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1. Improvement in Diagnostic-Therapeutic Care Pathways for Women with Migraine: An Italian Delphi Panel

Author

Cevoli, S, Barbanti, P, Finocchi, C, Benedan, L, Mariani, P, Orthmann, N, Bauleo, S, Brusa, P, Cianci, D, Marozio, L, Masseroni, S, Sangermani, R, Frediani, F, Allais, G, Barbanti,P, Finocchi,C, Benedan,L, Mariani,P, Frediani , F, Allais,G, Cevoli, S, Barbanti, P, Finocchi, C, Benedan, L, Mariani, P, Orthmann, N, Bauleo, S, Brusa, P, Cianci, D, Marozio, L, Masseroni, S, Sangermani, R, Frediani, F, Allais, G, Barbanti,P, Finocchi,C, Benedan,L, Mariani,P, Frediani , F, and Allais,G

Abstract

Background: Migraine is a highly underestimated and burdensome disease. Real-world studies evidence that migraine is more frequent and severe in women than men. However, to this day, no diagnostic-therapeutic pathways exist to satisfy the specific needs of female patients. Methods: In this study, migraine experts, specialists in women’s health, patient, and decision makers, analyzed the diagnostic and therapeutic options for women with migraine across various ages and health conditions within the Italian healthcare system. A Delphi approach was used to formulate statements and achieve a consensus. Results: Gaps in clinical practice were identified, and strategies to accommodate women’s needs were proposed. The experts agreed that a socio-behavioral intervention should be planned before any pharmacological treatment in pediatric/adolescent female patients and that the assessment of migraine with aura is considered crucial for adult women requiring contraceptive therapy. Acupuncture emerged as an effective treatment for pregnant and breastfeeding women, and hormone-replacement therapy selection in menopausal patients requires careful consideration to mitigate safety risks. The experts highlighted the absence of literature and guidelines for the management of migraine in women undergoing assisted reproductive procedures or oncological treatment. In light of these observations, the experts advocated the establishment of multidisciplinary collaborations between neurologists/headache specialists and other healthcare professionals, including general practitioners, pediatricians, gynecologists, and oncologists. Comprehensive migraine education for all healthcare professionals potentially involved in managing the disease, including pharmacists, was emphasized. Efforts to increase migraine awareness among women should be prioritized. Conclusion: The insights gained from this Italian consensus study should serve to develop an improved, female-specific pathway to diagnose and t

Published
2024

2. Reduced prevalence of fetal exposure to alcohol in Italy: a nationwide survey

Author

Camandona, F, Vaccari, L, Travan, L, Maso, G, Stampalija, T, Zanazzo, L, Pisana, P, Driul, L, Barbui, E, Caissutti, C, Valente, E, Ricchi, A, Bettiga, E, Piccolo, E, Pati, M, Pedori, S, Antonazzo, P, Sottile, G, Lo Faro, F, Tini, A, Massacesi, M, Rapisarda, C, Vivirito, G, Pinna, G, D'Anna, M, Klein, L, Bucolo, A, D'Anna, R, Monaco, C, La Ferrera, G, Capobianco, G, Olzai, M, Angioni, S, D'Alterio, M, Serravalle, P, Vicquery, C, Scalchi, S, Morando, C, Meneghin, M, Scapolan, C, Maggino, T, Guarinoni, B, Cristina Napolitano, G, De Vita, M, Di Carlo, C, Interlandi, F, Bisceglia, M, Michelangelo, B, Arnulfo, A, Finale, E, Marozio, L, Natali, I, Grazia, S, Staffler, A, Tarani, L, Coriale, G, Messina, M, D'Angelo, A, Bonito, M, Haass, C, Capasso, L, Raimondi, F, De Bernardo, G, Iacobelli, P, Spadarella, S, Enrica, M, Rabuano, R, Calzatini, F, Bossi, A, Aversa, S, Prefumo, F, Bellan, C, Leone, G, Ciammella, M, Von-Wunster, S, Liguori, A, Ornaghi, S, Fumagalli, S, Sanguineti, F, Gianola, G, Cagnacci, A, Amidani, A, Sisto, A, Di Marcello, F, Santillo, V, Di Bartolomeo, C, Gerli, S, Cagnoli, G, Petrisano, M, Pesce, S, Di Lascio, N, Falvino, S, Appio, P, Targiani, V, Cavaliere, A, Turrini, I, Belli, G, Beatrice, G, Florio, P, Innocenti, E, Magi, L, Civitelli, F, Nappi, L, Sorrentino, F, Silvestris, T, Indrio, F, Laforgia, N, Rizzo, V, La Rocca, M, Pradal, U, Memo, L, Diaz, C, Riscica, P, Bazzo, S, La Maida, N, Di Giorgi, A, Pellegrini, M, Ceccanti, M, Caruso, S, Ricci, G, Neri, I, Lana, S, Minutillo, A, Berretta, P, Busardo, F, Pichini, S, Camandona F., Vaccari L., Travan L., Maso G., Stampalija T., Zanazzo L., Pisana P., Driul L., Barbui E., Caissutti C., Valente E., Ricchi A., Bettiga E., Piccolo E., Pati M., Pedori S., Antonazzo P., Sottile G., Lo Faro F., Tini A., Massacesi M., Rapisarda C., Vivirito G., Pinna G., D'anna M., Klein L., Bucolo A., D'Anna R., Monaco C., La Ferrera G., Capobianco G., Olzai M. G., Angioni S., D'Alterio M. N., Serravalle P., Vicquery C., Scalchi S., Morando C., Meneghin M., Scapolan C., Maggino T., Guarinoni B., Cristina Napolitano G. M., De Vita M. G., Di Carlo C., Interlandi F., Bisceglia M., Michelangelo B., Arnulfo A., Finale E., Marozio L., Natali I., Grazia S. M., Staffler A., Tarani L., Coriale G., Messina M. P., D'Angelo A., Bonito M., Haass C., Capasso L., Raimondi F., De Bernardo G., Iacobelli P., Spadarella S., Enrica M., Rabuano R., Calzatini F., Bossi A., Aversa S., Prefumo F., Bellan C., Leone G., Ciammella M., Von-Wunster S., Liguori A., Ornaghi S., Fumagalli S., Sanguineti F., Gianola G., Cagnacci A., Amidani A., Sisto A., Di Marcello F., Santillo V., Di Bartolomeo C., Gerli S., Cagnoli G., Petrisano M., Pesce S., Di Lascio N., Falvino S., Appio P., Targiani V., Cavaliere A. F., Turrini I., Belli G., Beatrice G., Florio P., Innocenti E. D., Magi L., Civitelli F., Nappi L., Sorrentino F., Silvestris T., Indrio F., Laforgia N., Rizzo V., La Rocca M., Pradal U., Memo L., Diaz C., Riscica P., Bazzo S., La Maida N., Di Giorgi A., Pellegrini M., Ceccanti M., Caruso S., Ricci G., Neri I., Lana S., Minutillo A., Berretta P., Busardo F. P., Pichini S., Camandona, F, Vaccari, L, Travan, L, Maso, G, Stampalija, T, Zanazzo, L, Pisana, P, Driul, L, Barbui, E, Caissutti, C, Valente, E, Ricchi, A, Bettiga, E, Piccolo, E, Pati, M, Pedori, S, Antonazzo, P, Sottile, G, Lo Faro, F, Tini, A, Massacesi, M, Rapisarda, C, Vivirito, G, Pinna, G, D'Anna, M, Klein, L, Bucolo, A, D'Anna, R, Monaco, C, La Ferrera, G, Capobianco, G, Olzai, M, Angioni, S, D'Alterio, M, Serravalle, P, Vicquery, C, Scalchi, S, Morando, C, Meneghin, M, Scapolan, C, Maggino, T, Guarinoni, B, Cristina Napolitano, G, De Vita, M, Di Carlo, C, Interlandi, F, Bisceglia, M, Michelangelo, B, Arnulfo, A, Finale, E, Marozio, L, Natali, I, Grazia, S, Staffler, A, Tarani, L, Coriale, G, Messina, M, D'Angelo, A, Bonito, M, Haass, C, Capasso, L, Raimondi, F, De Bernardo, G, Iacobelli, P, Spadarella, S, Enrica, M, Rabuano, R, Calzatini, F, Bossi, A, Aversa, S, Prefumo, F, Bellan, C, Leone, G, Ciammella, M, Von-Wunster, S, Liguori, A, Ornaghi, S, Fumagalli, S, Sanguineti, F, Gianola, G, Cagnacci, A, Amidani, A, Sisto, A, Di Marcello, F, Santillo, V, Di Bartolomeo, C, Gerli, S, Cagnoli, G, Petrisano, M, Pesce, S, Di Lascio, N, Falvino, S, Appio, P, Targiani, V, Cavaliere, A, Turrini, I, Belli, G, Beatrice, G, Florio, P, Innocenti, E, Magi, L, Civitelli, F, Nappi, L, Sorrentino, F, Silvestris, T, Indrio, F, Laforgia, N, Rizzo, V, La Rocca, M, Pradal, U, Memo, L, Diaz, C, Riscica, P, Bazzo, S, La Maida, N, Di Giorgi, A, Pellegrini, M, Ceccanti, M, Caruso, S, Ricci, G, Neri, I, Lana, S, Minutillo, A, Berretta, P, Busardo, F, Pichini, S, Camandona F., Vaccari L., Travan L., Maso G., Stampalija T., Zanazzo L., Pisana P., Driul L., Barbui E., Caissutti C., Valente E., Ricchi A., Bettiga E., Piccolo E., Pati M., Pedori S., Antonazzo P., Sottile G., Lo Faro F., Tini A., Massacesi M., Rapisarda C., Vivirito G., Pinna G., D'anna M., Klein L., Bucolo A., D'Anna R., Monaco C., La Ferrera G., Capobianco G., Olzai M. G., Angioni S., D'Alterio M. N., Serravalle P., Vicquery C., Scalchi S., Morando C., Meneghin M., Scapolan C., Maggino T., Guarinoni B., Cristina Napolitano G. M., De Vita M. G., Di Carlo C., Interlandi F., Bisceglia M., Michelangelo B., Arnulfo A., Finale E., Marozio L., Natali I., Grazia S. M., Staffler A., Tarani L., Coriale G., Messina M. P., D'Angelo A., Bonito M., Haass C., Capasso L., Raimondi F., De Bernardo G., Iacobelli P., Spadarella S., Enrica M., Rabuano R., Calzatini F., Bossi A., Aversa S., Prefumo F., Bellan C., Leone G., Ciammella M., Von-Wunster S., Liguori A., Ornaghi S., Fumagalli S., Sanguineti F., Gianola G., Cagnacci A., Amidani A., Sisto A., Di Marcello F., Santillo V., Di Bartolomeo C., Gerli S., Cagnoli G., Petrisano M., Pesce S., Di Lascio N., Falvino S., Appio P., Targiani V., Cavaliere A. F., Turrini I., Belli G., Beatrice G., Florio P., Innocenti E. D., Magi L., Civitelli F., Nappi L., Sorrentino F., Silvestris T., Indrio F., Laforgia N., Rizzo V., La Rocca M., Pradal U., Memo L., Diaz C., Riscica P., Bazzo S., La Maida N., Di Giorgi A., Pellegrini M., Ceccanti M., Caruso S., Ricci G., Neri I., Lana S., Minutillo A., Berretta P., Busardo F. P., and Pichini S.

