Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor

Background Misoprostol is an effective agent for the induction of labor. Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor. Objective The purpose of this study wa...

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Veröffentlicht in:American journal of obstetrics and gynecology 2017-04, Vol.216 (4), p.405.e1-405.e6
Hauptverfasser: Rouzi, Abdulrahim A., MBChB, Alsahly, Nora, MBChB, Alamoudi, Rana, MBChB, Almansouri, Nisma, MBChB, Alsinani, Nawal, MBChB, Alkafy, Souzan, MBChB, Rozzah, Rayyan, MBCHB, Abduljabbar, Hassan, MBChB
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container_end_page 405.e6
container_issue 4
container_start_page 405.e1
container_title American journal of obstetrics and gynecology
container_volume 216
creator Rouzi, Abdulrahim A., MBChB
Alsahly, Nora, MBChB
Alamoudi, Rana, MBChB
Almansouri, Nisma, MBChB
Alsinani, Nawal, MBChB
Alkafy, Souzan, MBChB
Rozzah, Rayyan, MBCHB
Abduljabbar, Hassan, MBChB
description Background Misoprostol is an effective agent for the induction of labor. Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor. Objective The purpose of this study was to compare efficacy and safety of hourly titrated-dose oral misoprostol solution with static-dose oral misoprostol solution every 2 hours for labor induction. Study Design In this randomized controlled study, oral misoprostol solution was administered as (1) 20 μg hourly (≤4 doses) that was increased in the absence of regular uterine contractions to 40 μg hourly (≤4 doses) and then to 60 μg hourly (≤16 doses) or (2) 25 μg every 2 hours until active labor began (≤12 doses). A sample size of 146 women was planned with the use of a projected 95% rate for the primary endpoint (vaginal delivery within 24 hours) for hourly titrated-dose misoprostol and 80% rate for static-dose misoprostol every 2 hours. Safety outcomes included maternal morbidity and adverse neonatal outcomes. Results From December 2013 to July 2015, 146 women were assigned randomly to treatment. Demographic and clinical factors were similar between groups, except for age. Vaginal delivery was achieved within 24 hours in 47 women (64.4%) who received hourly titrated-doses of misoprostol solution and 48 women (65.8%) who received 2-hourly static-dose misoprostol solution ( P =1.00). Rates of vaginal delivery within 24 hours did not differ significantly between treatment groups for women who were nulliparous ( P =1.00) or who had postterm pregnancies ( P =.66), a Bishop score of ≤3 ( P =.84), or oxytocin augmentation ( P =.83). Cesarean deliveries were performed within 24 hours in 9 women who received hourly titrated-dose misoprostol solution and 2 women who received 2-hourly static-dose misoprostol solution ( P =.056). Pyrexia and meconium-stained liquor occurred more frequently with the hourly titrated-dose regimen. Conclusion The static-dose oral misoprostol solution every 2 hours has similar efficacy as hourly titrated-dose misoprostol solution but with fewer side-effects and lower complication rates.
