Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial
| Autor: | Cedric Lavergne, Patrick Rozenberg, Emmanuel Roth, Emma Orusco, Sophie Javoise, Mathieu Morin, Adeline Gallini, Pascale Olivier, Virginie Ehlinger, Julie Fort, Groupe de Recherche en Obstétrique rt Gynécologie, Marie-Victoire Senat, Catherine Arnaud, Adrien Gaudineau, Christophe Vayssière |
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| Přispěvatelé: | CHU Strasbourg, Service de Gynécologie [Hôpital Princesse Grace, Monaco], Hôpital Princesse Grace [Monaco], Hôpital Bicêtre, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'épidémiologie [Toulouse], CHU Toulouse [Toulouse], Service de gynécologie et obstétrique [CHI Poissy-Saint Germain], CHI Poissy-Saint-Germain, Ministère des Affaires Sociales et de la Santé, Centre Hospitalier Universitaire de Toulouse, This study was supported by a grant from the French Ministry of Health under its Clinical Research Hospital Program (Programme Hospitalier de Recherche Clinique, June 18, 2010) and promoted by the Departement of Clinical Research of the Toulouse University Hospital Center., Hôpital Paule de Viguier |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Pessary induction of labor medicine.medical_specialty medicine.medical_treatment Bishop score [SDV.MHEP.GEO]Life Sciences [q-bio]/Human health and pathology/Gynecology and obstetrics law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Obstetrics and gynaecology Pregnancy law Oxytocics medicine vaginal Humans dinoprostone Labor Induced 030212 general & internal medicine Cervix Misoprostol misoprostol 030219 obstetrics & reproductive medicine Cesarean Section business.industry Vaginal delivery Obstetrics Obstetrics and Gynecology Pessaries Delivery Obstetric 3. Good health medicine.anatomical_structure Patient Satisfaction Labor induction term pregnancy Female prostaglandin E2 pessary business Cervical Ripening medicine.drug |
| Zdroj: | unknow unknow, 2021, unknow, France. pp.542.e1-542.e8, ⟨10.1016/j.ajog.2021.04.226⟩ |
| DOI: | 10.1016/j.ajog.2021.04.226⟩ |
| Popis: | International audience; Background: Induction of labor is among the most common procedures for pregnant women. Only a few randomized clinical trials with relatively small samples have compared misoprostol with dinoprostone. Although their efficacy seems similar, their safety profiles have not been adequately evaluated, and economic data are sparse. Objective: This study aimed to test the noninferiority of vaginal misoprostol (prostaglandin E1) (25 μg) to a slow-release dinoprostone (prostaglandin E2) pessary (10 μg) for induction of labor with an unfavorable cervix at term. Study Design: This was an open-label multicenter randomized noninferiority trial at 4 university hospitals of the Research Group in Obstetrics and Gynecology between 2012 and 2015. We recruited women who underwent induction of labor for medical reasons, those with a Bishop score of ≤5 at ≥36 weeks’ gestation, and those with a cephalic-presenting singleton pregnancy with no previous cesarean delivery. Women were randomly allocated to receive either vaginal misoprostol at 4-hour intervals (25 μg) or a 10-mg slow-release dinoprostone pessary. The primary outcome was the total cesarean delivery rate. Noninferiority was defined as a difference in the cesarean delivery rates between the groups of no more than 5%. Secondary outcomes included neonatal and maternal morbidity, vaginal delivery at |
| Databáze: | OpenAIRE |
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