Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: A randomized controlled trial
To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation. Double-blind, randomized controlled trial. Ten international centers. Eight hundred and ninety-six healthy women requesting medical abo...
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| Veröffentlicht in: | Acta obstetricia et gynecologica Scandinavica 2001-05, Vol.80 (5), p.447-451 |
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| container_title | Acta obstetricia et gynecologica Scandinavica |
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| creator | World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation WORLD HEALTH ORGANIZATION TASK FORCE ON POST-OVULATORY METHODS OF FERTILITY REGULATION (Note 1, Note 2) |
| description | To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation.
Double-blind, randomized controlled trial.
Ten international centers.
Eight hundred and ninety-six healthy women requesting medical abortion.
Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation. |
| doi_str_mv | 10.1034/j.1600-0412.2001.080005447.x |
| format | Article |
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Double-blind, randomized controlled trial.
Ten international centers.
Eight hundred and ninety-six healthy women requesting medical abortion.
Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.</description><identifier>ISSN: 0001-6349</identifier><identifier>EISSN: 1600-0412</identifier><identifier>DOI: 10.1034/j.1600-0412.2001.080005447.x</identifier><identifier>PMID: 11328223</identifier><identifier>CODEN: AOGSAE</identifier><language>eng</language><publisher>Colchester: Taylor & Francis</publisher><subject>Abortifacient Agents, Nonsteroidal - administration & dosage ; Abortifacient Agents, Steroidal - administration & dosage ; Abortion, Induced ; Administration, Intravaginal ; Administration, Oral ; Adult ; Alprostadil - administration & dosage ; Alprostadil - analogs & derivatives ; Biological and medical sciences ; China ; Double-Blind Method ; Drug Administration Schedule ; Europe ; Female ; Genital system. Reproduction ; Georgia (Republic) ; Hong Kong ; Humans ; India ; Medical sciences ; Mifepristone - administration & dosage ; Pharmacology. Drug treatments ; Pregnancy ; Pregnancy Trimester, First ; Slovenia ; Treatment Outcome ; United States</subject><ispartof>Acta obstetricia et gynecologica Scandinavica, 2001-05, Vol.80 (5), p.447-451</ispartof><rights>2001 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c347t-a139740c65d81f62cd667b5b2d49b12e803ebacd51d2f870b536634b7a68f9ab3</citedby><cites>FETCH-LOGICAL-c347t-a139740c65d81f62cd667b5b2d49b12e803ebacd51d2f870b536634b7a68f9ab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27915,27916</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=976764$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11328223$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation</creatorcontrib><creatorcontrib>WORLD HEALTH ORGANIZATION TASK FORCE ON POST-OVULATORY METHODS OF FERTILITY REGULATION (Note 1, Note 2)</creatorcontrib><title>Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: A randomized controlled trial</title><title>Acta obstetricia et gynecologica Scandinavica</title><addtitle>Acta Obstet Gynecol Scand</addtitle><description>To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation.
Double-blind, randomized controlled trial.
Ten international centers.
Eight hundred and ninety-six healthy women requesting medical abortion.
Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.</description><subject>Abortifacient Agents, Nonsteroidal - administration & dosage</subject><subject>Abortifacient Agents, Steroidal - administration & dosage</subject><subject>Abortion, Induced</subject><subject>Administration, Intravaginal</subject><subject>Administration, Oral</subject><subject>Adult</subject><subject>Alprostadil - administration & dosage</subject><subject>Alprostadil - analogs & derivatives</subject><subject>Biological and medical sciences</subject><subject>China</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Europe</subject><subject>Female</subject><subject>Genital system. Reproduction</subject><subject>Georgia (Republic)</subject><subject>Hong Kong</subject><subject>Humans</subject><subject>India</subject><subject>Medical sciences</subject><subject>Mifepristone - administration & dosage</subject><subject>Pharmacology. Drug treatments</subject><subject>Pregnancy</subject><subject>Pregnancy Trimester, First</subject><subject>Slovenia</subject><subject>Treatment Outcome</subject><subject>United States</subject><issn>0001-6349</issn><issn>1600-0412</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkFtP3DAQha2qqCxL_0JlqVV5SvAtdlLxglbcJFBf4NnyLa1XSdzGXgHtn2cWVsuT7TNnxnM-hL5RUlPCxem6ppKQigjKakYIrUlLCGmEUPXTB7TYFz-iBei0klx0h-go5zW8mBLtJ3RIKWctY3yB_t8FH50ZsLFpLjFN2BTcKFwSlhx785xP8K-Qi3mtPcbyGxs8pMcwY59ywKnHY-zDnznmkqaAzeTBP4KQcvmBz_EMShrjv-CxS1OZ0zDAtczRDMfooDdDDp935xI9XF7cr66r259XN6vz28pxoUplKO-UIE42vqW9ZM5LqWxjmRedpSy0hAdrnG-oZ32riG24hNBWGdn2nbF8ib6_zYWl_m4gjB5jdmEYzBTSJmsFBEUrKBjP3owOts9z6DXkGs38rCnRW_h6rbd89Zav3sLXe_j6Cdq_7P7Z2DH49-YdbTB83RlMBuY9sHEx732dkkoK_gIERY20</recordid><startdate>20010501</startdate><enddate>20010501</enddate><creator>World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation</creator><creator>WORLD