Published
2023

3. AB0573 REASONS FOR BREASTFEEDING AVOIDANCE: A MULTICENTER INSIGHT IN MOTHERS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Author

Foddai, S. G., primary, Radin, M., additional, Schreiber, K., additional, Cecchi, I., additional, Signorelli, F., additional, De Jesùs, G., additional, Aso, K., additional, Kono, M., additional, Urban, M. L., additional, Bacco, B., additional, Gallo Cassarino, S., additional, Lo Sardo, L., additional, Arbrile, M., additional, Barinotti, A., additional, Gómez-García, I., additional, Quaglia, M. I., additional, Tissera, Y., additional, Gervasoniuniversity of Turin, F., additional, Aguirre-Zamorano, M. Á., additional, Alba, P., additional, Benedetto, C., additional, Atsumi, T., additional, Amengual, O., additional, Emmi, G., additional, Andrade, D., additional, Marozio, L., additional, Roccatello, D., additional, and Sciascia, S., additional

Published
2023
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5. The first SARS-CoV-2 wave among pregnant women in Italy: results from a prospective population-based study

Author

Donati, S, Corsi, E, Maraschini, A, Salvatore, M, Baltaro, F, Boldrini, R, Bonassisa, S, Brunelli, R, Cagnacci, A, Casucci, P, Cataneo, I, Cetin, I, de Ambrosi, E, Manso, M, Fabiani, M, Fieni, S, Franchi, M, Iurlaro, E, Leo, L, Liberati, M, Sacchi, L, Livio, S, Locci, M, Marozio, L, Martini, C, Maso, G, Mecacci, F, Meloni, A, Mignuoli, A, Moresi, S, Patane, L, Perotti, F, Perrone, E, Prefumo, F, Ramenghi, L, Rusciani, R, Savasi, V, Schettini, S, Simeone, D, Soligo, M, Steinkasserer, M, Tateo, S, Ternelli, G, Tironi, R, Trojano, V, Vergani, P, Donati S., Corsi E., Maraschini A., Salvatore M. A., Baltaro F., Boldrini R., Bonassisa S., Brunelli R., Cagnacci A., Casucci P., Cataneo I., Cetin I., de Ambrosi E., Manso M. D., Fabiani M., Fieni S., Franchi M. P., Iurlaro E., Leo L., Liberati M., Sacchi L. L., Livio S., Locci M., Marozio L., Martini C., Maso G., Mecacci F., Meloni A., Mignuoli A. D., Moresi S., Patane L., Perotti F., Perrone E., Prefumo F., Ramenghi L., Rusciani R., Savasi V., Schettini S. C. A., Simeone D., Soligo M., Steinkasserer M., Tateo S., Ternelli G., Tironi R., Trojano V., Vergani P., Donati, S, Corsi, E, Maraschini, A, Salvatore, M, Baltaro, F, Boldrini, R, Bonassisa, S, Brunelli, R, Cagnacci, A, Casucci, P, Cataneo, I, Cetin, I, de Ambrosi, E, Manso, M, Fabiani, M, Fieni, S, Franchi, M, Iurlaro, E, Leo, L, Liberati, M, Sacchi, L, Livio, S, Locci, M, Marozio, L, Martini, C, Maso, G, Mecacci, F, Meloni, A, Mignuoli, A, Moresi, S, Patane, L, Perotti, F, Perrone, E, Prefumo, F, Ramenghi, L, Rusciani, R, Savasi, V, Schettini, S, Simeone, D, Soligo, M, Steinkasserer, M, Tateo, S, Ternelli, G, Tironi, R, Trojano, V, Vergani, P, Donati S., Corsi E., Maraschini A., Salvatore M. A., Baltaro F., Boldrini R., Bonassisa S., Brunelli R., Cagnacci A., Casucci P., Cataneo I., Cetin I., de Ambrosi E., Manso M. D., Fabiani M., Fieni S., Franchi M. P., Iurlaro E., Leo L., Liberati M., Sacchi L. L., Livio S., Locci M., Marozio L., Martini C., Maso G., Mecacci F., Meloni A., Mignuoli A. D., Moresi S., Patane L., Perotti F., Perrone E., Prefumo F., Ramenghi L., Rusciani R., Savasi V., Schettini S. C. A., Simeone D., Soligo M., Steinkasserer M., Tateo S., Ternelli G., Tironi R., Trojano V., and Vergani P.

Abstract

Introduction. This study aimed to estimate the incidence of SARS-CoV-2 infection among pregnant women during the first pandemic wave in Italy, and to describe CO-VID-19 disease characteristics and maternal and perinatal outcomes. Materials and methods. National population-based prospective cohort study collecting information on women with SARS-CoV-2 diagnosis, confirmed within 7 days from hospital admission. Results. The 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). Conclusions. During 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.

Published
2021

6. Childbirth care among sars-cov-2 positive women in Italy

Author

Donati, S, Corsi, E, Salvatore, M, Maraschini, A, Bonassisa, S, Casucci, P, Cataneo, I, Cetin, I, D'Aloja, P, Dardanoni, G, De Ambrosi, E, Ferrazzi, E, Fieni, S, Franchi, M, Gargantini, G, Iurlaro, E, Leo, L, Liberati, M, Livio, S, Locci, M, Marozio, L, Martini, C, Maso, G, Mecacci, F, Meloni, A, Mignuoli, A, Patane, L, Pellegrini, E, Perotti, F, Perrone, E, Prefumo, F, Ramenghi, L, Rusciani, R, Savasi, V, Schettini, S, Simeone, D, Simeone, S, Spinillo, A, Steinkasserer, M, Tateo, S, Ternelli, G, Tironi, R, Trojano, V, Vergani, P, Zullino, S, Donati S., Corsi E., Salvatore M. A., Maraschini A., Bonassisa S., Casucci P., Cataneo I., Cetin I., D'aloja P., Dardanoni G., De Ambrosi E., Ferrazzi E., Fieni S., Franchi M. P., Gargantini G., Iurlaro E., Leo L., Liberati M., Livio S., Locci M., Marozio L., Martini C., Maso G., Mecacci F., Meloni A., Mignuoli A. D., Patane L., Pellegrini E., Perotti F., Perrone E., Prefumo F., Ramenghi L., Rusciani R., Savasi V., Schettini S. C. A., Simeone D., Simeone S., Spinillo A., Steinkasserer M., Tateo S., Ternelli G., Tironi R., Trojano V., Vergani P., Zullino S., Donati, S, Corsi, E, Salvatore, M, Maraschini, A, Bonassisa, S, Casucci, P, Cataneo, I, Cetin, I, D'Aloja, P, Dardanoni, G, De Ambrosi, E, Ferrazzi, E, Fieni, S, Franchi, M, Gargantini, G, Iurlaro, E, Leo, L, Liberati, M, Livio, S, Locci, M, Marozio, L, Martini, C, Maso, G, Mecacci, F, Meloni, A, Mignuoli, A, Patane, L, Pellegrini, E, Perotti, F, Perrone, E, Prefumo, F, Ramenghi, L, Rusciani, R, Savasi, V, Schettini, S, Simeone, D, Simeone, S, Spinillo, A, Steinkasserer, M, Tateo, S, Ternelli, G, Tironi, R, Trojano, V, Vergani, P, Zullino, S, Donati S., Corsi E., Salvatore M. A., Maraschini A., Bonassisa S., Casucci P., Cataneo I., Cetin I., D'aloja P., Dardanoni G., De Ambrosi E., Ferrazzi E., Fieni S., Franchi M. P., Gargantini G., Iurlaro E., Leo L., Liberati M., Livio S., Locci M., Marozio L., Martini C., Maso G., Mecacci F., Meloni A., Mignuoli A. D., Patane L., Pellegrini E., Perotti F., Perrone E., Prefumo F., Ramenghi L., Rusciani R., Savasi V., Schettini S. C. A., Simeone D., Simeone S., Spinillo A., Steinkasserer M., Tateo S., Ternelli G., Tironi R., Trojano V., Vergani P., and Zullino S.

