significant lower concentration of urinary testosterone in males and of urinary dehydroepiandrosterone in females. The findings of the present study confirm the suitability of urine testing to disclose recent drugs of abuse consumption and of hair analysis to verify repeated consumption. Association between different toxic habits and sedentary lifestyle is also substantiated by the obtained results in our cohort of couples attending assisted reproduction centers.