Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)
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, rand...
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| Format: | Article |
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MDPI AG
2022-03-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/11/6/1525 |
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| author | Eric Devillard Fanny Petillon Marion Rouzaire Bruno Pereira Marie Accoceberry Céline Houlle Lydie Dejou-Bouillet Pamela Bouchet Amélie Delabaere Denis Gallot |
| author_facet | Eric Devillard Fanny Petillon Marion Rouzaire Bruno Pereira Marie Accoceberry Céline Houlle Lydie Dejou-Bouillet Pamela Bouchet Amélie Delabaere Denis Gallot |
| author_sort | Eric Devillard |
| collection | DOAJ |
| description | 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), <i>p</i> = 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), <i>p</i> = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, <i>p</i> = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, <i>p</i> > 0.05), chorioamnionitis (0% versus 2.5%, <i>p</i> = 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. |
| first_indexed | 2024-03-09T19:38:19Z |
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| id | doaj.art-a5d1dce50c90410f9e7954d83a1aee98 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-09T19:38:19Z |
| publishDate | 2022-03-01 |
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| series | Journal of Clinical Medicine |
| spelling | doaj.art-a5d1dce50c90410f9e7954d83a1aee982023-11-24T01:47:33ZengMDPI AGJournal of Clinical Medicine2077-03832022-03-01116152510.3390/jcm11061525Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)Eric Devillard0Fanny Petillon1Marion Rouzaire2Bruno Pereira3Marie Accoceberry4Céline Houlle5Lydie Dejou-Bouillet6Pamela Bouchet7Amélie Delabaere8Denis Gallot9Department of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceBiostatistics Unit (DRCI), CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, FranceBackground: 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), <i>p</i> = 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), <i>p</i> = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, <i>p</i> = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, <i>p</i> > 0.05), chorioamnionitis (0% versus 2.5%, <i>p</i> = 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.https://www.mdpi.com/2077-0383/11/6/1525premature rupture of membraneslabor inductionunfavorable cervixcervical ripening balloonnulliparous |
| spellingShingle | Eric Devillard Fanny Petillon Marion Rouzaire Bruno Pereira Marie Accoceberry Céline Houlle Lydie Dejou-Bouillet Pamela Bouchet Amélie Delabaere Denis Gallot Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) Journal of Clinical Medicine premature rupture of membranes labor induction unfavorable cervix cervical ripening balloon nulliparous |
| title | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
| title_full | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
| title_fullStr | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
| title_full_unstemmed | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
| title_short | Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO) |
| title_sort | double balloon catheter plus oxytocin versus dinoprostone vaginal insert for term rupture of membranes a randomized controlled trial rubapro |
| topic | premature rupture of membranes labor induction unfavorable cervix cervical ripening balloon nulliparous |
| url | https://www.mdpi.com/2077-0383/11/6/1525 |
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