Abstract

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.

Published
2021

7. The first SARS-CoV-2 wave among pregnant women in Italy: results from a prospective population-based study

Author

Donati S., Corsi E., Maraschini A., Salvatore M. A., Baltaro F., Boldrini R., Bonassisa S., Brunelli R., Cagnacci A., Casucci P., Cataneo I., Cetin I., de Ambrosi E., Manso M. D., Fabiani M., Fieni S., Franchi M. P., Iurlaro E., Leo L., Liberati M., Sacchi L. L., Livio S., Locci M., Marozio L., Martini C., Maso G., Mecacci F., Meloni A., Mignuoli A. D., Moresi S., Patane L., Perotti F., Perrone E., Prefumo F., Ramenghi L., Rusciani R., Savasi V., Schettini S. C. A., Simeone D., Soligo M., Steinkasserer M., Tateo S., Ternelli G., Tironi R., Trojano V., Vergani P., Donati, S., Corsi, E., Maraschini, A., Salvatore, M. A., Baltaro, F., Boldrini, R., Bonassisa, S., Brunelli, R., Cagnacci, A., Casucci, P., Cataneo, I., Cetin, I., de Ambrosi, E., Manso, M. D., Fabiani, M., Fieni, S., Franchi, M. P., Iurlaro, E., Leo, L., Liberati, M., Sacchi, L. L., Livio, S., Locci, M., Marozio, L., Martini, C., Maso, G., Mecacci, F., Meloni, A., Mignuoli, A. D., Moresi, S., Patane, L., Perotti, F., Perrone, E., Prefumo, F., Ramenghi, L., Rusciani, R., Savasi, V., Schettini, S. C. A., Simeone, D., Soligo, M., Steinkasserer, M., Tateo, S., Ternelli, G., Tironi, R., Trojano, V., Vergani, P., Donati, S, Corsi, E, Maraschini, A, Salvatore, M, Baltaro, F, Boldrini, R, Bonassisa, S, Brunelli, R, Cagnacci, A, Casucci, P, Cataneo, I, Cetin, I, de Ambrosi, E, Manso, M, Fabiani, M, Fieni, S, Franchi, M, Iurlaro, E, Leo, L, Liberati, M, Sacchi, L, Livio, S, Locci, M, Marozio, L, Martini, C, Maso, G, Mecacci, F, Meloni, A, Mignuoli, A, Moresi, S, Patane, L, Perotti, F, Perrone, E, Prefumo, F, Ramenghi, L, Rusciani, R, Savasi, V, Schettini, S, Simeone, D, Soligo, M, Steinkasserer, M, Tateo, S, Ternelli, G, Tironi, R, Trojano, V, and Vergani, P

Subjects
SARS-CoV-2, Infectious, Cohort studies, Italy, Pregnancy outcome, COVID-19 Testing, Citizenship, Female, Humans, Pregnancy, Pregnant Women, Prospective Studies, COVID-19, Pregnancy Complications, Infectious, Pregnancy Complications, Cohort studie
Abstract

Introduction. This study aimed to estimate the incidence of SARS-CoV-2 infection among pregnant women during the first pandemic wave in Italy, and to describe CO-VID-19 disease characteristics and maternal and perinatal outcomes. Materials and methods. National population-based prospective cohort study collecting information on women with SARS-CoV-2 diagnosis, confirmed within 7 days from hospital admission. Results. The 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). Conclusions. During 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.

Published
2021

8. AB0458 DISEASE ACTIVITY AT CONCEPTION PREDICTS LUPUS FLARE UP TO 2 YEARS AFTER BIRTH: A MULTICENTRE LONG TERM FOLLOW-UP STUDY

Author

Radin, M., primary, Schreiber, K., additional, Cecchi, I., additional, Signorelli, F., additional, De Jesùs, G., additional, Aso, K., additional, Kono, M., additional, Urban, M. L., additional, Bacco, B., additional, Gallo Cassarino, S., additional, Lo Sardo, L., additional, Foddai, S. G., additional, Barinotti, A., additional, Gómez García, I., additional, Quaglia, M. I., additional, Tissera, Y., additional, Gervasoni, F., additional, Aguirre-Zamorano, M. Á., additional, Alba, P., additional, Benedetto, C., additional, Atsumi, T., additional, Amengual, O., additional, Emmi, G., additional, Andrade, D., additional, Marozio, L., additional, Roccatello, D., additional, and Sciascia, S., additional

Published
2022
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9. EP23.22: Endometriosis related carcinoma: a case report of a mesonephric adenocarcinoma of the ovary.

Author

Barbierato, I., Robba, E., Cosma, S., Bianquin, E., Benedetto, C., Sciarrone, A., Chiarle, G., Marozio, L., and Palmese, E.

Subjects
GENITALIA, CERVIX uteri, TRANSVAGINAL ultrasonography, OVARIES, ENDOMETRIOSIS, PELVIC pain
Abstract

This article discusses a rare form of cancer called mesonephric adenocarcinoma, which typically occurs in the uterine cervix but can also be associated with endometriosis when it occurs in the ovary. The case of a 76-year-old woman with a history of endometriosis is presented, who was diagnosed with mesonephric adenocarcinoma of the ovary. The article highlights the need for more research to define the ultrasound characteristics of this rare cancer and to consider it as a possible differential diagnosis when endometrioid cancer is suspected. The patient is currently undergoing chemotherapy. [Extracted from the article]

Published
2024
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10. Erratum: Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): Report of 1640 cases from EUROAPS registry (Rheumatology (2020) 59 (1306-1314) DOI: 10.1093/rheumatology/kez419)

Author

Alijotas-Reig J., Esteve-Valverde E., Ferrer-Oliveras R., Saez-Comet L., Lefkou E., Mekinian A., Belizna C., Ruffatti A., Hoxha A., Tincani A., Nalli C., Marozio L., Maina A., Espinosa G., Rios-Garces R., Cervera R., Carolis S. D., Monteleone G., Latino O., Udry S., Llurba E., Garrido-Gimenez C., Trespidi L., Gerosa M., Chighizola C. B., Rovere-Querini P., Canti V., Mayer-Pickel K., Tabacco S., Arnau A., Trape J., Ruiz-Hidalgo D., Sos L., Farran-Codina I., Alijotas-Reig, J., Esteve-Valverde, E., Ferrer-Oliveras, R., Saez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Hoxha, A., Tincani, A., Nalli, C., Marozio, L., Maina, A., Espinosa, G., Rios-Garces, R., Cervera, R., Carolis, S. D., Monteleone, G., Latino, O., Udry, S., Llurba, E., Garrido-Gimenez, C., Trespidi, L., Gerosa, M., Chighizola, C. B., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Tabacco, S., Arnau, A., Trape, J., Ruiz-Hidalgo, D., Sos, L., and Farran-Codina, I.

Abstract

In the original article, the affiliation of co-author Cecilia Beatrice Chighizola should have read: “Experimental Laboratory of Immunological and Rheumatologic Researches, Istituto Auxologico Italiano, IRCCS, Cusano Milanino, Milan, Italy”. These details have been corrected only in this corrigendum to preserve the published version of record.

Published
2021

11. Serial cervical length measurements after the 1st episode of threatened preterm labor improve prediction of spontaneous delivery prior to 37 weeks' gestation

Author

Chiossi, G, Facchinetti, F, Vergani, P, Di Tommaso, M, Marozio, L, Acaia, B, Pignatti, L, Locatelli, A, Spitaleri, M, Benedetto, C, Zaina, B, D'Amico, R, Chiossi, G, Facchinetti, F, Vergani, P, Di Tommaso, M, Marozio, L, Acaia, B, Pignatti, L, Locatelli, A, Spitaleri, M, Benedetto, C, Zaina, B, and D'Amico, R

Subjects
threatened preterm labor, spontaneous preterm birth, cervical length
Abstract

Objective: To assess whether repeat cervical-length (CL) measurement in women discharged from hospital after their first episode of threatened preterm labor can predict their risk of spontaneous preterm birth. Methods: This was a secondary analysis of a randomized controlled trial of maintenance tocolysis, in which CL was measured on transvaginal ultrasound at the time of hospital discharge and after 2, 4, 8 and 12 weeks, in women who remained undelivered after their first episode of threatened preterm labor. After univariate analysis, multivariate logistic regression analysis was used to assess whether CL < 10 mm at the time of hospital discharge or at any follow-up evaluation could predict spontaneous delivery prior to 37 weeks of gestation. Results: Of 226 women discharged after a diagnosis of threatened preterm labor, 57 (25.2%) delivered spontaneously prior to 37 weeks' gestation. The risk of spontaneous preterm birth was higher among women with CL < 10 mm at hospital discharge compared to those with CL ≥ 10 mm (adjusted odds ratio (aOR), 3.3; 95% CI, 1.2–9.2). Moreover, spontaneous preterm delivery was more common when CL < 10 mm was detected up to 2 weeks (aOR, 2.9; 95% CI, 1.1–7.3) or up to 4 weeks (aOR, 7.3; 95% CI, 2.3–22.8) post discharge, as compared with when CL was persistently ≥ 10 mm. The association was not significant when considering CL measurements at 8 weeks, and there was insufficient information to assess the effect of measurements obtained at 12 weeks. Conclusions: Women who remain undelivered after their first episode of threatened preterm labor continue to be at high risk of spontaneous preterm birth if their CL is below 10 mm at the time of hospital discharge or at any follow-up visit up to 4 weeks later. CL measurement could be included in the antenatal care of these women in order to stratify their risk of preterm birth, rationalize resource utilization and help clinicians improve pregnancy outcome. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Published
2021

12. Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from the EUROAPS registry

Author

Alijotas-Reig, J., Esteve-Valverde, E., Ferrer-Oliveras, R., Saez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Hoxha, A., Tincani, A., Nalli, C., Marozio, L., Maina, A., Espinosa, G., Rios-Garces, R., Cervera, R., Carolis, S. D., Monteleone, G., Latino, O., Udry, S., Llurba, E., Garrido-Gimenez, C., Trespidi, L., Gerosa, M., Chighizola, C. B., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Tabacco, S., Arnau, A., Trape, J., Ruiz-Hidalgo, D., Sos, L., and Farran-Codina, I.

Subjects
Adult, medicine.medical_specialty, medicine.drug_class, antiphospholipid, antiphospholipid antibodies, antiphospholipid syndrome, non-criteria antiphospholipid syndrome, obstetric antiphospholipid syndrome, outcomes, treatment, Antibodies, Antiphospholipid, Antiphospholipid Syndrome, Aspirin, Female, Humans, Live Birth, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Prospective Studies, Registries, Retrospective Studies, Treatment Outcome, Low molecular weight heparin, Antibodies, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Antiphospholipid syndrome, medicine, Pharmacology (medical), 030212 general & internal medicine, Prospective cohort study, 030203 arthritis & rheumatology, Obstetrics, business.industry, Retrospective cohort study, medicine.disease, Anti-thyroid autoantibodies, Clinical trial, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Live birth, business
Abstract

Objectives To compare clinical features, laboratory data and fetal-maternal outcomes between 1000 women with obstetric APS (OAPS) and 640 with aPL-related obstetric complications not fulfilling Sydney criteria (non-criteria OAPS, NC-OAPS). Methods This was a retrospective and prospective multicentre study from the European Registry on Obstetric Antiphospholipid Syndrome. Results A total of 1650 women with 5251 episodes, 3601 of which were historical and 1650 latest episodes, were included. Altogether, 1000 cases (OAPS group) fulfilled the Sydney classification criteria and 650 (NC-OAPS group) did not. Ten NC-OAPS cases were excluded for presenting thrombosis during follow-up. All cases were classified as category I (triple positivity or double positivity for aPL) or category II (simple positivity). Overall, aPL laboratory categories showed significant differences: 29.20% in OAPS vs 17.96% in NC-OAPS (P < 0.0001) for category I, and 70.8% in OAPS vs 82% in NC-OAPS (P < 0.0001) for category II. Significant differences were observed when current obstetric complications were compared (P < 0.001). However, major differences between groups were not observed in treatment rates, livebirths and thrombotic complications. In the NC-OAPS group, 176/640 (27.5%) did not fulfil Sydney clinical criteria (subgroup A), 175/640 (27.34%) had a low titre and/or non-persistent aPL positivity but did meet the clinical criteria (subgroup B) and 289/640 (45.15%) had a high aPL titre but did not fulfil Sydney clinical criteria (subgroup C). Conclusion Significant clinical and laboratory differences were found between groups. Fetal-maternal outcomes were similar in both groups when treated. These results suggest that we could improve our clinical practice with better understanding of NC-OAPS patients.

Published
2019
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13. Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from EUROAPS registry (vol 59, pg 1306, 2020)

Author

Alijotas-Reig, J, Esteve-Valverde, E, Ferrer-Oliveras, R, Saez-Comet, L, Lefkou, E, Mekinian, A, Belizna, C, Ruffatti, A, Hoxha, A, Tincani, A, Nalli, C, Marozio, L, Maina, A, Espinosa, G, Rios-Garces, R, Cervera, R, De Carolis, S, Monteleone, G, Latino, O, Udry, S, Llurba, E, Garrido-Gimenez, C, Trespidi, L, Gerosa, M, Chighizola, CB, Rovere-Querini, P, Canti, V, Mayer-Pickel, K, Tabacco, S, Arnau, A, Trape, J, Ruiz-Hidalgo, D, Sos, L, and Farran-Codina, I

Published
2021

14. Bleeding and antithrombotic therapy during pregnancy in women with poor aPL-related obstetric outcomes: A survey of 1075 cases from EUROAPS registry∗

Author

Alijotas-Reig, J., Esteve-Valverde, E., Ferrer-Oliveras, R., Saez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Tincani, A., Pardos-Gea, J., Nalli, C., Marozio, L., Espinosa, G., De Carolis, S., Latino, O., Sebastian, U., LLurba, E., Trespidi, L., Chighizola, C., Pengo, V., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Reshetnyak, T., Tabacco, S., Arnau, A., De Carolis S. (ORCID:0000-0002-5160-7609), Alijotas-Reig, J., Esteve-Valverde, E., Ferrer-Oliveras, R., Saez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Tincani, A., Pardos-Gea, J., Nalli, C., Marozio, L., Espinosa, G., De Carolis, S., Latino, O., Sebastian, U., LLurba, E., Trespidi, L., Chighizola, C., Pengo, V., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Reshetnyak, T., Tabacco, S., Arnau, A., and De Carolis S. (ORCID:0000-0002-5160-7609)

Abstract

BACKGROUND: The combination of low-dose aspirin (LDA) and low-molecular-weight heparin (LMWH) until the end of gestation are the currently the accepted standard of care for the treatment of antiphospholipid-related obstetric disorders. In refractory cases, hydroxychloroquine (HCQ) can be added to this standard of care. OBJECTIVE: To evaluate the haemostatic safety of LDA and LMWH (medium to high prophylactic doses) during pregnancy and the puerperium in women with both full-blown obstetric antiphospholipid syndrome (OAPS) (Sydney criteria) and noncriteria - incomplete - OAPS. STUDY DESIGN: Retrospective/prospective multicentre observational study. Obstetric background, laboratory categories, delivery mode, antithrombotic regimens and bleeding complications were compared. SETTING: A total of 30 tertiary European hospitals. PATIENTS: Mainly, Caucasian/Arian pregnant women were included. Other ethnicities were minimally present. Women were controlled throughout pregnancy and puerperium. MAIN OUTCOME MEASURES: The primary end-point was to evaluate the number of major and minor haemorrhagic complications in this cohort of women. Neuraxial anaesthetic bleeding complications were particularly assessed. Secondly, we aimed to compare local/general bleeding events between groups. RESULTS: We studied 1650 women, of whom 1000 fulfilled the Sydney criteria of the OAPS and 650 did not (noncriteria OAPS). Data on antithrombotic-related complications were available in 1075 cases (65.15%). Overall, 53 (4.93%) women had bleeding complications, with 34 being considered minor (3.16%) and 19 major (1.76%). Neither obstetric complications nor laboratory categories were bleeding-related. Assisted vaginal delivery and caesarean section were related to local haemorrhage. Heparin doses and platelet count were not associated with major bleeding. CONCLUSIONS: LDA and medium to high prophylactic LMWH during pregnancy in women with full-blown OAPS/noncriteria OAPS are safe. A slight increase in

Published
2021

16. POS0751 COMORBIDITY AND LONG-TERM OUTCOME IN PATIENTS WITH CONGENITAL HEART BLOCK: PRELIMINARY DATA OF THE ITALIAN REGISTRY ON THE IMMUNE-MEDIATED CONGENITAL HEART BLOCK

Author

Fredi, M., primary, Rizzo, G., additional, Andreoli, L., additional, Bacco, B., additional, Bertero, T., additional, Bortoluzzi, A., additional, Ceccarelli, F., additional, Cimaz, R., additional, Conigliaro, P., additional, Corradi, F., additional, De Vita, S., additional, DI Poi, E., additional, Elefante, E., additional, Emmi, G., additional, Gerosa, M., additional, Govoni, M., additional, Hoxha, A., additional, Lojacono, A., additional, Marrani, E., additional, Marozio, L., additional, Mathieu, A., additional, Mosca, M., additional, Melissa, P., additional, Picchi, C., additional, Piga, M., additional, Priori, R., additional, Ramoni, V., additional, Ruffatti, A., additional, Simonini, G., additional, Tani, C., additional, Tonello, M., additional, Trespidi, L., additional, Urban, M. L., additional, Vezzoli, M., additional, Zatti, S., additional, Calza, S., additional, Brucato, A., additional, Franceschini, F., additional, and Tincani, A., additional

Published
2021
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17. Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from the EUROAPS registry

