Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial
Introduction The aim of this study was to compare the efficacy and maternal‐neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix. Material and methods This open‐label randomized controlled trial took place...
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| Veröffentlicht in: | Acta obstetricia et gynecologica Scandinavica 2020-02, Vol.99 (2), p.259-266 |
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| container_title | Acta obstetricia et gynecologica Scandinavica |
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| creator | Sarreau, Mélie Isly, Helene Poulain, Patrice Fontaine, Brigitte Morel, Olivier Villemonteix, Pascal Mares, Pierre Mousty, Eve Godard, Alain Ragot, Stephanie Pierre, Fabrice |
| description | Introduction
The aim of this study was to compare the efficacy and maternal‐neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix.
Material and methods
This open‐label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre‐labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50‐mL balloon catheter for 12 hours or a low‐dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications.
Results
The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score.
Conclusions
Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low‐dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction. |
| doi_str_mv | 10.1111/aogs.13712 |
| format | Article |
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The aim of this study was to compare the efficacy and maternal‐neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix.
Material and methods
This open‐label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre‐labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50‐mL balloon catheter for 12 hours or a low‐dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications.
Results
The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score.
Conclusions
Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low‐dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.</description><identifier>ISSN: 0001-6349</identifier><identifier>EISSN: 1600-0412</identifier><identifier>DOI: 10.1111/aogs.13712</identifier><identifier>PMID: 31432510</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>Adult ; balloon catheter ; Bioengineering ; Catheterization - methods ; Catheters ; Cervical Ripening - drug effects ; Cesarean section ; Childbirth & labor ; Clinical trials ; Computer Science ; Female ; France ; Health risk assessment ; Human health and pathology ; Humans ; Induced labor ; induction of labor ; Labor, Induced - methods ; Life Sciences ; Medical Imaging ; Nuclear medicine ; Oxytocics - administration & dosage ; oxytocin ; Oxytocin - administration & dosage ; Pregnancy ; Prospective Studies ; Vaginal Birth after Cesarean ; vaginal delivery ; Womens health</subject><ispartof>Acta obstetricia et gynecologica Scandinavica, 2020-02, Vol.99 (2), p.259-266</ispartof><rights>2019 Nordic Federation of Societies of Obstetrics and Gynecology</rights><rights>2019 Nordic Federation of Societies of Obstetrics and Gynecology.</rights><rights>Copyright © 2020 Acta Obstetricia et Gynecologica Scandinavica</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4272-56216cad9c095abda3ac28e9aec0be63a4273caadf01d80d2e6e489b63bc03163</citedby><cites>FETCH-LOGICAL-c4272-56216cad9c095abda3ac28e9aec0be63a4273caadf01d80d2e6e489b63bc03163</cites><orcidid>0000-0003-4852-1465</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Faogs.13712$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Faogs.13712$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,780,784,885,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31432510$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-lorraine.fr/hal-03258698$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Sarreau, Mélie</creatorcontrib><creatorcontrib>Isly, Helene</creatorcontrib><creatorcontrib>Poulain, Patrice</creatorcontrib><creatorcontrib>Fontaine, Brigitte</creatorcontrib><creatorcontrib>Morel, Olivier</creatorcontrib><creatorcontrib>Villemonteix, Pascal</creatorcontrib><creatorcontrib>Mares, Pierre</creatorcontrib><creatorcontrib>Mousty, Eve</creatorcontrib><creatorcontrib>Godard, Alain</creatorcontrib><creatorcontrib>Ragot, Stephanie</creatorcontrib><creatorcontrib>Pierre, Fabrice</creatorcontrib><title>Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial</title><title>Acta obstetricia et gynecologica Scandinavica</title><addtitle>Acta Obstet Gynecol Scand</addtitle><description>Introduction
The aim of this study was to compare the efficacy and maternal‐neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix.
Material and methods
This open‐label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre‐labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50‐mL balloon catheter for 12 hours or a low‐dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications.
Results
The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score.
