دورية أكاديمية

Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments.

التفاصيل البيبلوغرافية
العنوان: Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments.
المؤلفون: Devillard, Eric, Delabaere, Amélie, Rouzaire, Marion, Pereira, Bruno, Accoceberry, Marie, Houlle, Céline, Dejou-Bouillet, Lydie, Bouchet, Pamela, Gallot, Denis
المساهمون: Service de Gynécologie CHU Clermont-Ferrand, CHU Estaing Clermont-Ferrand, CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service Obstétrique CHU Clermont-Ferrand, 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), Unité de Biostatistiques CHU Clermont-Ferrand, Direction de la recherche clinique et de l’innovation CHU Clermont-Ferrand (DRCI)
المصدر: ISSN: 2044-6055 ; BMJ Open ; https://uca.hal.science/hal-03023305Test ; BMJ Open, 2019, 9 (6), pp.e026090. ⟨10.1136/bmjopen-2018-026090⟩.
بيانات النشر: HAL CCSD
BMJ Publishing Group
سنة النشر: 2019
المجموعة: HAL Clermont Auvergne (Université Blaise Pascal Clermont-Ferrand / Université d'Auvergne)
مصطلحات موضوعية: cervical ripening balloon, labor induction, pharmacological cervical maturation, premature rupture of membranes, unfavorable cervix, MESH: Administration, Intravaginal, MESH: Catheters, MESH: Cervical Ripening, MESH: Cervix Uteri, MESH: Delayed-Action Preparations, MESH: Delivery, Obstetric, MESH: Female, MESH: Fetal Membranes, Premature Rupture, MESH: France, MESH: Humans, MESH: Labor, Induced, MESH: Oxytocics, MESH: Oxytocin, MESH: Parity, MESH: Pregnancy, MESH: Prospective Studies, MESH: Prostaglandins, MESH: Randomized Controlled Trials as Topic, [SDV.BDLR.RS]Life Sciences [q-bio]/Reproductive Biology/Sexual reproduction
الوصف: International audience ; Introduction: Premature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysis: We are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required.Ethics and dissemination: Written informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/31227530; hal-03023305; https://uca.hal.science/hal-03023305Test; https://uca.hal.science/hal-03023305/documentTest; https://uca.hal.science/hal-03023305/file/e026090.full.pdfTest; PUBMED: 31227530; PUBMEDCENTRAL: PMC6596956
DOI: 10.1136/bmjopen-2018-026090
الإتاحة: https://doi.org/10.1136/bmjopen-2018-026090Test
https://uca.hal.science/hal-03023305Test
https://uca.hal.science/hal-03023305/documentTest
https://uca.hal.science/hal-03023305/file/e026090.full.pdfTest
حقوق: http://creativecommons.org/licenses/byTest/ ; info:eu-repo/semantics/OpenAccess
رقم الانضمام: edsbas.87088722
قاعدة البيانات: BASE