doi_str_mv 10.1016/j.ajog.2016.11.1054
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Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor. Objective The purpose of this study was to compare efficacy and safety of hourly titrated-dose oral misoprostol solution with static-dose oral misoprostol solution every 2 hours for labor induction. Study Design In this randomized controlled study, oral misoprostol solution was administered as (1) 20 μg hourly (≤4 doses) that was increased in the absence of regular uterine contractions to 40 μg hourly (≤4 doses) and then to 60 μg hourly (≤16 doses) or (2) 25 μg every 2 hours until active labor began (≤12 doses). A sample size of 146 women was planned with the use of a projected 95% rate for the primary endpoint (vaginal delivery within 24 hours) for hourly titrated-dose misoprostol and 80% rate for static-dose misoprostol every 2 hours. Safety outcomes included maternal morbidity and adverse neonatal outcomes. Results From December 2013 to July 2015, 146 women were assigned randomly to treatment. Demographic and clinical factors were similar between groups, except for age. Vaginal delivery was achieved within 24 hours in 47 women (64.4%) who received hourly titrated-doses of misoprostol solution and 48 women (65.8%) who received 2-hourly static-dose misoprostol solution ( P =1.00). Rates of vaginal delivery within 24 hours did not differ significantly between treatment groups for women who were nulliparous ( P =1.00) or who had postterm pregnancies ( P =.66), a Bishop score of ≤3 ( P =.84), or oxytocin augmentation ( P =.83). Cesarean deliveries were performed within 24 hours in 9 women who received hourly titrated-dose misoprostol solution and 2 women who received 2-hourly static-dose misoprostol solution ( P =.056). Pyrexia and meconium-stained liquor occurred more frequently with the hourly titrated-dose regimen. Conclusion The static-dose oral misoprostol solution every 2 hours has similar efficacy as hourly titrated-dose misoprostol solution but with fewer side-effects and lower complication rates.</description><identifier>ISSN: 0002-9378</identifier><identifier>EISSN: 1097-6868</identifier><identifier>DOI: 10.1016/j.ajog.2016.11.1054</identifier><identifier>PMID: 27986461</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Administration, Oral ; Adolescent ; Adult ; Cervical Ripening - drug effects ; Delivery, Obstetric ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Fever - epidemiology ; Humans ; Labor, Induced ; Meconium ; misoprostol ; Misoprostol - administration &amp; dosage ; Obstetrics and Gynecology ; oral ; Oxytocics - administration &amp; dosage ; Pregnancy ; solution ; static ; Time Factors ; titrated ; Young Adult</subject><ispartof>American journal of obstetrics and gynecology, 2017-04, Vol.216 (4), p.405.e1-405.e6</ispartof><rights>Elsevier Inc.</rights><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-2c64abc067d4b529eb4b5f04ce24755ce29d103119d00a3cf97107b3f00f80d63</citedby><cites>FETCH-LOGICAL-c459t-2c64abc067d4b529eb4b5f04ce24755ce29d103119d00a3cf97107b3f00f80d63</cites><orcidid>0000-0001-8601-0397</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajog.2016.11.1054$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27986461$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rouzi, Abdulrahim A., MBChB</creatorcontrib><creatorcontrib>Alsahly, Nora, MBChB</creatorcontrib><creatorcontrib>Alamoudi, Rana, MBChB</creatorcontrib><creatorcontrib>Almansouri, Nisma, MBChB</creatorcontrib><creatorcontrib>Alsinani, Nawal, MBChB</creatorcontrib><creatorcontrib>Alkafy, Souzan, MBChB</creatorcontrib><creatorcontrib>Rozzah, Rayyan, MBCHB</creatorcontrib><creatorcontrib>Abduljabbar, Hassan, MBChB</creatorcontrib><title>Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor</title><title>American journal of obstetrics and gynecology</title><addtitle>Am J Obstet Gynecol</addtitle><description>Background Misoprostol is an effective agent for the induction of labor. Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor. Objective The purpose of this study was to compare efficacy and safety of hourly titrated-dose oral misoprostol solution with static-dose oral misoprostol solution every 2 hours for labor induction. Study Design In this randomized controlled study, oral misoprostol solution was administered as (1) 20 μg hourly (≤4 doses) that was increased in the absence of regular uterine contractions to 40 μg hourly (≤4 doses) and then to 60 μg hourly (≤16 doses) or (2) 25 μg every 2 hours until active labor began (≤12 doses). A sample size of 146 women was planned with the use of a projected 95% rate for the primary endpoint (vaginal delivery within 24 hours) for hourly titrated-dose misoprostol and 80% rate for static-dose misoprostol every 2 hours. Safety outcomes included maternal morbidity and adverse neonatal outcomes. Results From December 2013 to July 2015, 146 women were assigned randomly to treatment. Demographic and clinical factors were similar between groups, except for age. Vaginal delivery was achieved within 24 hours in 47 women (64.4%) who received hourly titrated-doses of misoprostol solution and 48 women (65.8%) who received 2-hourly static-dose misoprostol solution ( P =1.00). Rates of vaginal delivery within 24 hours did not differ significantly between treatment groups for women who were nulliparous ( P =1.00) or who had postterm pregnancies ( P =.66), a Bishop score of ≤3 ( P =.84), or oxytocin augmentation ( P =.83). Cesarean deliveries were performed within 24 hours in 9 women who received hourly titrated-dose misoprostol solution and 2 women who received 2-hourly static-dose misoprostol solution ( P =.056). Pyrexia and meconium-stained liquor occurred more frequently with the hourly titrated-dose regimen. Conclusion The static-dose oral misoprostol solution every 2 hours has similar efficacy as hourly titrated-dose misoprostol solution but with fewer side-effects and lower complication rates.</description><subject>Administration, Oral</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Cervical Ripening - drug effects</subject><subject>Delivery, Obstetric</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Fever - epidemiology</subject><subject>Humans</subject><subject>Labor, Induced</subject><subject>Meconium</subject><subject>misoprostol</subject><subject>Misoprostol - administration &amp; dosage</subject><subject>Obstetrics and Gynecology</subject><subject>oral</subject><subject>Oxytocics - administration &amp; dosage</subject><subject>Pregnancy</subject><subject>solution</subject><subject>static</subject><subject>Time Factors</subject><subject>titrated</subject><subject>Young Adult</subject><issn>0002-9378</issn><issn>1097-6868</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUU1v1DAQtRAV3RZ-ARLykUuWsZM48QEkVAFFqoTUgsTNcuwJOHjjYjtF21-Pw3Y5cOHi8Yzem4_3CHnOYMuAiVfTVk_h25aX_5axUmubR2TDQHaV6EX_mGwAgFey7vpTcpbStKZc8ifklHeyF41gG3J3rWcbdu4eLTXezc5oT3N05R0w_0Kc6fewRL-n2eWoc4EVAuXHaso6O0NDLISdS-E2hpSDpyn4Jbsw0zFE6ma7mD9ZGKnXQ4hPycmofcJnD_GcfHn_7vPFZXX16cPHi7dXlWlamStuRKMHA6KzzdByiUMJIzQGedO1bQnSMqgZkxZA12aUHYNuqEeAsQcr6nPy8tC37PVzwZRVWdKg93rGsCTF-pYLWYNcofUBasoJKeKobqPb6bhXDNQquJrUKrhaBVeMqVXwwnrxMGAZdmj_co4KF8DrAwDLmXcOo0rG4WzQuogmKxvcfwa8-Yd_tOkH7jFNxYa5KKiYSlyBullNXi1nouZMyK_1b5MRqNo</recordid><startdate>20170401</startdate><enddate>20170401</enddate><creator>Rouzi, Abdulrahim A., MBChB</creator><creator>Alsahly, Nora, MBChB</creator><creator>Alamoudi, Rana, MBChB</creator><creator>Almansouri, Nisma, MBChB</creator><creator>Alsinani, Nawal, MBChB</creator><creator>Alkafy, Souzan, MBChB</creator><creator>Rozzah, Rayyan, MBCHB</creator><creator>Abduljabbar, Hassan, MBChB</creator><general>Elsevier Inc</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><orcidid>https://orcid.org/0000-0001-8601-0397</orcidid></search><sort><creationdate>20170401</creationdate><title>Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor</title><author>Rouzi, Abdulrahim A., MBChB ; Alsahly, Nora, MBChB ; Alamoudi, Rana, MBChB ; Almansouri, Nisma, MBChB ; Alsinani, Nawal, MBChB ; Alkafy, Souzan, MBChB ; Rozzah, Rayyan, MBCHB ; Abduljabbar, Hassan, MBChB</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-2c64abc067d4b529eb4b5f04ce24755ce29d103119d00a3cf97107b3f00f80d63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Administration, Oral</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Cervical Ripening - drug effects</topic><topic>Delivery, Obstetric</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Fever - epidemiology</topic><topic>Humans</topic><topic>Labor, Induced</topic><topic>Meconium</topic><topic>misoprostol</topic><topic>Misoprostol - administration &amp; dosage</topic><topic>Obstetrics and Gynecology</topic><topic>oral</topic><topic>Oxytocics - administration &amp; dosage</topic><topic>Pregnancy</topic><topic>solution</topic><topic>static</topic><topic>Time