Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308711
Status:
COMPLETED
Last Update Posted:
2012-06-25
First Post:
2006-03-27
Brief Title:
SafetyEfficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Multi-center Randomized Double-blind Phase III Study of the Efficacy and Safety of the Misoprostol Vaginal Insert Compared to Cervidil for Women Requiring Cervical Ripening and Induction of Labor The MVP Study
Status:
COMPLETED
Status Verified Date:
2012-06
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 determine whether the misoprostol vaginal insert 50 mcg and 100 mcg can safely and effectively speed time to vaginal delivery compared to Cervidil R in women who need to have cervical ripneing and induction of labor
Detailed Description:
Induction of labor is required in approximately 20 of pregnant women Although contractions can be brought on by oxytocin pitocin some women need help in softening the cervix or mouth of the womb uterus before oxytocin can be started Prostaglandins have been shown to ripen or soften the cervix at present the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone Dinoprostone can be delivered in several ways one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues This product is called Cervidil R and has been marketed for more than 10 years in the United States Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions but it is not approved by FDA for this purpose
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil Two different doses of misoprostol will be tested 50 micrograms and 100 micrograms each vaginal insert will gradually release a small controlled amount of misoprostol over up to 24 hours
Comparator The Cervidil R vaginal insert containing dinoprostone will be the comparator in this study
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil Two different doses of misoprostol will be tested 50 micrograms and 100 micrograms each vaginal insert will gradually release a small controlled amount of misoprostol over up to 24 hours
Comparator The Cervidil R vaginal insert containing dinoprostone will be the comparator in this study
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