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Sponsored by: |
China Medical University Hospital |
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Information provided by: | China Medical University Hospital |
ClinicalTrials.gov Identifier: | NCT00529295 |
The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.
Condition | Intervention | Phase |
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Labor Induction |
Drug: misoprostol |
Phase III |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Parallel Assignment |
Enrollment: | 220 |
Study Start Date: | June 2005 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
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1: Experimental
Titrated oral misoprostol
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Drug: misoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
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2: Active Comparator
Vaginal misoprostol
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Drug: misoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
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Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
China Medical University Beigang Hospital | |
Yun Lin, Taiwan, 651 |
Principal Investigator: | Shi-Yann Cheng, M.D. | Chinal Medical University Beigang Hospital |
Study ID Numbers: | DMR95-IRB-116 |
Study First Received: | September 13, 2007 |
Last Updated: | September 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00529295 |
Health Authority: | Taiwan: Department of Health |
misoprostol labor induction |
Misoprostol |
Oxytocics Therapeutic Uses Anti-Ulcer Agents Physiological Effects of Drugs Abortifacient Agents |
Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |