A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 592
- Primary Endpoint
- Time from treatment start to delivery
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
- •Absence of active labour
- •Bishop score ≤
- •Normal CTG registration
Exclusion Criteria
- •Previous cesarean section
- •signs of infection
- •immediate need for delivery
- •any contraindication for vaginal delivery
Arms & Interventions
1
Labour induction with misoprostol
Intervention: misoprostol (Drug)
2
Labour induction with dinoprostone
Intervention: dinoprostone (Drug)
3
Labour induction with bard
Intervention: Bard Catheter (balloon catheter) (Device)
Outcomes
Primary Outcomes
Time from treatment start to delivery
Time Frame: At delivery
Secondary Outcomes
No secondary outcomes reported