دورية أكاديمية
Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE)
| العنوان: | Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE) |
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| المؤلفون: | Groussolles, Marion, Winer, Norbert, Sentilhes, Loïc, Biquart, Florence, Massoud, Mona, Vivanti, Alexandre, Bouchghoul, Hanane, Rozenberg, Patrick, Olivier, Pascale, Desbriere, Raoul, Chauleur, Celine, Perrotin, Franck, Coatleven, Frederic, Fuchs, Florent, Bretelle, Florence, Tsatsaris, Vassilis, Salomon, Laurent, Sananes, Nicolas, Kayem, Gilles, Houflin-Debarge, Veronique, Schmitz, Thomas, Benoist, Guillaume, Arnaud, Catherine, Ehlinger, Virginie, Vayssière, Christophe |
| المساهمون: | Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hôpital Femme Mère Enfant CHU - HCL (HFME), Hospices Civils de Lyon (HCL), AP-HP - Hôpital Antoine Béclère Clamart, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris-Sud - Paris 11 (UP11), Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre, Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS Poissy, Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Saint-Joseph Marseille, Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Bordeaux, CHU Montpellier, Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier), Hôpital Nord CHU - APHM, Maternité Port-Royal CHU Cochin, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin AP-HP, Hôpital Necker - Enfants Malades AP-HP, Université Paris Descartes - Paris 5 (UPD5), Centre Hospitalier Universitaire Strasbourg (CHU Strasbourg), Les Hôpitaux Universitaires de Strasbourg (HUS), CHU Trousseau APHP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Jeanne de Flandres, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille), Hôpital Robert Debré, Université Paris Diderot - Paris 7 (UPD7), Service de Gynécologie-Obstétrique et Médecine de la Reproduction CHU Caen, Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Equipe SPHERE (CERPOP), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), The French Ministry of Health (Programme Hospitalier de Recherche Clinique, AOM2013) supported this study,which was sponsored by the Department of Clinical Research of the Toulouse University Hospital Center, France |
| المصدر: | ISSN: 0002-9378. |
| بيانات النشر: | HAL CCSD Elsevier |
| سنة النشر: | 2022 |
| المجموعة: | Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQ |
| مصطلحات موضوعية: | adverse neonatal outcomes, pessary, preterm birth, short cervix, twin pregnancies, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics |
| الوصف: | International audience ; Background: The number of twin pregnancies continues to increase worldwide as both the number of pregnancies obtained by medically assisted reproduction and age at first pregnancy keep rising. Preterm delivery is the major complication associated with twin pregnancies. The effectiveness of preventive treatments such as progesterone or cervical cerclage for women with a short cervix is doubtful in twin pregnancies. The effectivity of cervical pessaries in preventing preterm birth and its associated morbidity and mortality is also controversial.Objective: We sought to investigate if the Arabin pessary reduces adverse neonatal outcomes in twin pregnancies with a short cervix.Study design: This open-label, multicenter, randomized controlled trial on twin pregnancies with a cervical length of <35 mm compared pessary placement at 16+0 to 24+0 weeks' gestation with standard care alone. The primary endpoint was a composite of adverse neonatal outcomes, namely peripartum or neonatal death or significant neonatal morbidity before hospital discharge, defined as at least 1 of the following complications: bronchopulmonary dysplasia, intraventricular hemorrhage grade III to IV, periventricular leukomalacia, necrotizing enterocolitis grade II or higher, culture-proven sepsis, and retinopathy requiring treatment. A sample size of 308 pregnancies was planned to ensure 80% power to compare the proportions of women with at least 1 infant with an adverse neonatal outcome. The intention-to-treat analysis after multiple imputation of missing data, was supplemented with a secondary analysis that controlled for gestational age and cervical length, both at inclusion. The primary endpoint was also compared between randomization groups in the per-protocol population, which excluded patients with prespecified major protocol violations (mostly cervical cerclage and/or progesterone after inclusion). Secondary endpoints included preterm birth, spontaneous preterm birth, and pessary side effects.Results: In total, ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/35123930; inserm-03617419; https://inserm.hal.science/inserm-03617419Test; https://inserm.hal.science/inserm-03617419/documentTest; https://inserm.hal.science/inserm-03617419/file/1-s2.0-S0002937822000989-main.pdfTest; PUBMED: 35123930 |
| DOI: | 10.1016/j.ajog.2022.01.038 |
| الإتاحة: | https://doi.org/10.1016/j.ajog.2022.01.038Test https://inserm.hal.science/inserm-03617419Test https://inserm.hal.science/inserm-03617419/documentTest https://inserm.hal.science/inserm-03617419/file/1-s2.0-S0002937822000989-main.pdfTest |
| حقوق: | http://hal.archives-ouvertes.fr/licences/copyrightTest/ |
| رقم الانضمام: | edsbas.D25A3557 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.ajog.2022.01.038 |
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