Author

Alijotas-Reig, J, Esteve-Valverde, E, Ferrer-Oliveras, R, Saez-Comet, L, Lefkou, E, Mekinian, A, Belizna, C, Ruffatti, A, Hoxha, A, Tincani, A, Nalli, C, Marozio, L, Maina, A, Espinosa, G, Rios-Garces, R, Cervera, R, De Carolis, S, Monteleone, G, Latino, O, Udry, S, Llurba, E, Garrido-Gimenez, C, Trespidi, L, Gerosa, M, Chighizola, CB, Rovere-Querini, P, Canti, V, Mayer-Pickel, K, Tabacco, S, Arnau, A, Trape, J, Ruiz-Hidalgo, D, Sos, L, Farran-Codina, I, and EUROAPS Study Grp

Subjects
antiphospholipid, treatment, antiphospholipid antibodies, non-criteria antiphospholipid syndrome, obstetric antiphospholipid syndrome, outcomes, antiphospholipid syndrome
Abstract

Objectives. To compare clinical features, laboratory data and fetal-maternal outcomes between 1000 women with obstetric APS (OAPS) and 640 with aPL-related obstetric complications not fulfilling Sydney criteria (non-criteria OAPS, NC-OAPS). Methods. This was a retrospective and prospective multicentre study from the European Registry on Obstetric Antiphospholipid Syndrome. Results. A total of 1650 women with 5251 episodes, 3601 of which were historical and 1650 latest episodes, were included. Altogether, 1000 cases (OAPS group) fulfilled the Sydney classification criteria and 650 (NC-OAPS group) did not. Ten NC-OAPS cases were excluded for presenting thrombosis during follow-up. All cases were classified as category I (triple positivity or double positivity for aPL) or category II (simple positivity). Overall, aPL laboratory categories showed significant differences: 29.20% in OAPS vs 17.96% in NC-OAPS (P < 0.0001) for category I, and 70.8% in OAPS vs 82% in NC-OAPS (P < 0.0001) for category II. Significant differences were observed when current obstetric complications were compared (P < 0.001). However, major differences between groups were not observed in treatment rates, livebirths and thrombotic complications. In the NC-OAPS group, 176/640 (27.5%) did not fulfil Sydney clinical criteria (subgroup A), 175/640 (27.34%) had a low titre and/or non-persistent aPL positivity but did meet the clinical criteria (subgroup B) and 289/640 (45.15%) had a high aPL titre but did not fulfil Sydney clinical criteria (subgroup C). Conclusion. Significant clinical and laboratory differences were found between groups. Fetal-maternal outcomes were similar in both groups when treated. These results suggest that we could improve our clinical practice with better understanding of NC-OAPS patients.

Published
2020

19. EP24.16: Malignant transformation of a typical endometrioma through the years: a case report.

Author

Robba, E., Barbierato, I., Bianquin, E., Chiarle, G., Palmese, E., Benedetto, C., Marozio, L., Cosma, S., and Sciarrone, A.

Subjects
PELVIC pain, OVARIAN cysts, OLDER patients, ENDOMETRIOSIS, PATHOLOGY, OVARIAN cancer
Abstract

This article discusses the potential for malignant transformation in endometriomas, which are typically benign. The study presents a case of a 58-year-old patient with a history of endometriosis who experienced the transformation of a typical endometrioma into endometrioid cancer. The patient had regular ultrasound examinations, and the changes in the characteristics of the cyst over time were observed. The authors suggest that monitoring endometriomas in menopause, even if they are small, is important, and further research should be conducted to identify potential signs of malignant transformation before it occurs. [Extracted from the article]

Published
2024
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20. EP20.26: Recurrent invasive mole within the myometrium.

Author

Robba, E., Barbierato, I., Bianquin, E., Chiarle, G., Palmese, E., Benedetto, C., Marozio, L., Cosma, S., and Sciarrone, A.

Subjects
GESTATIONAL trophoblastic disease, UTERINE hemorrhage, SYMPTOMS, MYOMETRIUM, METRORRHAGIA, MOLAR pregnancy
Abstract

This article, titled "EP20.26: Recurrent invasive mole within the myometrium," discusses the case of a 32-year-old woman who had a previous invasive mole after a molar pregnancy. The woman presented with heavy vaginal bleeding and a hyperechoic myometrial mass in the posterior uterine wall. The tumor board considered her high risk and started her on EMACO treatment. After three cycles, the mass reduced in size and the HCG level decreased. The article emphasizes the importance of laboratory testing and ultrasound examinations in evaluating the response to treatment. [Extracted from the article]

Published
2024
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21. AB0457 OBSTETRICAL OUTCOME AND TREATMENTS DURING PREGNANCY IN SERONEGATIVE PRIMARY APS: DATA FROM EUROPEAN RETROSPECTIVE STUDY

Author

Abisror, N., primary, Nguyen, Y., additional, Marozio, L., additional, Esteve-Valverde, E., additional, Udry, S., additional, Pleguezuelo, D. E., additional, Billoir, P., additional, Mayer-Pickel, K., additional, Urbanski, G., additional, Zigon, P., additional, De Moreuil, C., additional, Hoxha, A., additional, Bezanahary, H., additional, Carbillon, L., additional, Kayem, G., additional, Bornes, M., additional, Yelnik, C., additional, Johanet, C., additional, Nicaise Roland, P., additional, Lambert, M., additional, Salle, V., additional, Latino, O., additional, Hachlla, E., additional, Benedetto, C., additional, Benhamou, Y., additional, Alijotas-Reig, J., additional, Fain, O., additional, and Mekinian, A., additional

Published
2020
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24. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases

Author

Alijotas-Reig, J., Esteve-Valverde, E., Ferrer-Oliveras, R., Sáez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Tincani, A., Marozio, L., Espinosa, G., Cervera, R., de Carolis, S., Latino, O., LLurba, E., Meroni, P.L., Chighizola, C.B., Gerosa, M., Pengo, V., Lundelin, K., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Reshetnyak, T., Hoxha, A., Tabacco, S., Stojanovich, L., Gogou, V., Varoudis, A., Arnau, A., Ruiz-Hidalgo, D., Trapé, J., Sos, L., Stoppani, C., Martí-Cañamares, A., Farran-Codina, I., and for, the, EUROAPS, Study, Group

Abstract

Aim: To analyse the clinical features, laboratory data and foetal-maternal outcomes, and follow them up on a cohort of 1000 women with obstetric antiphospholipid syndrome (OAPS). Methods: The European Registry of OAPS became a registry within the framework of the European Forum on Antiphospholipid Antibody projects and was placed on a website in June 2010. Thirty hospitals throughout Europe have collaborated to carry out this registry. Cases with obstetric complaints related to antiphospholipid antibodies (aPL) who tested positive for aPL at least twice were included prospectively and retrospectively. The seven-year survey results are reported. Results: 1000 women with 3553 episodes were included of which 2553 were historical and 1000 were latest episodes. All cases fulfilled the Sydney classification criteria. According to the laboratory categories, 292 (29.2%) were in category I, 357 (35.7%) in IIa, 224 (22.4%) in IIb and 127 (12.7%) in IIc. Miscarriages were the most prevalent clinical manifestation in 386 cases (38.6%). Moreover, the presence of early preeclampsia (PE) and early foetal growth restriction (FGR) appeared in 181 (18.1%) and 161 (16.1%), respectively. In this series, 448 (44.8%) women received the recommended OAPS treatment. Patients with recommended treatment had a good live-birth rate (85%), but worse results (72.4%) were obtained in patients with any treatment (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH) not on recommended schedule, while patients with no treatment showed a poor birth rate (49.6%). Conclusion: In this series, recurrent miscarriage is the most frequent poor outcome. To avoid false-negative diagnoses, all laboratory category subsets were needed. OAPS cases have very good foetal-maternal outcomes when treated. Results suggest that we were able to improve our clinical practice to offer better treatment and outcomes to OAPS patients.

Published
2019

25. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases

Author

Alijotas-Reig, J, Esteve-Valverde, E, Ferrer-Oliveras, R, Lefkou, E, Belizna, C, Ruffatti, A, Tincani, A, Marozio, L, Espinosa, G, Rios-Garces, R, De Carolis, S, Latino, O, Llurba, E, Chighizola, CB, Rovere-Querini, P, Canti, V, Reshetnyak, T, Tabacco, S, Stojanovich, L, Gogou, V, Varoudis, A, Arnau, A, Ruiz-Hidalgo, D, Trape, J, Marti-Canamares, A, Bertero, MT, Kuzenko, A, Coloma, E, Meroni, PL, Ruano, A, del Ross, T, Melnychuk, T, Pengo, V, Gerosa, M, Fredi, M, Lundelin, K, Picardo, E, Cervera, R, Mekinian, A, Toth, B, Saez-Comet, L, Bremme, K, Mayer-Pickel, K, Gil-Aguado, A, Sos, L, Stoppani, C, Hoxha, A, and Farran-Codina, I

Subjects
Antiphospholipid antibody, Registry, Obstetric antiphospholipid syndrome, Pregnancy autoimmune disorders, Antiphospholipid syndrome
Abstract

Aim: To analyse the clinical features, laboratory data and foetal-maternal outcomes, and follow them up on a cohort of 1000 women with obstetric antiphospholipid syndrome (OAPS). Methods: The European Registry of OAPS became a registry within the framework of the European Forum on Antiphospholipid Antibody projects and was placed on a website in June 2010. Thirty hospitals throughout Europe have collaborated to carry out this registry. Cases with obstetric complaints related to antiphospholipid antibodies (aPL) who tested positive for aPL at least twice were included prospectively and retrospectively. The seven-year survey results are reported. Results: 1000 women with 3553 episodes were included of which 2553 were historical and 1000 were latest episodes. All cases fulfilled the Sydney classification criteria. According to the laboratory categories, 292 (29.2%) were in category I, 357 (35.7%) in Era, 224 (22.4%) in IIb and 127 (12.7%) in IIc. Miscarriages were the most prevalent clinical manifestation in 386 cases (38.6%). Moreover, the presence of early preeclampsia (PE) and early foetal growth restriction (FGR) appeared in 181 (18.1%) and 161 (16.1%), respectively. In this series, 448 (44.8%) women received the recommended OAPS treatment. Patients with recommended treatment had a good live-birth rate (85%), but worse results (72.4%) were obtained in patients with any treatment (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH) not on recommended schedule, while patients with no treatment showed a poor birth rate (49.6%). Conclusion: In this series, recurrent miscarriage is the most frequent poor outcome. To avoid false-negative diagnoses, all laboratory category subsets were needed. OAPS cases have very good foetal-maternal outcomes when treated. Results suggest that we were able to improve our clinical practice to offer better treatment and outcomes to OAPS patients.