Factors</topic><topic>titrated</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rouzi, Abdulrahim A., MBChB</creatorcontrib><creatorcontrib>Alsahly, Nora, MBChB</creatorcontrib><creatorcontrib>Alamoudi, Rana, MBChB</creatorcontrib><creatorcontrib>Almansouri, Nisma, MBChB</creatorcontrib><creatorcontrib>Alsinani, Nawal, MBChB</creatorcontrib><creatorcontrib>Alkafy, Souzan, MBChB</creatorcontrib><creatorcontrib>Rozzah, Rayyan, MBCHB</creatorcontrib><creatorcontrib>Abduljabbar, Hassan, MBChB</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>American journal of obstetrics and gynecology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rouzi, Abdulrahim A., MBChB</au><au>Alsahly, Nora, MBChB</au><au>Alamoudi, Rana, MBChB</au><au>Almansouri, Nisma, MBChB</au><au>Alsinani, Nawal, MBChB</au><au>Alkafy, Souzan, MBChB</au><au>Rozzah, Rayyan, MBCHB</au><au>Abduljabbar, Hassan, MBChB</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor</atitle><jtitle>American journal of obstetrics and gynecology</jtitle><addtitle>Am J Obstet Gynecol</addtitle><date>2017-04-01</date><risdate>2017</risdate><volume>216</volume><issue>4</issue><spage>405.e1</spage><epage>405.e6</epage><pages>405.e1-405.e6</pages><issn>0002-9378</issn><eissn>1097-6868</eissn><abstract>Background Misoprostol is an effective agent for the induction of labor. Existing guidelines recommend oral misoprostol solution 25 μg every 2 hours. However, more research is required to optimize the use of oral misoprostol solution for the induction of labor. Objective The purpose of this study was to compare efficacy and safety of hourly titrated-dose oral misoprostol solution with static-dose oral misoprostol solution every 2 hours for labor induction. Study Design In this randomized controlled study, oral misoprostol solution was administered as (1) 20 μg hourly (≤4 doses) that was increased in the absence of regular uterine contractions to 40 μg hourly (≤4 doses) and then to 60 μg hourly (≤16 doses) or (2) 25 μg every 2 hours until active labor began (≤12 doses). A sample size of 146 women was planned with the use of a projected 95% rate for the primary endpoint (vaginal delivery within 24 hours) for hourly titrated-dose misoprostol and 80% rate for static-dose misoprostol every 2 hours. Safety outcomes included maternal morbidity and adverse neonatal outcomes. Results From December 2013 to July 2015, 146 women were assigned randomly to treatment. Demographic and clinical factors were similar between groups, except for age. Vaginal delivery was achieved within 24 hours in 47 women (64.4%) who received hourly titrated-doses of misoprostol solution and 48 women (65.8%) who received 2-hourly static-dose misoprostol solution ( P =1.00). Rates of vaginal delivery within 24 hours did not differ significantly between treatment groups for women who were nulliparous ( P =1.00) or who had postterm pregnancies ( P =.66), a Bishop score of ≤3 ( P =.84), or oxytocin augmentation ( P =.83). Cesarean deliveries were performed within 24 hours in 9 women who received hourly titrated-dose misoprostol solution and 2 women who received 2-hourly static-dose misoprostol solution ( P =.056). Pyrexia and meconium-stained liquor occurred more frequently with the hourly titrated-dose regimen. Conclusion The static-dose oral misoprostol solution every 2 hours has similar efficacy as hourly titrated-dose misoprostol solution but with fewer side-effects and lower complication rates.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27986461</pmid><doi>10.1016/j.ajog.2016.11.1054</doi><orcidid>https://orcid.org/0000-0001-8601-0397</orcidid><oa>free_for_read</oa></addata></record>
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ispartof American journal of obstetrics and gynecology, 2017-04, Vol.216 (4), p.405.e1-405.e6
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source MEDLINE; Elsevier ScienceDirect Journals
subjects Administration, Oral
Adolescent
Adult
Cervical Ripening - drug effects
Delivery, Obstetric
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Fever - epidemiology
Humans
Labor, Induced
Meconium
misoprostol
Misoprostol - administration & dosage
Obstetrics and Gynecology
oral
Oxytocics - administration & dosage
Pregnancy
solution
static
Time Factors
titrated
Young Adult
title Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor
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