Conclusions
Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low‐dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.</description><subject>Adult</subject><subject>balloon catheter</subject><subject>Bioengineering</subject><subject>Catheterization - methods</subject><subject>Catheters</subject><subject>Cervical Ripening - drug effects</subject><subject>Cesarean section</subject><subject>Childbirth & labor</subject><subject>Clinical trials</subject><subject>Computer Science</subject><subject>Female</subject><subject>France</subject><subject>Health risk assessment</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Induced labor</subject><subject>induction of labor</subject><subject>Labor, Induced - methods</subject><subject>Life Sciences</subject><subject>Medical Imaging</subject><subject>Nuclear medicine</subject><subject>Oxytocics - administration & dosage</subject><subject>oxytocin</subject><subject>Oxytocin - administration & dosage</subject><subject>Pregnancy</subject><subject>Prospective Studies</subject><subject>Vaginal Birth after Cesarean</subject><subject>vaginal delivery</subject><subject>Womens health</subject><issn>0001-6349</issn><issn>1600-0412</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90Utv1DAQAGALgei2cOEHIEtcaKUUv9ab9LZU0CKt1ANwtibOhHXlxIudbFmO_eX1btoeOOCDH6PPI4-HkHecnfM8PkH4lc65XHDxgsy4ZqxgiouXZMYY44WWqjoixynd5pNYqPI1OZJcSTHnbEbuP4P3IfTUwrDGASPdJhr-7IZgXU_Bhx5pGyJ1fTPawWUYWuqhPoToXegwz25YU6CbiFsXxkQtJogIPU14uHJBlzRC34TO_cWG2tAPMXift0N04N-QVy34hG8f1xPy8-uXH5fXxerm6tvlclVYJRaimGvBtYWmsqyaQ92ABCtKrAAtq1FLyEpagKZlvClZI1CjKqtay9oyybU8IadT3jV4s4mug7gzAZy5Xq7MPsbyn5S6Krc824-T3cTwe8Q0mM4li95Dj7lEI0SGqpSVyvTDP_Q2jLHPlRghFeMLUVbzrM4mZWNIKWL7_ALOzL6LZt9Fc-hixu8fU451h80zfWpbBnwCd87j7j-pzPLm6vuU9AHf46g-</recordid><startdate>202002</startdate><enddate>202002</enddate><creator>Sarreau, Mélie</creator><creator>Isly, Helene</creator><creator>Poulain, Patrice</creator><creator>Fontaine, Brigitte</creator><creator>Morel, Olivier</creator><creator>Villemonteix, Pascal</creator><creator>Mares, Pierre</creator><creator>Mousty, Eve</creator><creator>Godard, Alain</creator><creator>Ragot, Stephanie</creator><creator>Pierre, Fabrice</creator><general>John Wiley & Sons, Inc</general><general>Wiley</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0003-4852-1465</orcidid></search><sort><creationdate>202002</creationdate><title>Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial</title><author>Sarreau, Mélie ; Isly, Helene ; Poulain, Patrice ; Fontaine, Brigitte ; Morel, Olivier ; Villemonteix, Pascal ; Mares, Pierre ; Mousty, Eve ; Godard, Alain ; Ragot, Stephanie ; Pierre, Fabrice</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4272-56216cad9c095abda3ac28e9aec0be63a4273caadf01d80d2e6e489b63bc03163</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>balloon catheter</topic><topic>Bioengineering</topic><topic>Catheterization - methods</topic><topic>Catheters</topic><topic>Cervical Ripening - drug effects</topic><topic>Cesarean section</topic><topic>Childbirth & labor</topic><topic>Clinical trials</topic><topic>Computer Science</topic><topic>Female</topic><topic>France</topic><topic>Health risk assessment</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Induced labor</topic><topic>induction of labor</topic><topic>Labor, Induced - methods</topic><topic>Life Sciences</topic><topic>Medical Imaging</topic><topic>Nuclear medicine</topic><topic>Oxytocics - administration & dosage</topic><topic>oxytocin</topic><topic>Oxytocin - administration & dosage</topic><topic>Pregnancy</topic><topic>Prospective Studies</topic><topic>Vaginal Birth after Cesarean</topic><topic>vaginal delivery</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sarreau, Mélie</creatorcontrib><creatorcontrib>Isly, Helene</creatorcontrib><creatorcontrib>Poulain, Patrice</creatorcontrib><creatorcontrib>Fontaine, Brigitte</creatorcontrib><creatorcontrib>Morel, Olivier</creatorcontrib><creatorcontrib>Villemonteix, Pascal</creatorcontrib><creatorcontrib>Mares, Pierre</creatorcontrib><creatorcontrib>Mousty, Eve</creatorcontrib><creatorcontrib>Godard, Alain</creatorcontrib><creatorcontrib>Ragot, Stephanie</creatorcontrib><creatorcontrib>Pierre, Fabrice</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Acta obstetricia et gynecologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sarreau, Mélie</au><au>Isly, Helene</au><au>Poulain, Patrice</au><au>Fontaine, Brigitte</au><au>Morel, Olivier</au><au>Villemonteix, Pascal</au><au>Mares, Pierre</au><au>Mousty, Eve</au><au>Godard, Alain</au><au>Ragot, Stephanie</au><au>Pierre, Fabrice</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial</atitle><jtitle>Acta obstetricia et gynecologica Scandinavica</jtitle><addtitle>Acta Obstet Gynecol Scand</addtitle><date>2020-02</date><risdate>2020</risdate><volume>99</volume><issue>2</issue><spage>259</spage><epage>266</epage><pages>259-266</pages><issn>0001-6349</issn><eissn>1600-0412</eissn><abstract>Introduction
The aim of this study was to compare the efficacy and maternal‐neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix.
Material and methods
This open‐label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre‐labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50‐mL balloon catheter for 12 hours or a low‐dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications.
Results
The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score.
Conclusions
Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low‐dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>31432510</pmid><doi>10.1111/aogs.13712</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-4852-1465</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Acta obstetricia et gynecologica Scandinavica, 2020-02, Vol.99 (2), p.259-266 |
| issn | 0001-6349 1600-0412 |
| language | eng |
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| source | MEDLINE; Wiley Online Library All Journals |
| subjects | Adult balloon catheter Bioengineering Catheterization - methods Catheters Cervical Ripening - drug effects Cesarean section Childbirth & labor Clinical trials Computer Science Female France Health risk assessment Human health and pathology Humans Induced labor induction of labor Labor, Induced - methods Life Sciences Medical Imaging Nuclear medicine Oxytocics - administration & dosage oxytocin Oxytocin - administration & dosage Pregnancy Prospective Studies Vaginal Birth after Cesarean vaginal delivery Womens health |
| title | Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial |
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