Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299754
Status:
COMPLETED
Last Update Posted:
2006-03-07
First Post:
2006-03-06
Brief Title:
Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming TROMAD Study
Sponsor:
KK Womens and Childrens Hospital
Organization:
KK Womens and Childrens Hospital
Study Overview
Official Title:
The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming TROMAD Study
Status:
COMPLETED
Status Verified Date:
2005-06
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:
Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary
Detailed Description:
171 women with singleton term pregnancies and modified Bishop score mBS 5 were recruited and randomized into 3 arms current dinoprostone regime double dose misoprostol or single dose misoprostol The primary outcome was the number of women who achieved favourable mBS6 or active labour by Day 2 Secondary outcomes were time interval from insert to active labour or delivery abnormal uterine activity delivery method and adverse neonatal outcome
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