Official Title: “A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Labour induction with misoprostol
• Active Comparator: 2
  • Labour induction with dinoprostone
• Experimental: 3
  • Labour induction with bard

Primary Measures

• Time from treatment start to delivery
  • Time Frame: At delivery
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Karolinska University Hospital

Overall Clinical Trial Officials and Contacts

Lena Marions, MD PhD Principal Investigator Karolinska University Hospital Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00602095

Study ID Number: LMS2007

ClinicalTrials.gov Identifier: NCT00602095

Health Authority: Sweden: Regional Ethical Review Board