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Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial

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 ripenin...

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Autores principales: Diguisto, Caroline, Le Gouge, Amélie, Arthuis, Chloé, Winer, Norbert, Parant, Olivier, Poncelet, Christophe, Chauleur, Celine, Hannigsberg, Jacob, Ducarme, Guillaume, Gallot, Denis, Gabriel, Rene, Desbriere, Raoul, Beucher, Gael, Faraguet, Cyrille, Isly, Helene, Rozenberg, Patrick, Giraudeau, Bruno, Perrotin, Franck
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877637/
https://www.ncbi.nlm.nih.gov/pubmed/33571294
http://dx.doi.org/10.1371/journal.pmed.1003448
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author Diguisto, Caroline
Le Gouge, Amélie
Arthuis, Chloé
Winer, Norbert
Parant, Olivier
Poncelet, Christophe
Chauleur, Celine
Hannigsberg, Jacob
Ducarme, Guillaume
Gallot, Denis
Gabriel, Rene
Desbriere, Raoul
Beucher, Gael
Faraguet, Cyrille
Isly, Helene
Rozenberg, Patrick
Giraudeau, Bruno
Perrotin, Franck
author_facet Diguisto, Caroline
Le Gouge, Amélie
Arthuis, Chloé
Winer, Norbert
Parant, Olivier
Poncelet, Christophe
Chauleur, Celine
Hannigsberg, Jacob
Ducarme, Guillaume
Gallot, Denis
Gabriel, Rene
Desbriere, Raoul
Beucher, Gael
Faraguet, Cyrille
Isly, Helene
Rozenberg, Patrick
Giraudeau, Bruno
Perrotin, Franck
author_sort Diguisto, Caroline
collection PubMed
description 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.
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spelling pubmed-78776372021-02-19 Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial Diguisto, Caroline Le Gouge, Amélie Arthuis, Chloé Winer, Norbert Parant, Olivier Poncelet, Christophe Chauleur, Celine Hannigsberg, Jacob Ducarme, Guillaume Gallot, Denis Gabriel, Rene Desbriere, Raoul Beucher, Gael Faraguet, Cyrille Isly, Helene Rozenberg, Patrick Giraudeau, Bruno Perrotin, Franck PLoS Med Research Article 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. Public Library of Science 2021-02-11 /pmc/articles/PMC7877637/ /pubmed/33571294 http://dx.doi.org/10.1371/journal.pmed.1003448 Text en © 2021 Diguisto et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Diguisto, Caroline
Le Gouge, Amélie
Arthuis, Chloé
Winer, Norbert
Parant, Olivier
Poncelet, Christophe
Chauleur, Celine
Hannigsberg, Jacob
Ducarme, Guillaume
Gallot, Denis
Gabriel, Rene
Desbriere, Raoul
Beucher, Gael
Faraguet, Cyrille
Isly, Helene
Rozenberg, Patrick
Giraudeau, Bruno
Perrotin, Franck
Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title_full Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title_fullStr Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title_full_unstemmed Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title_short Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial
title_sort cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: the magpop randomised controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877637/
https://www.ncbi.nlm.nih.gov/pubmed/33571294
http://dx.doi.org/10.1371/journal.pmed.1003448
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