Caroline Diguisto1,2,3, Amélie Le Gouge4, Chloé Arthuis5, Norbert Winer5, Olivier Parant6, Christophe Poncelet7,8, Celine Chauleur9,10, Jacob Hannigsberg11, Guillaume Ducarme12, Denis Gallot13, Rene Gabriel14, Raoul Desbriere15, Gael Beucher16, Cyrille Faraguet17, Helene Isly18, Patrick Rozenberg19,20, Bruno Giraudeau2,4, Franck Perrotin1,2,21. 1. Pôle de gynécologie obstétrique, médecine fœtale, médecine et biologie de la reproduction, centre Olympe de Gouges, CHRU de Tours, Tours, France. 2. Université de Tours, France. 3. Université de Paris, CRESS, INSERM, INRA, Paris, France. 4. INSERM CIC1415, CHRU de Tours, Tours, France. 5. Department of Obstetrics and Gynecology, University Hospital of Nantes, NUN, INRAE, UMR 1280, PhAN, Université de Nantes, France. 6. Pôle de gynécologie obstétrique, hôpital Paule-de-Viguier, CHU de Toulouse, Toulouse, France. 7. Department of Obstetrics and Gynecology, Rene DUBOS Hospital, Cergy-Pontoise, France. 8. Université Paris 13, Sorbonne Paris Cité, UFR SMBH, Bobigny, France. 9. Department of Gynecology and Obstetrics, University Hospital of Saint-Etienne, Saint-Etienne, France. 10. INSERM, SAINBIOSE, U1059, Dysfonction Vasculaire et Hémostase, Université Jean-Monnet; CIC1408, Saint-Etienne, France. 11. CHU Brest, Hôpital Morvan, service de gynécologie-obstétrique, Brest, France. 12. Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, La Roche sur Yon, France. 13. Pôle femme et enfant, CHU Estaing, 1, place Lucie-et-Raymond-Aubrac, Clermont-Ferrand, France, Team Translational approach to epithelial injury and repair, UMR6293 CNRS-Université Clermont Auvergne, U1103 Inserm, GReD, Clermont-Ferrand, France. 14. Service de Gynécologie-Obstétrique, Hôpital Maison Blanche, Reims Cedex, Université de Reims Champagne Ardennes, France. 15. Hôpital Saint Joseph, Department of Obstetrics and Gynecology, Marseille, France. 16. Service de gynécologie obstétrique et médecine de la reproduction, CHU de Caen, Caen, France. 17. Service de Gynécologie Obstétrique, Centre Hospitalier de Chartre, France. 18. Service de Gynécologie Obstétrique, Centre Hospitalier Universitaire de Rennes, France. 19. Department of Obstetrics and Gynecology, Poissy-Saint Germain Hospital, Poissy, France. 20. Versailles St-Quentin University, research unit EA 7285. Montigny-le-Bretonneux, France. 21. INSERM U1253 Imaging and Brain (iBrain), Tours, France.
Abstract
BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.
RCT Entities:
BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.
Authors: Victor M Montori; Gaietà Permanyer-Miralda; Ignacio Ferreira-González; Jason W Busse; Valeria Pacheco-Huergo; Dianne Bryant; Jordi Alonso; Elie A Akl; Antònia Domingo-Salvany; Edward Mills; Ping Wu; Holger J Schünemann; Roman Jaeschke; Gordon H Guyatt Journal: BMJ Date: 2005-03-12
Authors: Yvonne W Cheng; James M Nicholson; Sanae Nakagawa; Tim A Bruckner; A Eugene Washington; Aaron B Caughey Journal: Am J Obstet Gynecol Date: 2008-10 Impact factor: 8.661
Authors: Joep C Kortekaas; Anke C Scheuer; Esteriek de Miranda; Aimée E van Dijk; Judit K J Keulen; Aafke Bruinsma; Ben W J Mol; Frank P H A Vandenbussche; Jeroen van Dillen Journal: BMC Pregnancy Childbirth Date: 2018-09-20 Impact factor: 3.007