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Article: Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: A randomised trial

TitleComparison of two doses of mifepristone in combination with misoprostol for early medical abortion: A randomised trial
Authors
Issue Date2000
PublisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJOG
Citation
British Journal Of Obstetrics And Gynaecology, 2000, v. 107 n. 4, p. 524-530 How to Cite?
AbstractObjectives. To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of ≤ 35 days. Design. Double-blind, randomised controlled trial. Setting. Seventeen centres internationally. Participants. We enrolled 1589 healthy pregnant women with menstrual delay of ≤ 35 days who were requesting nonsurgical abortion. Interventions. Within gestational age strata, we randomly assigned women to receive a single oral dose of mifepristone, either 200 mg or 600 mg, followed in 48 h by misoprostol 400 μg by mouth. We concealed the allocation assignments from investigators and participants and maintained double-blinding throughout the study. Main outcome measures. Complete abortion was the principal outcome measure. We also compared rates of side effects such as abdominal pain. Results. The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (89.3% vs 88.1%) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 (95% CI 0.7 to 1.2). The likelihood of complete abortion was inversely related to gestational age, although this finding is exploratory in nature. Among failures the percentage of women with continuing pregnancies increased from 1.4% at menstrual delay of two weeks or less to 9.0% when the delay was 4-5 weeks. Low efficacy led to stopping enrolment at 29 to 35 days' menstrual delay. Stopping criteria were also met at completion of the study in the group with 22-28 days' menstrual delay. No significant differences emerged in the frequency of side effects between the two mifepristone groups. Conclusions. Both regimens had similar efficacy. Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses. The efficacy of the mifepristone-prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg. The regimens of 600 mg or 200 mg of mifepristone, followed by a single oral dose of misoprostol 400 μg 48 hours later, were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days.
Persistent Identifierhttp://hdl.handle.net/10722/173051
ISSN
2001 Impact Factor: 2.321
References

 

