Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- Time from treatment start to delivery
- Time Frame: At delivery
Safety Issue?: No
- Time Frame: At delivery
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Karolinska University Hospital Other
Overall Clinical Trial Officials and Contacts
Lena Marions, MD PhD Principal Investigator Karolinska University Hospital Institute
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00602095