HEALTH ORGANIZATION TASK FORCE ON POST-OVULATORY METHODS OF FERTILITY REGULATION (Note 1, Note 2)</creator><general>Taylor & Francis</general><scope>IQODW</scope><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>20010501</creationdate><title>Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: A randomized controlled trial</title></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c347t-a139740c65d81f62cd667b5b2d49b12e803ebacd51d2f870b536634b7a68f9ab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Abortifacient Agents, Nonsteroidal - administration & dosage</topic><topic>Abortifacient Agents, Steroidal - administration & dosage</topic><topic>Abortion, Induced</topic><topic>Administration, Intravaginal</topic><topic>Administration, Oral</topic><topic>Adult</topic><topic>Alprostadil - administration & dosage</topic><topic>Alprostadil - analogs & derivatives</topic><topic>Biological and medical sciences</topic><topic>China</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Europe</topic><topic>Female</topic><topic>Genital system. Reproduction</topic><topic>Georgia (Republic)</topic><topic>Hong Kong</topic><topic>Humans</topic><topic>India</topic><topic>Medical sciences</topic><topic>Mifepristone - administration & dosage</topic><topic>Pharmacology. Drug treatments</topic><topic>Pregnancy</topic><topic>Pregnancy Trimester, First</topic><topic>Slovenia</topic><topic>Treatment Outcome</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation</creatorcontrib><creatorcontrib>WORLD HEALTH ORGANIZATION TASK FORCE ON POST-OVULATORY METHODS OF FERTILITY REGULATION (Note 1, Note 2)</creatorcontrib><collection>Pascal-Francis</collection><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>Acta obstetricia et gynecologica Scandinavica</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><aucorp>World Health Organization Task Force on Post-ovulatory Methods of Fertility Regulation</aucorp><aucorp>WORLD HEALTH ORGANIZATION TASK FORCE ON POST-OVULATORY METHODS OF FERTILITY REGULATION (Note 1, Note 2)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: A randomized controlled trial</atitle><jtitle>Acta obstetricia et gynecologica Scandinavica</jtitle><addtitle>Acta Obstet Gynecol Scand</addtitle><date>2001-05-01</date><risdate>2001</risdate><volume>80</volume><issue>5</issue><spage>447</spage><epage>451</epage><pages>447-451</pages><issn>0001-6349</issn><eissn>1600-0412</eissn><coden>AOGSAE</coden><abstract>To compare the abortifacient efficacy and side-effects of 200 mg and 600 mg of mifepristone, followed by gemeprost 1 mg vaginally, at 57 to 63 days' gestation.
Double-blind, randomized controlled trial.
Ten international centers.
Eight hundred and ninety-six healthy women requesting medical abortion.
Participants were randomly assigned to receive a single oral dose of mifepristone of either 200 mg or 600 mg followed in 48 h by gemeprost 1 mg vaginally. The allocation sequence was concealed by using a central pharmacy, and double masking was maintained throughout the study.
Complete abortion rate was the principal outcome measure. We also evaluated the incidence of side-effects and time to abort.
The complete abortion rate with the lower dose of mifepristone was similar to that with the higher dose (92.4% vs. 91.7%). The relative risk of failure to achieve a complete abortion with the 200 mg dose compared to 600 mg dose was 0.9 (95% CI 0.6-1.4). The timing of the abortion and the incidence of side-effects were comparable in both groups, with the exception of reported nausea at one-week follow-up which was reported more frequently by women in the higher-dose group.
The 200 mg dose of mifepristone is equally as effective as the 600 mg dose in the antiprogestogen-prostaglandin regimen for pregnancy termination. With vaginal gemeprost, the abortifacient efficacy of the regimen remains high at 57-63 days' gestation.</abstract><cop>Colchester</cop><pub>Taylor & Francis</pub><pmid>11328223</pmid><doi>10.1034/j.1600-0412.2001.080005447.x</doi><tpages>5</tpages></addata></record> |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Abortifacient Agents, Nonsteroidal - administration & dosage Abortifacient Agents, Steroidal - administration & dosage Abortion, Induced Administration, Intravaginal Administration, Oral Adult Alprostadil - administration & dosage Alprostadil - analogs & derivatives Biological and medical sciences China Double-Blind Method Drug Administration Schedule Europe Female Genital system. Reproduction Georgia (Republic) Hong Kong Humans India Medical sciences Mifepristone - administration & dosage Pharmacology. Drug treatments Pregnancy Pregnancy Trimester, First Slovenia Treatment Outcome United States |
| title | Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: A randomized controlled trial |
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