DC FieldValueLanguage
dc.contributor.authorVon Hertzen, Hen_US
dc.contributor.authorWu, YMen_US
dc.contributor.authorGomezAlzugaray, Men_US
dc.contributor.authorHaukkamaa, Men_US
dc.contributor.authorNgoc, NTNen_US
dc.contributor.authorHo, PCen_US
dc.contributor.authorPretnarDarovec, Aen_US
dc.contributor.authorHealy, DLen_US
dc.contributor.authorSotnikova, Een_US
dc.contributor.authorShah, RSen_US
dc.contributor.authorPavlova, NGen_US
dc.contributor.authorChen, JKen_US
dc.contributor.authorSong, Sen_US
dc.contributor.authorBygdeman, Men_US
dc.contributor.authorKovács, Len_US
dc.contributor.authorKhomassuridze, Aen_US
dc.contributor.authorSong, LJen_US
dc.contributor.authorHamzaoui, Ren_US
dc.contributor.authorAlexaniants, Sen_US
dc.contributor.authorVan Look, Aen_US
dc.contributor.authorPiaggio, Gen_US
dc.contributor.authorPeregoudov, Aen_US
dc.contributor.authorVucurevic, Men_US
dc.contributor.authorGrimes, Den_US
dc.date.accessioned2012-10-30T06:27:42Z-
dc.date.available2012-10-30T06:27:42Z-
dc.date.issued2000en_US
dc.identifier.citationBritish Journal Of Obstetrics And Gynaecology, 2000, v. 107 n. 4, p. 524-530en_US
dc.identifier.issn0306-5456en_US
dc.identifier.urihttp://hdl.handle.net/10722/173051-
dc.description.abstractObjectives. To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of ≤ 35 days. Design. Double-blind, randomised controlled trial. Setting. Seventeen centres internationally. Participants. We enrolled 1589 healthy pregnant women with menstrual delay of ≤ 35 days who were requesting nonsurgical abortion. Interventions. Within gestational age strata, we randomly assigned women to receive a single oral dose of mifepristone, either 200 mg or 600 mg, followed in 48 h by misoprostol 400 μg by mouth. We concealed the allocation assignments from investigators and participants and maintained double-blinding throughout the study. Main outcome measures. Complete abortion was the principal outcome measure. We also compared rates of side effects such as abdominal pain. Results. The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (89.3% vs 88.1%) The crude relative risk of failure to achieve complete abortion with the 200 mg dose compared with the 600 mg dose was 0.9 (95% CI 0.7 to 1.2). The likelihood of complete abortion was inversely related to gestational age, although this finding is exploratory in nature. Among failures the percentage of women with continuing pregnancies increased from 1.4% at menstrual delay of two weeks or less to 9.0% when the delay was 4-5 weeks. Low efficacy led to stopping enrolment at 29 to 35 days' menstrual delay. Stopping criteria were also met at completion of the study in the group with 22-28 days' menstrual delay. No significant differences emerged in the frequency of side effects between the two mifepristone groups. Conclusions. Both regimens had similar efficacy. Women with a menstrual delay of four to five weeks had twice the risk of failure to abort compared with those who received treatment within two weeks of the expected menses. The efficacy of the mifepristone-prostaglandin regimen was not reduced by decreasing the dose of mifepristone from 600 mg to 200 mg. The regimens of 600 mg or 200 mg of mifepristone, followed by a single oral dose of misoprostol 400 μg 48 hours later, were not sufficiently efficient in inducing abortion when the menstrual delay was > 21 days.en_US
dc.languageengen_US
dc.publisherBlackwell Publishing Ltd. The Journal's web site is located at http://www.blackwellpublishing.com/journals/BJOGen_US
dc.relation.ispartofBritish Journal of Obstetrics and Gynaecologyen_US
dc.rightsBritish Journal of Obstetrics & Gynaecology. Copyright © Blackwell Publishing Ltd.-
dc.subject.meshAbortifacient Agents, Nonsteroidal - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshAbortion, Induced - Methodsen_US
dc.subject.meshAdulten_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDrug Administration Scheduleen_US
dc.subject.meshFemaleen_US
dc.subject.meshGestational Ageen_US
dc.subject.meshHumansen_US
dc.subject.meshLogistic Modelsen_US
dc.subject.meshMisoprostol - Administration & Dosage - Adverse Effectsen_US
dc.subject.meshPregnancyen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleComparison of two doses of mifepristone in combination with misoprostol for early medical abortion: A randomised trialen_US
dc.typeArticleen_US
dc.identifier.emailHo, PC:pcho@hku.hken_US
dc.identifier.authorityHo, PC=rp00325en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1111/j.1471-0528.2000.tb13273.x-
dc.identifier.pmid10759273-
dc.identifier.scopuseid_2-s2.0-0005662148en_US
dc.identifier.hkuros49566-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0005662148&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume107en_US
dc.identifier.issue4en_US
dc.identifier.spage524en_US
dc.identifier.epage530en_US
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridVon Hertzen, H=7004390324en_US
dc.identifier.scopusauthoridWu, YM=7406891698en_US
dc.identifier.scopusauthoridGomezAlzugaray, M=6506187382en_US
dc.identifier.scopusauthoridHaukkamaa, M=7004408717en_US
dc.identifier.scopusauthoridNgoc, NTN=6701559699en_US
dc.identifier.scopusauthoridHo, PC=7402211440en_US
dc.identifier.scopusauthoridPretnarDarovec, A=6602910640en_US
dc.identifier.scopusauthoridHealy, DL=24453312600en_US
dc.identifier.scopusauthoridSotnikova, E=7006013857en_US
dc.identifier.scopusauthoridShah, RS=7403034621en_US
dc.identifier.scopusauthoridPavlova, NG=36872887000en_US
dc.identifier.scopusauthoridChen, JK=7501889344en_US
dc.identifier.scopusauthoridSong, S=8959016300en_US
dc.identifier.scopusauthoridBygdeman, M=7101634701en_US
dc.identifier.scopusauthoridKovács, L=24348044800en_US
dc.identifier.scopusauthoridKhomassuridze, A=6603094731en_US
dc.identifier.scopusauthoridSong, LJ=7402538048en_US
dc.identifier.scopusauthoridHamzaoui, R=36765572700en_US
dc.identifier.scopusauthoridAlexaniants, S=6505973422en_US
dc.identifier.scopusauthoridVan Look, A=6503935049en_US
dc.identifier.scopusauthoridPiaggio, G=7005979371en_US
dc.identifier.scopusauthoridPeregoudov, A=6603256918en_US
dc.identifier.scopusauthoridVucurevic, M=6506259373en_US
dc.identifier.scopusauthoridGrimes, D=36045728400en_US

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