Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
Phase 3
Completed
- Conditions
- Pregnancy
- Interventions
- Registration Number
- NCT00602095
- Lead Sponsor
- Karolinska University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 592
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 misoprostol Labour induction with misoprostol 3 Bard Catheter (balloon catheter) Labour induction with bard 2 dinoprostone Labour induction with dinoprostone
- Primary Outcome Measures
Name Time Method Time from treatment start to delivery At delivery
- Secondary Outcome Measures
Name Time Method