NCT06438081

Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming

Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 0.3mg 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.

Conditions

• Delivery Problem

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cook double-balloon catheter	To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-05-31
• Last updated: 2024-07-24

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study
• FDA-regulated device study