Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-01-01 @ 1:23 PM
Study NCT ID:
NCT00529295
Status:
COMPLETED
Last Update Posted:
2007-09-14
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: