Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
Information source: Karolinska University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: misoprostol (Drug); dinoprostone (Drug); Bard Catheter (balloon catheter) (Device)
Phase: Phase 3
Status: Completed
Sponsored by: Karolinska University Hospital Official(s) and/or principal investigator(s):
Lena Marions, MD PhD, Principal Investigator, Affiliation: Karolinska University Hospital Institute
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
Clinical Details
Official title: A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time from treatment start to delivery
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: December 2004
Ending date: March 2007
Last updated: January 15, 2008
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