Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination

BACKGROUND: It is not known whether a 400 microg dose of misoprostol has a similar efficacy as an 800 microg dose when administered sublingually or vaginally 24 hours after 200 mg mifepristone. METHODS: It is proposed to undertake a placebo-controlled, randomized, non-inferiority trial (3% margin of...

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Main Authors:	von Hertzen, H., Piaggio, G., Marions, L.
Format:	Journal Article
Language:	EN
Published:	2012
Online Access:	http://hdl.handle.net/10986/5140

id	okr-10986-5140
recordtype	oai_dc
spelling	okr-10986-51402021-04-23T14:02:21Z Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination von Hertzen, H. Piaggio, G. Marions, L. BACKGROUND: It is not known whether a 400 microg dose of misoprostol has a similar efficacy as an 800 microg dose when administered sublingually or vaginally 24 hours after 200 mg mifepristone. METHODS: It is proposed to undertake a placebo-controlled, randomized, non-inferiority trial (3% margin of equivalence) of the two misoprostol doses when administered sublingually or vaginally using factorial design. A total of 3008 pregnant women (< 63 days of gestational age) who request legal termination of pregnancy will be recruited for the trial at 16 clinics in ten countries providing abortion services. Eligible women willing to join the study will be allocated randomly to one of the four treatment groups within each centre. Women in all treatment groups will first receive 200 mg mifepristone, followed 24 hours later by either 400 microg or 800 microg misoprostol, administered either sublingually or vaginally. The dose and route of administration of misoprostol will be blinded to women, each woman receiving four tablets vaginally and four tablets sublingually, two or four of which are 200 microg tablets of misoprostol and the rest are placebo tablets.The four treatment regimens will be compared in terms of: (i) their efficacy to induce complete abortion; (ii) induction-to-abortion interval when possible; (iii) the frequency of side effects; and (iv) women's perceptions. The initial judgment of the outcome of treatment is made at the follow-up visit on day 15 of the study and the final assessment four weeks later. It is estimated that the clinical phase will require 12-14 months for data collection.To compare the two routes and two doses, relative risks (RR) of failure to achieve a complete abortion and failure to terminate pregnancy and the two-sided 95% CIs will be calculated by standard methods, as well as risk differences and two-sided 95% CIs. The latter will be used to test the non-inferiority hypotheses (at 2.5% level of significance) for achieving complete abortion. The factorial structure will be taken into account in the analysis after testing the interaction. TRIAL REGISTRATION: ISRCTN87811512. 2012-03-30T07:31:30Z 2012-03-30T07:31:30Z 2008 Journal Article Reprod Health 1742-4755 (Electronic) 1742-4755 (Linking) http://hdl.handle.net/10986/5140 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
relation	http://creativecommons.org/licenses/by-nc-nd/3.0/igo
description	BACKGROUND: It is not known whether a 400 microg dose of misoprostol has a similar efficacy as an 800 microg dose when administered sublingually or vaginally 24 hours after 200 mg mifepristone. METHODS: It is proposed to undertake a placebo-controlled, randomized, non-inferiority trial (3% margin of equivalence) of the two misoprostol doses when administered sublingually or vaginally using factorial design. A total of 3008 pregnant women (< 63 days of gestational age) who request legal termination of pregnancy will be recruited for the trial at 16 clinics in ten countries providing abortion services. Eligible women willing to join the study will be allocated randomly to one of the four treatment groups within each centre. Women in all treatment groups will first receive 200 mg mifepristone, followed 24 hours later by either 400 microg or 800 microg misoprostol, administered either sublingually or vaginally. The dose and route of administration of misoprostol will be blinded to women, each woman receiving four tablets vaginally and four tablets sublingually, two or four of which are 200 microg tablets of misoprostol and the rest are placebo tablets.The four treatment regimens will be compared in terms of: (i) their efficacy to induce complete abortion; (ii) induction-to-abortion interval when possible; (iii) the frequency of side effects; and (iv) women's perceptions. The initial judgment of the outcome of treatment is made at the follow-up visit on day 15 of the study and the final assessment four weeks later. It is estimated that the clinical phase will require 12-14 months for data collection.To compare the two routes and two doses, relative risks (RR) of failure to achieve a complete abortion and failure to terminate pregnancy and the two-sided 95% CIs will be calculated by standard methods, as well as risk differences and two-sided 95% CIs. The latter will be used to test the non-inferiority hypotheses (at 2.5% level of significance) for achieving complete abortion. The factorial structure will be taken into account in the analysis after testing the interaction. TRIAL REGISTRATION: ISRCTN87811512.
format	Journal Article
author	von Hertzen, H. Piaggio, G. Marions, L.
spellingShingle	von Hertzen, H. Piaggio, G. Marions, L. Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
author_facet	von Hertzen, H. Piaggio, G. Marions, L.
author_sort	von Hertzen, H.
title	Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
title_short	Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
title_full	Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
title_fullStr	Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
title_full_unstemmed	Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination
title_sort	comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination
publishDate	2012
url	http://hdl.handle.net/10986/5140
_version_	1764394095195717632

Comparison of Two Doses and Two Routes of Administration of Misoprostol after Pre-Treatment with Mifepristone for Early Pregnancy Termination

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