دورية أكاديمية
Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)
| العنوان: | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
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| المؤلفون: | Devillard, Eric, Petillon, Fanny, Rouzaire, Marion, Pereira, Bruno, Accoceberry, Marie, Houlle, Céline, Dejou-Bouillet, Lydie, Bouchet, Pamela, Delabaere, Amélie, Gallot, Denis |
| المساهمون: | Service de Gynécologie CHU Clermont-Ferrand, CHU Estaing Clermont-Ferrand, CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service Obstétrique CHU Clermont-Ferrand, Centre Hospitalier de Vienne Lucien Hussel (CH Vienne), Unité de Biostatistiques CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation CHU Clermont-Ferrand (DRCI), Génétique, Reproduction et Développement (GReD), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne (UCA) |
| المصدر: | ISSN: 2077-0383 ; Journal of Clinical Medicine ; https://hal.science/hal-03824651Test ; Journal of Clinical Medicine, 2022, 11 (6), pp.1525. ⟨10.3390/jcm11061525⟩. |
| بيانات النشر: | HAL CCSD MDPI |
| سنة النشر: | 2022 |
| المجموعة: | HAL Clermont Auvergne (Université Blaise Pascal Clermont-Ferrand / Université d'Auvergne) |
| مصطلحات موضوعية: | cervical ripening balloon, labor induction, nulliparous, premature rupture of membranes, unfavorable cervix, [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics |
| الوصف: | International audience ; Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/35329852; hal-03824651; https://hal.science/hal-03824651Test; https://hal.science/hal-03824651/documentTest; https://hal.science/hal-03824651/file/jcm-11-01525.pdfTest; PUBMED: 35329852; PUBMEDCENTRAL: PMC8952372 |
| DOI: | 10.3390/jcm11061525 |
| الإتاحة: | https://doi.org/10.3390/jcm11061525Test https://hal.science/hal-03824651Test https://hal.science/hal-03824651/documentTest https://hal.science/hal-03824651/file/jcm-11-01525.pdfTest |
| حقوق: | http://creativecommons.org/licenses/byTest/ ; info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.B1DF7BB1 |
| قاعدة البيانات: | BASE |
| DOI: | 10.3390/jcm11061525 |
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