NCT00602095

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods. The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found

Conditions

• Pregnancy

Interventions

Type	Name	Description
DRUG	misoprostol	0.025mg tablet vaginally every 4 hour until progress
DRUG	dinoprostone	2mg vaginal gel every 6 hours until progress
DEVICE	Bard Catheter (balloon catheter)	Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2008-01-28
• Last updated: 2008-01-28