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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT00529295
Study type Interventional
Source China Medical University Hospital
Contact
Status Completed
Phase Phase 3
Start date June 2005
Completion date March 2007

See also
  Status Clinical Trial Phase
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Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
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Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2
Withdrawn NCT03218735 - Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus N/A
Completed NCT02639429 - Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial Phase 4