Published
2019

29. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases

Author

Alijotas-Reig, Jaume, Esteve-Valverde, Enrique, Ferrer-Oliveras, R., Sáez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Tincani, A., Marozio, L., Espinosa, G., Cervera, R., De Carolis, Sara, Latino, O., Llurba, E., Meroni, P. L., Chighizola, C. B., Gerosa, M., Pengo, V., Lundelin, K., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Reshetnyak, T., Hoxha, A., Tabacco, S., Stojanovich, L., Gogou, V., Varoudis, A., Arnau, A., Ruiz-Hidalgo, D., Trapé, J., Sos, L., Stoppani, C., Martí-Cañamares, A., Farran-Codina, Inmaculada, de Carolis, S. (ORCID:0000-0002-5160-7609), Alijotas-Reig, Jaume, Esteve-Valverde, Enrique, Ferrer-Oliveras, R., Sáez-Comet, L., Lefkou, E., Mekinian, A., Belizna, C., Ruffatti, A., Tincani, A., Marozio, L., Espinosa, G., Cervera, R., De Carolis, Sara, Latino, O., Llurba, E., Meroni, P. L., Chighizola, C. B., Gerosa, M., Pengo, V., Lundelin, K., Rovere-Querini, P., Canti, V., Mayer-Pickel, K., Reshetnyak, T., Hoxha, A., Tabacco, S., Stojanovich, L., Gogou, V., Varoudis, A., Arnau, A., Ruiz-Hidalgo, D., Trapé, J., Sos, L., Stoppani, C., Martí-Cañamares, A., Farran-Codina, Inmaculada, and de Carolis, S. (ORCID:0000-0002-5160-7609)

Abstract

Aim: To analyse the clinical features, laboratory data and foetal-maternal outcomes, and follow them up on a cohort of 1000 women with obstetric antiphospholipid syndrome (OAPS). Methods: The European Registry of OAPS became a registry within the framework of the European Forum on Antiphospholipid Antibody projects and was placed on a website in June 2010. Thirty hospitals throughout Europe have collaborated to carry out this registry. Cases with obstetric complaints related to antiphospholipid antibodies (aPL) who tested positive for aPL at least twice were included prospectively and retrospectively. The seven-year survey results are reported. Results: 1000 women with 3553 episodes were included of which 2553 were historical and 1000 were latest episodes. All cases fulfilled the Sydney classification criteria. According to the laboratory categories, 292 (29.2%) were in category I, 357 (35.7%) in IIa, 224 (22.4%) in IIb and 127 (12.7%) in IIc. Miscarriages were the most prevalent clinical manifestation in 386 cases (38.6%). Moreover, the presence of early preeclampsia (PE) and early foetal growth restriction (FGR) appeared in 181 (18.1%) and 161 (16.1%), respectively. In this series, 448 (44.8%) women received the recommended OAPS treatment. Patients with recommended treatment had a good live-birth rate (85%), but worse results (72.4%) were obtained in patients with any treatment (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH) not on recommended schedule, while patients with no treatment showed a poor birth rate (49.6%). Conclusion: In this series, recurrent miscarriage is the most frequent poor outcome. To avoid false-negative diagnoses, all laboratory category subsets were needed. OAPS cases have very good foetal-maternal outcomes when treated. Results suggest that we were able to improve our clinical practice to offer better treatment and outcomes to OAPS patients.

Published
2019

31. Progestogens for maintenance tocolysis in women with a short cervix

Author

Facchinetti, F, Di Tommaso, M, Marozio, L, Acaia, B, Vicini, R, Pignatti, L, Spitaleri, M, Benedetto, C, Zaina, B, D'Amico, R., VERGANI, PATRIZIA, LOCATELLI, ANNA, Facchinetti, F, Vergani, P, Di Tommaso, M, Marozio, L, Acaia, B, Vicini, R, Pignatti, L, Locatelli, A, Spitaleri, M, Benedetto, C, Zaina, B, and D'Amico, R

Subjects
Adult, Intramuscular, Intravaginal, Obstetrics and Gynecology, Cervix Uteri, Progestogens, MaintenanceTocolysis, Short Cervix, Administration, Intravaginal, Female, Humans, Hydroxyprogesterones, Injections, Intramuscular, Pregnancy, Premature Birth, Treatment Outcome, Ultrasonography, Prenatal, Injections, Administration, Prenatal, Ultrasonography
Abstract

OBJECTIVE: To assess the efficacy of progestogens for maintenance tocolysis in women undelivered after their first preterm labor episode. METHODS: Women with singleton pregnancies between 22 0/7 and 31 6/7 weeks of gestation with arrested preterm labor and a cervical length 25 mm or less at hospital discharge were eligible. Patients with a previous preterm birth were excluded. In a randomized controlled trial conducted in five university hospitals, women were randomized to receive vaginal progesterone (200 mg per day) or intramuscular 17α-hydroxyprogesterone caproate (341 mg per week) or to an observation groups (control group). The primary outcome was the proportion of women with preterm birth at less than 37 weeks of gestation. A sample size of 160 per group (n=480) was planned to compare vaginal progesterone and 17ahydroxyprogesterone caproate groups with those in the control group. The sample size estimation was based on the hypothesis that the risk of experiencing preterm birth in the control group would be 30% and that 17α-hydroxyprogesterone caproate or progesterone would decrease this risk to 15%. A P value of ≤.025 was defined as statistically significant. At planned interim analysis (n=254), the trial was stopped for futility. RESULTS: Between July 2010 and June 2015, 257 women were eligible and 254 were subsequently randomly assigned to vaginal progesterone (n=86), 17α-hydroxyprogesterone caproate (n=87), or observation (n=81). Nineteen (8%) were excluded from the analysis because they either dropped out or information was missing, leaving 235 women available for analysis. Demographic characteristics were similar across groups. The preterm birth rate did not differ significantly between groups: 23% in the 17a-hydroxyprogesterone caproate group, 39% in the vaginal progesterone group, and 22% in the women in the control group (P=.949 for 17a-hydroxyprogesterone caproate compared with the women in the control group and P=.027 for vaginal progesterone compared with women in the control group). CONCLUSION: The use of progestogens for maintenance tocolysis in women with a short cervix did not reduce the rate of preterm birth.

Published
2017

32. Meta-analysis of low-molecular-weight heparin to prevent recurrent placenta-mediated pregnancy complications

Author

Rodger, MA, Carrier, M, Le Gal, G, Martinelli, I, Perna, A, Rey, E, de Vries, JI, Gris, JC, Chauleur, C, Molinari, N, Mares, P, Fabbro Peray, P, Quere, I, Lefrant, JY, Haddad, B, Dauzat, M, van Pampus, MG, Hague, WM, Bezemerand, PD, Joosten, JH, Ruggenenti, P, Cetin, I, Pardi, G, Acaia, B, Facchinetti, F, Sala, G, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, PM, Garneau, P, David, M, Gauthier, R, Leduc, L, Michon, N, Morin, F, Demers, C, Kahn, SR, Magee, LA, VERGANI, PATRIZIA, Thrombosis Program, University of Ottawa [Ottawa], Clinical Epidemiology Program (PSW), The Ottawa Health Research Institute, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Obstetrics and gynaecology, MOVE Research Institute, Movement Behavior, Research Institute MOVE, Rodger, M, Carrier, M, Le Gal, G, Martinelli, I, Perna, A, Rey, E, de Vries, J, Gris, J, Chauleur, C, Molinari, N, Mares, P, Fabbro Peray, P, Quere, I, Lefrant, J, Haddad, B, Dauzat, M, van Pampus, M, Hague, W, Bezemerand, P, Joosten, J, Ruggenenti, P, Cetin, I, Pardi, G, Vergani, P, Acaia, B, Facchinetti, F, Sala, G, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, P, Garneau, P, David, M, Gauthier, R, Leduc, L, Michon, N, Morin, F, Demers, C, Kahn, S, and Magee, L

