Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial

Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial

OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of ob...

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Main Authors: von Hertzen, H., Piaggio, G., Wojdyla, D., Marions, L., My Huong, N. T., Tang, O. S., Fang, A. H., Wu, S. C., Kalmar, L., Mittal, S., Erdenetungalag, R., Horga, M., Pretnar-Darovec, A., Kapamadzija, A., Dickson, K., Anh, N. D., Tai, N. V., Tuyet, H. T., Peregoudov, A.
Format: Journal Article
Language:EN
Published: 2012
Subjects:
Nonsteroidal Abortifacient Agents
effects
Steroidal Abortifacient Agents
Abortion, Induced
Adult
Drug Administration Schedule
Female
Humans
Mifepristone
Misoprostol
Pregnancy
First Pregnancy Trimester
Tablets
Treatment Outcome
Treatment Refusal
Online Access:http://hdl.handle.net/10986/5141
id okr-10986-5141
recordtype oai_dc
spelling okr-10986-51412021-04-23T14:02:21Z Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial von Hertzen, H. Piaggio, G. Wojdyla, D. Marions, L. My Huong, N. T. Tang, O. S. Fang, A. H. Wu, S. C. Kalmar, L. Mittal, S. Erdenetungalag, R. Horga, M. Pretnar-Darovec, A. Kapamadzija, A. Dickson, K. Anh, N. D. Tai, N. V. Tuyet, H. T. Peregoudov, A. Nonsteroidal Abortifacient Agents effects Steroidal Abortifacient Agents Abortion, Induced Adult Drug Administration Schedule Female Humans Mifepristone Misoprostol Pregnancy First Pregnancy Trimester Tablets Treatment Outcome Treatment Refusal OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of obstetrics and gynecology in nine countries. POPULATION: 2,181 women with 63 days or less gestation requesting medical abortion. METHODS: Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions. OUTCOME MEASURES: Rates of complete abortion without surgical intervention and adverse effects associated with the regimens. RESULTS: Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups. CONCLUSIONS: Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol. 2012-03-30T07:31:30Z 2012-03-30T07:31:30Z 2009 Journal Article BJOG 1471-0528 (Electronic) 1470-0328 (Linking) http://hdl.handle.net/10986/5141 EN http://creativecommons.org/licenses/by-nc-nd/3.0/igo World Bank Journal Article
repository_type Digital Repository
institution_category Foreign Institution
institution Digital Repositories
building World Bank Open Knowledge Repository
collection World Bank
language EN
topic Nonsteroidal Abortifacient Agents
effects
Steroidal Abortifacient Agents
Abortion, Induced
Adult
Drug Administration Schedule
Female
Humans
Mifepristone
Misoprostol
Pregnancy
First Pregnancy Trimester
Tablets
Treatment Outcome
Treatment Refusal
spellingShingle Nonsteroidal Abortifacient Agents
effects
Steroidal Abortifacient Agents
Abortion, Induced
Adult
Drug Administration Schedule
Female
Humans
Mifepristone
Misoprostol
Pregnancy
First Pregnancy Trimester
Tablets
Treatment Outcome
Treatment Refusal
von Hertzen, H.
Piaggio, G.
Wojdyla, D.
Marions, L.
My Huong, N. T.
Tang, O. S.
Fang, A. H.
Wu, S. C.
Kalmar, L.
Mittal, S.
Erdenetungalag, R.
Horga, M.
Pretnar-Darovec, A.
Kapamadzija, A.
Dickson, K.
Anh, N. D.
Tai, N. V.
Tuyet, H. T.
Peregoudov, A.
Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
relation http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of obstetrics and gynecology in nine countries. POPULATION: 2,181 women with 63 days or less gestation requesting medical abortion. METHODS: Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions. OUTCOME MEASURES: Rates of complete abortion without surgical intervention and adverse effects associated with the regimens. RESULTS: Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%, 95% CI: -4.0 to 0.5). Interaction between doses and interval to misoprostol administration was not significant (P = 0.92). Adverse effects related to treatments did not differ between the groups. CONCLUSIONS: Both the 100 and 200 mg doses of mifepristone and the 24- and 48-hour intervals have a similar efficacy to achieve complete abortion in early pregnancy when mifepristone is followed by 800 micrograms of vaginally administered misoprostol.
format Journal Article
author von Hertzen, H.
Piaggio, G.
Wojdyla, D.
Marions, L.
My Huong, N. T.
Tang, O. S.
Fang, A. H.
Wu, S. C.
Kalmar, L.
Mittal, S.
Erdenetungalag, R.
Horga, M.
Pretnar-Darovec, A.
Kapamadzija, A.
Dickson, K.
Anh, N. D.
Tai, N. V.
Tuyet, H. T.
Peregoudov, A.
author_facet von Hertzen, H.
Piaggio, G.
Wojdyla, D.
Marions, L.
My Huong, N. T.
Tang, O. S.
Fang, A. H.
Wu, S. C.
Kalmar, L.
Mittal, S.
Erdenetungalag, R.
Horga, M.
Pretnar-Darovec, A.
Kapamadzija, A.
Dickson, K.
Anh, N. D.
Tai, N. V.
Tuyet, H. T.
Peregoudov, A.
author_sort von Hertzen, H.
title Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
title_short Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
title_full Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
title_fullStr Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
title_full_unstemmed Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial
title_sort two mifepristone doses and two intervals of misoprostol administration for termination of early pregnancy : a randomised factorial controlled equivalence trial
publishDate 2012
url http://hdl.handle.net/10986/5141
_version_ 1764394099218055168

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