Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438081
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-26
Brief Title:
Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Comparison Between Propess Dinoprostone Controlled Release Pessary and Cook Double-balloon Catheter for Cervical Priming a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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 investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy
Detailed Description:
Previous studies focused on use of PGE2 instead of Propess which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 03mg per hour for 24 hours Compared with PGE2 Propess can achieve a shorter induction-to-birth interval a higher rate of vaginal delivery within 24 hours and a smaller number of vaginal examinations during delivery However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None