Subjects
Relative risk reduction, medicine.medical_specialty, Placenta Diseases, medicine.drug_class, MED/40 - GINECOLOGIA E OSTETRICIA, [SDV]Life Sciences [q-bio], Immunology, Low molecular weight heparin, 030204 cardiovascular system & hematology, Biochemistry, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Meta-Analysis as Topic, Pre-Eclampsia, SDG 3 - Good Health and Well-being, MED/15 - MALATTIE DEL SANGUE, law, Pregnancy, Placenta, medicine, Secondary Prevention, Humans, reproductive and urinary physiology, 030219 obstetrics & reproductive medicine, Obstetrics, business.industry, Infant, Newborn, Cell Biology, Hematology, Heparin, Heparin, Low-Molecular-Weight, medicine.disease, 3. Good health, Pregnancy Complications, medicine.anatomical_structure, recurrent pregnancy complications, low-molecular-weight heparin, Relative risk, Meta-analysis, Female, business, medicine.drug
Abstract

A 35-year-old woman with recurrent severe placenta-mediated pregnancy complications in her 2 pregnancies asks: Will low-molecular-weight heparin help prevent recurrent placenta-mediated pregnancy complications in my next pregnancy? We performed a meta-analysis of randomized controlled trials (RCTs) comparing low-molecular-weight heparin (LMWH) vs no LMWH for the prevention of recurrent placenta-mediated pregnancy complications. We identified six RCTs that included a total of 848 pregnant women with prior placenta-mediated pregnancy complications. The primary outcome was a composite of pre-eclampsia (PE), birth of a small-for-gestational-age (SGA) newborn (20 weeks. Overall, 67 (18.7%) of 358 of women being given prophylactic LMWH had recurrent severe placenta-mediated pregnancy complications compared with 127 (42.9%) of 296 women with no LMWH (relative risk reduction, 0.52; 95% CI, 0.32 to 0.86; P = .01; I2, 69%, indicating moderate heterogeneity). We identified similar relative risk reductions with LMWH for individual outcomes, including any PE, severe PE, SGA

Published
2014
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33. High dose antithrombin supplementation in early preeclampsia: A randomized, double blind, placebo-controlled study

Author

D'Angelo, A, Valsecchi, L, AT III-Early Preeclampsia Study Group, Sampietro, F, Facchinetti, F, Marchesoni, D, Lovotti, M, Frusca, T, Telloli, P, Marozio, L, Raffaelli, R, and Bacci, M.

Subjects
Adult, Relative risk reduction, medicine.medical_specialty, Antithrombin, Early preeclampsia, Antithrombin III, Population, Placebo-controlled study, Placebo, Antithrombins, Preeclampsia, preeclampsia, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Pre-Eclampsia, Pregnancy, Internal medicine, Composite perinatal morbidity, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, education, education.field_of_study, 030219 obstetrics & reproductive medicine, business.industry, Obstetrics, Infant, Newborn, Infant, Hematology, Newborn, Placebo Effect, medicine.disease, D-dimer, Proteinuria, Female, Treatment Outcome, Relative risk, business, medicine.drug
Abstract

Introduction Antithrombin levels are often reduced in preeclampsia and infusion of antithrombin concentrates has been reported to prolong gestation in severe preeclampsia. We aimed to evaluate efficacy and safety of high-dose antithrombin (ATIII) supplementation in patients with single pregnancies and preeclampsia occurring before 30 weeks of gestation. Materials and methods In November 2004 a double-blind, placebo-controlled trial (code KB033) was started in 13 Italian centers. The planned sample size was of 240 patients (intention-to-treat, ITT population) to detect a 30% relative risk reduction of the primary endpoint, composite perinatal morbidity. Eligible patients were randomized to high dose AT (3000 IU/daily, ATIII Kedrion S.p.A., Italy), or placebo (1% glycine) for 7 days or less until delivery, whichever came first. The per-protocol (PP) population was restricted to patients receiving at least two days of treatment. Results The study was terminated by the sponsor in October 2007 after the enrolment of 38 evaluable patients – 20 randomized to high dose AT and 18 to placebo, 27 treated for 2 days or more – out of 164 screened patients. Enrolment failures were mainly represented by requirement for immediate delivery and consent refusal (91 patients). The primary endpoint occurred in 15 of 38 patients (39.5%), with a relative risk in the AT arm of 0.85 (95% CI 0.42–1.75) and 0.79 (95% CI 0.30-2.11) in the ITT and PP populations, respectively. Living neonates in the two arms had similar weight at birth, Apgar scores, and duration of hospitalization in neonatal ICU. In mothers, AT supplementation was associated with reduced blood loss at delivery and with surrogate laboratory markers (LDH, d -dimer). Conclusions The results of this markedly underpowered trial, albeit suggestive of a potential maternal benefit, cannot support high-dose AT supplementation to improve fetal/neonatal outcomes in early preeclampsia.

Published
2016
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34. Bedside diagnosis of two major clinical phenotypes of hypertensive disorders of pregnancy

Author

Ferrazzi, E, Zullino, S, Stampalija, T, Vener, C, Cavoretto, P, Gervasi, Mt, Vergani, P, Mecacci, F, Marozio, L, Oggé, G, Algeri, P, Ruffatti, A, Milani, S, Todros, T, Ferrazzi, E, Zullino, S, Stampalija, T, Vener, C, Cavoretto, P, Gervasi, M, Vergani, P, Mecacci, F, Marozio, L, Oggè, G, Algeri, P, Ruffatti, A, Milani, S, Todros, T, Gervasi, Mt, and Oggé, G

Subjects
Adult, intrauterine growth restriction, hypertension, pre-eclampsia, Intrauterine growth restriction, Gestational Age, Ultrasonography, Prenatal, metabolic syndrome, Doppler velocimetry, IUGR, Pregnancy, Tertiary Care Centers, Nuclear Medicine and Imaging, Abdomen, Hypertension, Metabolic syndrome, Pre-eclampsia, Radiological and Ultrasound Technology, Medicine (all), Reproductive Medicine, Radiology, Nuclear Medicine and Imaging, Obstetrics and Gynecology, Birth Weight, Humans, pregnancy, Retrospective Studies, Fetal Growth Retardation, Infant, Newborn, Pregnancy Outcome, Ultrasonography, Doppler, Hypertension, Pregnancy-Induced, Uterine Artery, Point-of-Care Testing, Female, Radiology
Abstract

To investigate the hypothesis that fetal abdominal circumference (AC) and uterine artery (UtA) Doppler pulsatility index (PI) could be used to select two homogeneous subgroups of women affected by hypertensive disorders of pregnancy (HDP), characterized by the coexistence of maternal hypertension with and without intrauterine growth restriction (IUGR).This was a multicenter retrospective study of cases affected by HDP in whom fetal AC and UtA-PI had been measured at admission to fetomaternal medicine units. Maternal characteristics, pregnancy complications and outcome were recorded. These data allowed us to model the characteristics of fetal growth in cases affected by HDP, and to design composite indicators of risk factors for maternal metabolic syndrome and of severity for maternal functional organ damage.Measurements of fetal AC and UtA-PI allowed us to define a group of HDP cases with appropriate-for-gestational-age (AGA) fetuses (HDP-AGA), diagnosed by normal fetal AC and UtA-PI (n = 205), and a group of HDP cases with IUGR fetuses (HDP-IUGR), diagnosed by fetal AC 5(th) centile and UtA-PI 95(th) centile (n = 124). Curves fitted to the birth weights of these two groups were significantly different, but gestational age at admission for HDP ( 34 or ≥ 34 weeks) did not show an independent association with birth weight. When birth weight was expressed as a Z-score with respect to local reference charts, the average corresponded to the 6(th) and 48(th) centiles, respectively. The occurrence of HDP-AGA (as compared with HDP-IUGR) was significantly associated with risk factors for maternal metabolic syndrome (odds ratio, 2.79 (95% CI, 1.57-4.97)), independent of gestational age. The same risk factors yielded non-significant odds ratios for the development of late-onset (vs early-onset) HDP. Women with HDP-IUGR had worse clinical outcomes.This study provides new information based on simple prenatal bedside examinations that might help to differentiate HDP-IUGR from HDP-AGA fetuses. These groups are associated with different fetal growth patterns and risk factors, independent of gestational age at onset of the disease. Copyright © 2015 ISUOG. Published by John WileySons Ltd.

Published
2016

35. Serial cervical-length measurements after first episode of threatened preterm labor improve prediction of spontaneous delivery prior to 37 weeks' gestation.

