Viewing Study NCT00148473



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00148473
Status: COMPLETED
Last Update Posted: 2005-09-08
First Post: 2005-09-06

Brief Title: Oral Versus Vaginal Misoprostol for Induction of Labor
Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Organization: Bangkok Metropolitan Administration Medical College and Vajira Hospital

Study Overview

Official Title: A Single Dose of Oral Versus Vaginal Misoprostol for Induction of Labor A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2005-09
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 is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor
Detailed Description: Induction of labor is widely carried out all over the world in cases where continuation of pregnancy is hazardous to both the mother andor fetus The induction in a ripe cervix is not difficult but complications are significantly increased when the cervix is unripe The only agent approved for cervical ripening and induction of labor in patients with an unripe cervix is dinoprostonePGE2 Misoprostol is a synthetic PGE1 analogue marketed for the prevention and treatment of gastro-duodenal ulcers Misoprostol costs much less than dinoprostone and does not require refrigeration and has few systemic side effectsIn addition it is rapidly absorbed orally and vaginally Although misoprostol is not registered for such use it has been widely used for obstetric indications such as induction of abortion and of labor Misoprostol for induction of labor in preceding literatures mainly prescribed in multiple dosing regimen The adverse effects on uterus potentially occur owing to the frequent administration of misoprostol The objective of this study was to compare a single dose oral misoprostol with vaginal misoprostol

Study Oversight

Has Oversight DMC: None
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?: None