Labour Induction With Misoprostol, Dinoprostone and Bard Catheter (LI)

Karolinska University Hospital

Status and phase: Completed; Phase 3

Conditions: Pregnancy

Treatments: Drug: dinoprostone; Device: Bard Catheter (balloon catheter); Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00602095

LMS2007

KS2007

Details and patient eligibility

About

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

Enrollment: 592 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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592 participants in 3 patient groups

1

Experimental group

Description:

Labour induction with misoprostol

Treatment:

Drug: misoprostol

2

Active Comparator group

Description:

Labour induction with dinoprostone

Treatment:

Drug: dinoprostone

3

Experimental group

Description:

Labour induction with bard

Treatment:

Device: Bard Catheter (balloon catheter)