Author

Chiossi, G., Facchinetti, F., Vergani, P., Di Tommaso, M., Marozio, L., Acaia, B., Pignatti, L., Locatelli, A., Spitaleri, M., Benedetto, C., Zaina, B., D'Amico, R., and PROTECT Collaborative Group

Subjects
PREMATURE labor, PREGNANCY outcomes, PREGNANCY, PRENATAL care, HOSPITAL admission & discharge, RESEARCH, PREMATURE infants, PRENATAL diagnosis, CLINICAL trials, PREDICTIVE tests, THIRD trimester of pregnancy, RESEARCH methodology, REGRESSION analysis, GESTATIONAL age, MEDICAL cooperation, EVALUATION research, COMPARATIVE studies, RANDOMIZED controlled trials, FETAL ultrasonic imaging, DISCHARGE planning
Abstract

Objective: To assess whether repeat cervical-length (CL) measurement in women discharged from hospital after their first episode of threatened preterm labor can predict their risk of spontaneous preterm birth.Methods: This was a secondary analysis of a randomized controlled trial of maintenance tocolysis, in which CL was measured on transvaginal ultrasound at the time of hospital discharge and after 2, 4, 8 and 12 weeks, in women who remained undelivered after their first episode of threatened preterm labor. After univariate analysis, multivariate logistic regression analysis was used to assess whether CL < 10 mm at the time of hospital discharge or at any follow-up evaluation could predict spontaneous delivery prior to 37 weeks of gestation.Results: Of 226 women discharged after a diagnosis of threatened preterm labor, 57 (25.2%) delivered spontaneously prior to 37 weeks' gestation. The risk of spontaneous preterm birth was higher among women with CL < 10 mm at hospital discharge compared to those with CL ≥ 10 mm (adjusted odds ratio (aOR), 3.3; 95% CI, 1.2-9.2). Moreover, spontaneous preterm delivery was more common when CL < 10 mm was detected up to 2 weeks (aOR, 2.9; 95% CI, 1.1-7.3) or up to 4 weeks (aOR, 7.3; 95% CI, 2.3-22.8) post discharge, as compared with when CL was persistently ≥ 10 mm. The association was not significant when considering CL measurements at 8 weeks, and there was insufficient information to assess the effect of measurements obtained at 12 weeks.Conclusions: Women who remain undelivered after their first episode of threatened preterm labor continue to be at high risk of spontaneous preterm birth if their CL is below 10 mm at the time of hospital discharge or at any follow-up visit up to 4 weeks later. CL measurement could be included in the antenatal care of these women in order to stratify their risk of preterm birth, rationalize resource utilization and help clinicians improve pregnancy outcome. © 2020 International Society of Ultrasound in Obstetrics and Gynecology. [ABSTRACT FROM AUTHOR]

Published
2021
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37. THU0635 Pregnancy outcomes in mixed connective tissue disease: results from a multicentre cohort study

Author

Radin, M., primary, Schreiber, K., additional, Cuadrado, M., additional, Cecchi, I., additional, Laura, A., additional, Franceschini, F., additional, Caleiro, T., additional, Gibbone, E., additional, Khamashta, M., additional, Buyon, J., additional, Izmirly, P., additional, Aguirre Zamorano, M., additional, Roccatello, D., additional, Marozio, L., additional, and Sciascia, S., additional

Published
2018
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39. SAT0448 Report of 86 cases of congenital heart block: data from the italian registry (LU.NE REGISTRY)

Author

Fredi, M., primary, Andreoli, L., additional, Bertero, T., additional, Bortoluzzi, A., additional, Breda, S., additional, Cappa, V., additional, Ceccarelli, F., additional, Cimaz, R., additional, Franceschini, F., additional, Gerosa, M., additional, Govoni, M., additional, Hoxha, A., additional, Lojacono, A., additional, Marozio, L., additional, Mathieu, A., additional, Minniti, A., additional, Muscarà, M., additional, Padovan, M., additional, Piga, M., additional, Priori, R., additional, Ramoni, V., additional, Ruffatti, A., additional, Tonello, M., additional, Zatti, S., additional, Calza, S., additional, Brucato, A., additional, and Tincani, A., additional

Published
2018
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40. Heparin in pregnant women with previous placenta-mediated pregnancy complications: a prospective, randomized, multicenter, controlled clinical trial

Author

Martinelli, I, Ruggenenti, P, Cetin, I, Pardi, G, Perna, A, Acaia, B, Facchinetti, F, La Sala, GB, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, PM, VERGANI, PATRIZIA, LOCATELLI, ANNA, ORNAGHI, SARA, Martinelli, I, Ruggenenti, P, Cetin, I, Pardi, G, Perna, A, Vergani, P, Acaia, B, Facchinetti, F, La Sala, G, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, P, Locatelli, A, and Ornaghi, S

Subjects
Adult, medicine.medical_specialty, medicine.drug_class, Clinical Trials and Observations, Placenta, MED/40 - GINECOLOGIA E OSTETRICIA, Immunology, Low molecular weight heparin, heparin, Biochemistry, law.invention, Young Adult, Randomized controlled trial, law, Pregnancy, Internal medicine, Clinical endpoint, Medicine, Humans, Intention-to-treat analysis, Placental abruption, business.industry, Anticoagulants, preeclampsia, hemolytic anemia, elevated liver enzymes, low platelet count syndrome, intrauterine fetal death, fetal growth restriction, Cell Biology, Hematology, Heparin, Low-Molecular-Weight, Middle Aged, Interim analysis, medicine.disease, Surgery, Pregnancy Complications, Treatment Outcome, pregnancy, Nadroparin, Female, business
Abstract

To assess whether antithrombotic prophylaxis with low-molecular-weight heparin effectively prevents recurrence of late pregnancy complications, 135 women with previous history of preeclampsia, hemolytic anemia, elevated liver enzymes and low platelet count syndrome, intrauterine fetal death, fetal growth restriction, or placental abruption who had been referred within the 12th gestational week were randomized to medical surveillance alone (n = 68) or combined to open-label nadroparin (3800 IU daily subcutaneous injections) treatment (n = 67) in the setting of a randomized, parallel-group, superiority trial, run in Italy from April 2007 to April 2010. Primary outcome was a composite end point of late-pregnancy complications. Analysis was by intention to treat. The study was stopped for futility at the time of the first planned interim analysis. Among the 128 women eventually available for final analyses, 13 of the 63 (21%) randomized to nadroparin compared with 12 of the 65 (18%) on medical surveillance alone progressed to the primary end point. The absolute event risk difference between treatment arms (2.2; −1.6 to 16.0) was not statistically significant (P = .76). Thus, nadroparin did not prevent late-pregnancy complications in women at risk of recurrence. This finding challenges the role of antithrombotic prophylaxis with low-molecular-weight heparin in the prevention of recurrent late pregnancy complications The trial was registered at http://ricerca-clinica.agenziafarmaco.it as EudraCT 2006-004205-26.

Published
2012

44. Meta-analysis of low-molecular-weight heparin to prevent recurrent placenta-mediated pregnancy complications

Author

Rodger, M, Carrier, M, Le Gal, G, Martinelli, I, Perna, A, Rey, E, de Vries, J, Gris, J, Chauleur, C, Molinari, N, Mares, P, Fabbro Peray, P, Quere, I, Lefrant, J, Haddad, B, Dauzat, M, van Pampus, M, Hague, W, Bezemerand, P, Joosten, J, Ruggenenti, P, Cetin, I, Pardi, G, Vergani, P, Acaia, B, Facchinetti, F, Sala, G, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, P, Garneau, P, David, M, Gauthier, R, Leduc, L, Michon, N, Morin, F, Demers, C, Kahn, S, Magee, L, Rodger, MA, de Vries, JI, Gris, JC, Lefrant, JY, van Pampus, MG, Hague, WM, Bezemerand, PD, Joosten, JH, Mannucci, PM, Kahn, SR, Magee, LA, VERGANI, PATRIZIA, Rodger, M, Carrier, M, Le Gal, G, Martinelli, I, Perna, A, Rey, E, de Vries, J, Gris, J, Chauleur, C, Molinari, N, Mares, P, Fabbro Peray, P, Quere, I, Lefrant, J, Haddad, B, Dauzat, M, van Pampus, M, Hague, W, Bezemerand, P, Joosten, J, Ruggenenti, P, Cetin, I, Pardi, G, Vergani, P, Acaia, B, Facchinetti, F, Sala, G, Bozzo, M, Rampello, S, Marozio, L, Diadei, O, Gherardi, G, Carminati, S, Remuzzi, G, Mannucci, P, Garneau, P, David, M, Gauthier, R, Leduc, L, Michon, N, Morin, F, Demers, C, Kahn, S, Magee, L, Rodger, MA, de Vries, JI, Gris, JC, Lefrant, JY, van Pampus, MG, Hague, WM, Bezemerand, PD, Joosten, JH, Mannucci, PM, Kahn, SR, Magee, LA, and VERGANI, PATRIZIA

Abstract

A 35-year-old woman with recurrent severe placenta-mediated pregnancy complications in her 2 pregnancies asks: Will low-molecular-weight heparin help prevent recurrent placenta-mediated pregnancy complications in my next pregnancy? We performed a meta-analysis of randomized controlled trials (RCTs) comparing low-molecular-weight heparin (LMWH) vs no LMWH for the prevention of recurrent placenta-mediated pregnancy complications. We identified six RCTs that included a total of 848 pregnant women with prior placenta-mediated pregnancy complications. The primary outcome was a composite of pre-eclampsia (PE), birth of a small-for-gestational-age (SGA) newborn (<10th percentile), placental abruption, or pregnancy loss >20 weeks. Overall, 67 (18.7%) of 358 of women being given prophylactic LMWH had recurrent severe placenta-mediated pregnancy complications compared with 127 (42.9%) of 296 women with no LMWH (relative risk reduction, 0.52; 95% CI, 0.32 to 0.86; P = .01; I-2, 69%, indicating moderate heterogeneity). We identified similar relative risk reductions with LMWH for individual outcomes, including any PE, severe PE, SGA <10th percentile, SGA <5th percentile, preterm delivery <37 weeks, and preterm delivery <34 weeks with minimal heterogeneity. LMWH may be a promising therapy for recurrent, especially severe, placenta-mediated pregnancy complications, but further research is required

Published
2014

47. L5. Genetic aspects of preeclampsia

Author

Marozio, L., primary, Gibbone, E., additional, Tancredi, A., additional, Gaetano, C. Di, additional, Biasoni, V., additional, Polarolo, G., additional, and Benedetto, C., additional

Published
2011
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