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Article: Misoprostol dose and route after mifepristone for early medical abortion: A randomised controlled noninferiority trial

TitleMisoprostol dose and route after mifepristone for early medical abortion: A randomised controlled noninferiority trial
Authors
KeywordsFactorial design
medical abortion
mifepristone
misoprostol dose and route
Issue Date2010
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJOG
Citation
Bjog: An International Journal Of Obstetrics And Gynaecology, 2010, v. 117 n. 10, p. 1186-1196 How to Cite?
AbstractObjective To compare 400 and 800 g sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. Design Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 g, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. Setting Fifteen obstetricsgynaecology departments in ten countries. Population Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion. Methods Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. Outcome measures Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary). Results Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 g misoprostol, 94.2% after 800 g. Noninferiority of 400 g misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-g dose showed higher risk of incomplete abortion (P < 0.01) and continuing pregnancy (P < 0.01) than 800 g. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-g dose than the 800-g dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. Conclusions A 400-g dose of misoprostol should not replace the 800-g dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects. © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.
Persistent Identifierhttp://hdl.handle.net/10722/134487
ISSN
2015 Impact Factor: 4.039
2015 SCImago Journal Rankings: 2.083
ISI Accession Number ID
Funding AgencyGrant Number
UNDP/UNFPA/WHO/World Bank
Funding Information:

The study was funded by the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. We thank the members of the Data and Safety Monitoring Board for their contribution to interim analyses and their valuable comments on the manuscript.

References

 

DC FieldValueLanguage
dc.contributor.authorVon Hertzen, Hen_HK
dc.contributor.authorHuong, NTMen_HK
dc.contributor.authorPiaggio, Gen_HK
dc.contributor.authorBayalag, Men_HK
dc.contributor.authorCabezas, Een_HK
dc.contributor.authorFang, AHen_HK
dc.contributor.authorGemzellDanielsson, Ken_HK
dc.contributor.authorHinh, NDen_HK
dc.contributor.authorMittal, Sen_HK
dc.contributor.authorNg, EHYen_HK
dc.contributor.authorChaturachinda, Ken_HK
dc.contributor.authorPinter, Ben_HK
dc.contributor.authorPuscasiu, Len_HK
dc.contributor.authorSavardekar, Len_HK
dc.contributor.authorShenoy, Sen_HK
dc.contributor.authorKhomassuridge, Aen_HK
dc.contributor.authorTuyet, HTDen_HK
dc.contributor.authorVelasco, Aen_HK
dc.contributor.authorPeregoudov, Aen_HK
dc.date.accessioned2011-06-17T09:21:57Z-
dc.date.available2011-06-17T09:21:57Z-
dc.date.issued2010en_HK
dc.identifier.citationBjog: An International Journal Of Obstetrics And Gynaecology, 2010, v. 117 n. 10, p. 1186-1196en_HK
dc.identifier.issn1470-0328en_HK
dc.identifier.urihttp://hdl.handle.net/10722/134487-
dc.description.abstractObjective To compare 400 and 800 g sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. Design Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 g, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. Setting Fifteen obstetricsgynaecology departments in ten countries. Population Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion. Methods Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. Outcome measures Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary). Results Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 g misoprostol, 94.2% after 800 g. Noninferiority of 400 g misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-g dose showed higher risk of incomplete abortion (P < 0.01) and continuing pregnancy (P < 0.01) than 800 g. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-g dose than the 800-g dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. Conclusions A 400-g dose of misoprostol should not replace the 800-g dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects. © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.en_HK
dc.languageengen_US
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJOGen_HK
dc.relation.ispartofBJOG: An International Journal of Obstetrics and Gynaecologyen_HK
dc.rightsThe definitive version is available at www3.interscience.wiley.com-
dc.subjectFactorial designen_HK
dc.subjectmedical abortionen_HK
dc.subjectmifepristoneen_HK
dc.subjectmisoprostol dose and routeen_HK
dc.subject.meshAbortifacient Agents, Nonsteroidal - administration and dosage-
dc.subject.meshAbortifacient Agents, Steroidal - administration and dosage-
dc.subject.meshAbortion, Induced - methods-
dc.subject.meshMifepristone - administration and dosage-
dc.subject.meshMisoprostol - administration and dosage-
dc.titleMisoprostol dose and route after mifepristone for early medical abortion: A randomised controlled noninferiority trialen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=1470-0328&volume=117&issue=10&spage=1186&epage=1196&date=2010&atitle=Misoprostol+dose+and+route+after+mifepristone+for+early+medical+abortion:+a+randomised+controlled+noninferiority+trial-
dc.identifier.emailNg, EHY:nghye@hkucc.hku.hken_HK
dc.identifier.authorityNg, EHY=rp00426en_HK
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1111/j.1471-0528.2010.02636.xen_HK
dc.identifier.pmid20560941-
dc.identifier.scopuseid_2-s2.0-77955821321en_HK
dc.identifier.hkuros185499en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77955821321&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume117en_HK
dc.identifier.issue10en_HK
dc.identifier.spage1186en_HK
dc.identifier.epage1196en_HK
dc.identifier.isiWOS:000280989000003-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridVon Hertzen, H=7004390324en_HK
dc.identifier.scopusauthoridHuong, NTM=24472793300en_HK
dc.identifier.scopusauthoridPiaggio, G=7005979371en_HK
dc.identifier.scopusauthoridBayalag, M=36631589000en_HK
dc.identifier.scopusauthoridCabezas, E=8160947400en_HK
dc.identifier.scopusauthoridFang, AH=35313320200en_HK
dc.identifier.scopusauthoridGemzellDanielsson, K=7003551602en_HK
dc.identifier.scopusauthoridHinh, ND=8870066500en_HK
dc.identifier.scopusauthoridMittal, S=16444643600en_HK
dc.identifier.scopusauthoridNg, EHY=35238184300en_HK
dc.identifier.scopusauthoridChaturachinda, K=7005924863en_HK
dc.identifier.scopusauthoridPinter, B=6603669746en_HK
dc.identifier.scopusauthoridPuscasiu, L=25929536400en_HK
dc.identifier.scopusauthoridSavardekar, L=23969557900en_HK
dc.identifier.scopusauthoridShenoy, S=7103214726en_HK
dc.identifier.scopusauthoridKhomassuridge, A=36632236600en_HK
dc.identifier.scopusauthoridTuyet, HTD=16445227000en_HK
dc.identifier.scopusauthoridVelasco, A=16418099400en_HK
dc.identifier.scopusauthoridPeregoudov, A=6603256918en_HK
dc.identifier.citeulike7782666-

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