Pregnancy
Conditions
Keywords
Labor induction, cervical ripening, misoprostol, dinoprostone, balloon catheter, prostaglandin
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
Interventions
DEVICEBard Catheter (balloon catheter)
Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
DRUGdinoprostone
2mg vaginal gel every 6 hours until progress
DRUGmisoprostol
0.025mg tablet vaginally every 4 hour until progress
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 ≤ 6. * Normal CTG registration
Exclusion criteria
* Previous cesarean section * signs of infection * immediate need for delivery * any contraindication for vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from treatment start to delivery | At delivery |
Outcome results
None listed