Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

Pregnancy Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602095
• Other study ID #: LMS2007
• Secondary ID: KS2007
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2008
• Last updated: January 15, 2008
• Start date: December 2004
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Full term singleton pregnancy with vertex presentation and with an indication for labour induction.

• Absence of active labour

• Bishop score = 6.

• Normal CTG registration

Exclusion Criteria:

• Previous cesarean section

• signs of infection

• immediate need for delivery

• any contraindication for vaginal delivery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• misoprostol
0.025mg tablet vaginally every 4 hour until progress
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from treatment start to delivery		At delivery	No