Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial
OBJECTIVE:To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. METHODS:This is a randomized, multicenter trial of wome...
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Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2018-01, Vol.131 (1), p.4-11 |
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creator | Mackeen, A Dhanya Durie, Danielle E Lin, Monique Huls, Christopher K Qureshey, Emma Paglia, Michael J Sun, Haiyan Sciscione, Anthony |
description | OBJECTIVE:To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes.
METHODS:This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat.
RESULTS:We enrolled 201 women93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groupsin the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P |
doi_str_mv | 10.1097/AOG.0000000000002374 |
format | Article |
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METHODS:This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat.
RESULTS:We enrolled 201 women93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groupsin the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied.
CONCLUSION:In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT01973036.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/AOG.0000000000002374</identifier><identifier>PMID: 29215519</identifier><language>eng</language><publisher>United States: by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</publisher><subject>Adult ; Cervical Ripening - drug effects ; Combined Modality Therapy ; Female ; Fetal Membranes, Premature Rupture - drug therapy ; Gestational Age ; Humans ; Infant, Newborn ; Infusions, Intravenous ; Labor, Induced - methods ; Oxytocin - administration & dosage ; Pregnancy ; Pregnancy Outcome ; Risk Assessment ; Urinary Catheterization - methods ; Young Adult</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2018-01, Vol.131 (1), p.4-11</ispartof><rights>2018 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3054-aedf21b00cecbe7321fb2bcbd02768f022f351d66066ec19b8eadac9695aaca83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29215519$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mackeen, A Dhanya</creatorcontrib><creatorcontrib>Durie, Danielle E</creatorcontrib><creatorcontrib>Lin, Monique</creatorcontrib><creatorcontrib>Huls, Christopher K</creatorcontrib><creatorcontrib>Qureshey, Emma</creatorcontrib><creatorcontrib>Paglia, Michael J</creatorcontrib><creatorcontrib>Sun, Haiyan</creatorcontrib><creatorcontrib>Sciscione, Anthony</creatorcontrib><title>Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>OBJECTIVE:To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes.
METHODS:This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat.
RESULTS:We enrolled 201 women93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groupsin the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied.
CONCLUSION:In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT01973036.</description><subject>Adult</subject><subject>Cervical Ripening - drug effects</subject><subject>Combined Modality Therapy</subject><subject>Female</subject><subject>Fetal Membranes, Premature Rupture - drug therapy</subject><subject>Gestational Age</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infusions, Intravenous</subject><subject>Labor, Induced - methods</subject><subject>Oxytocin - administration & dosage</subject><subject>Pregnancy</subject><subject>Pregnancy Outcome</subject><subject>Risk Assessment</subject><subject>Urinary Catheterization - methods</subject><subject>Young Adult</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEtLxDAQx4Mouq5-A5EcvXTNo694K8XHwsqKKHoraTplq2mzJi3r-umNrC88mMuE4Tf_GX4IHVEyoUQkp9n8ckJ-PcaTcAuNaJrwgHH-uI1GvimCJA3DPbTv3JOHaCz4LtpjgtEoomKEugujYY1v9ODw_HXdG9V0ODftUlqo8EPTL37atbF42lWD6hvT4azuweJraEsrO8C3w7IfLJzhDN_KrjJt8-YDctP11mjtv3e2kfoA7dRSOzj8rGN0f3F-l18Fs_nlNM9mgeIkCgMJVc1oSYgCVULCGa1LVqqyIiyJ05owVvOIVnFM4hgUFWUKspJKxCKSUsmUj9HJJndpzcsAri_axinQ2p9qBldQkYSECBp-oOEGVdY4Z6EulrZppV0XlBQfpgtvuvhr2o8df24Yyhaq76EvtR5IN8DKaG_KPethBbZYgNT94v_sdwhBi8I</recordid><startdate>201801</startdate><enddate>201801</enddate><creator>Mackeen, A Dhanya</creator><creator>Durie, Danielle E</creator><creator>Lin, Monique</creator><creator>Huls, Christopher K</creator><creator>Qureshey, Emma</creator><creator>Paglia, Michael J</creator><creator>Sun, Haiyan</creator><creator>Sciscione, Anthony</creator><general>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</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>7X8</scope></search><sort><creationdate>201801</creationdate><title>Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial</title><author>Mackeen, A Dhanya ; Durie, Danielle E ; Lin, Monique ; Huls, Christopher K ; Qureshey, Emma ; Paglia, Michael J ; Sun, Haiyan ; Sciscione, Anthony</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3054-aedf21b00cecbe7321fb2bcbd02768f022f351d66066ec19b8eadac9695aaca83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Cervical Ripening - drug effects</topic><topic>Combined Modality Therapy</topic><topic>Female</topic><topic>Fetal Membranes, Premature Rupture - drug therapy</topic><topic>Gestational Age</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infusions, Intravenous</topic><topic>Labor, Induced - methods</topic><topic>Oxytocin - administration & dosage</topic><topic>Pregnancy</topic><topic>Pregnancy Outcome</topic><topic>Risk Assessment</topic><topic>Urinary Catheterization - methods</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mackeen, A Dhanya</creatorcontrib><creatorcontrib>Durie, Danielle E</creatorcontrib><creatorcontrib>Lin, Monique</creatorcontrib><creatorcontrib>Huls, Christopher K</creatorcontrib><creatorcontrib>Qureshey, Emma</creatorcontrib><creatorcontrib>Paglia, Michael J</creatorcontrib><creatorcontrib>Sun, Haiyan</creatorcontrib><creatorcontrib>Sciscione, Anthony</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mackeen, A Dhanya</au><au>Durie, Danielle E</au><au>Lin, Monique</au><au>Huls, Christopher K</au><au>Qureshey, Emma</au><au>Paglia, Michael J</au><au>Sun, Haiyan</au><au>Sciscione, Anthony</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2018-01</date><risdate>2018</risdate><volume>131</volume><issue>1</issue><spage>4</spage><epage>11</epage><pages>4-11</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><abstract>OBJECTIVE:To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes.
METHODS:This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat.
RESULTS:We enrolled 201 women93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groupsin the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied.
CONCLUSION:In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection.
CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT01973036.</abstract><cop>United States</cop><pub>by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved</pub><pmid>29215519</pmid><doi>10.1097/AOG.0000000000002374</doi><tpages>8</tpages></addata></record> |
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source | MEDLINE; Journals@Ovid Complete |
subjects | Adult Cervical Ripening - drug effects Combined Modality Therapy Female Fetal Membranes, Premature Rupture - drug therapy Gestational Age Humans Infant, Newborn Infusions, Intravenous Labor, Induced - methods Oxytocin - administration & dosage Pregnancy Pregnancy Outcome Risk Assessment Urinary Catheterization - methods Young Adult |
title | Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial |
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